<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02231125</url>
  </required_header>
  <id_info>
    <org_study_id>S2014-039-01</org_study_id>
    <nct_id>NCT02231125</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy</brief_title>
  <official_title>Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chen Xiangmei</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu Suzhong Pharmaceutical Group Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is&#xD;
      a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has&#xD;
      been widely used to treat kidney disease. The purpose of this study is to evaluate the safety&#xD;
      and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with&#xD;
      long time take.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The test has not been completed .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 24-h proteinuria from baseline after treatment</measure>
    <time_frame>Baseline(week 0), week 4, week 12, week 24, week 36, week 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in serum creatinine from baseline after treatment</measure>
    <time_frame>Baseline(week 0), week 4, week 12, week 24, week 36, week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in estimated glomerular filtration rate (eGFR) from baseline after treatment</measure>
    <time_frame>Baseline(week 0), week 4, week 12, week 24, week 36, week 48</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1600</enrollment>
  <condition>IgA Nephropathy</condition>
  <arm_group>
    <arm_group_label>Abelmoschus manihot (AM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abelmoschus manihot (AM): Huangkui capsule (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.), 0.5 g × 30 capsules/box. A huangkui capsule is a single plant drug extract of Flos Abelmoschus manihot.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Losartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Losartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Losartan</intervention_name>
    <description>Losartan potassium tablet 100mg/time, once /day plus Huangkui Capsule dummy 2.5g/time, thrice /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.</description>
    <arm_group_label>Losartan</arm_group_label>
    <other_name>Cozaar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abelmoschus manihot</intervention_name>
    <description>Huangkui Capsule 2.5g/time, thrice /day plus Losartan potassium tablet dummy 100mg/time, once /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.</description>
    <arm_group_label>Abelmoschus manihot (AM)</arm_group_label>
    <other_name>Huangkui Capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosed as chronic nephritic syndrome&#xD;
&#xD;
          -  IgA nephropathy diagnosed by kidney biopsy&#xD;
&#xD;
          -  Aged from 18 to 65 years，male or female&#xD;
&#xD;
          -  Blood pressure of ≤140/90mmHg&#xD;
&#xD;
          -  Estimated Glomerular Filtration Rate (eGFR)≥45ml/min/1.73 m2&#xD;
&#xD;
          -  24-hour proteinuria ranged between 0.5g-3.0g&#xD;
&#xD;
          -  Obtaining the signed informed consent from patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary IgA nephropathy&#xD;
&#xD;
          -  Be allergic to Huangkui Capsule or Losartan potassium tablet&#xD;
&#xD;
          -  Taken Huangkui Capsule or ACEI or ARB in last 6 weeks&#xD;
&#xD;
          -  Taken the glucocorticoids, immunosuppressants or common threewingnut root and such as&#xD;
             drugs with immunosuppressive actions in the last 12 months&#xD;
&#xD;
          -  Blood pressure &lt;90/60mmHg&#xD;
&#xD;
          -  Serum potassium level &gt; 5.5mmol / L&#xD;
&#xD;
          -  Serum albumin level &lt;30g / L&#xD;
&#xD;
          -  Lactation, pregnancy or plans pregnancy during the study period&#xD;
&#xD;
          -  Unilateral or bilateral renal artery stenosis&#xD;
&#xD;
          -  Combined with severe primary diseases of heart, brain, liver and hematopoietic system&#xD;
             and so on, or other serious diseases which can affect the patient's life&#xD;
&#xD;
          -  Participating in another clinical study in the same period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiangmei Chen, MD.&amp; Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nephrology,State Key Laboratory of Kidney Disease,National Clinical Research Center for Kidney Disease, Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiangmei Chen, MD.&amp;Ph.D</last_name>
    <phone>+86-10-66935462</phone>
    <email>xmchen301@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xuefeng Sun, MD.&amp;Ph.D</last_name>
    <phone>+86-10-66937077</phone>
    <email>xfssun@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Beijing Chao-yang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>China-Japan Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenge Li</last_name>
      <phone>+86-13521961922</phone>
      <email>wenge_lee2002@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Dong Zhi Men Hospital of Beijing University of Chinese Medicine</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Guang An Men Hospital China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>PLA Navy General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Second Artillery General Hospital Of Chinese People's Liberation Army</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaowen Tu</last_name>
      <phone>+86-18910883406</phone>
      <email>xiaowentu@sohu.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Da Ping Hospital Of Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Yongchuan Hospital Of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Chinese People's Liberation Army No.180 Hospital</name>
      <address>
        <city>Quanzhou</city>
        <state>Fujian</state>
        <zip>362000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Cheng</last_name>
      <phone>+86-13313835596</phone>
      <email>cl20060606@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chinese People's Liberation Army No.174 Hospital</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tianxi Liu</last_name>
      <phone>+86-13919060937</phone>
      <email>liutianxi@medmail.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianqin Wang</last_name>
      <phone>+86-13919038189</phone>
      <email>wangjianqin@medmail.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>421 Hospital of PLA</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chaoxin Xie</last_name>
      <phone>+86-13332889488</phone>
      <email>xcx421@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangdong Province Hospital of Traditional Chinese Medicine(TCM)</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xusheng Liu</last_name>
      <phone>+86-13503078703</phone>
      <email>liuxu801@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Guilin Medical University</name>
      <address>
        <city>Guilin</city>
        <state>Guangxi</state>
        <zip>541000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangxi University of Chinese Medicine</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Guiyang Medical College</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Affiliated Baiyun Hospital of Guizhou Medical University</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital Of Zun Yi Medical College</name>
      <address>
        <city>Zunyi</city>
        <state>Guizhou</state>
        <zip>563000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yibin Yang</last_name>
      <phone>+86-13765930909</phone>
      <email>yyb1011@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hainan Medical College Affiliated Hospital</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <zip>570100</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hainan Provincial Nong Ken Hospital</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <zip>570100</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Cheng De Medical College</name>
      <address>
        <city>Chengde</city>
        <state>Hebei</state>
        <zip>067000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>First Hospital of Qinhuangdao</name>
      <address>
        <city>Qinhuangdao</city>
        <state>Hebei</state>
        <zip>066000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hebei Province Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>TCM Hospital of Shi Jia Zhuang City</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuxia Fu</last_name>
      <phone>+86-15803210953</phone>
      <email>fushuxia99@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Heilongjiang Provincial Academy of Traditional Chinese Medicine</name>
      <address>
        <city>Haerbin</city>
        <state>Heilongjiang</state>
        <zip>150000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Harbin Medical University</name>
      <address>
        <city>Haerbin</city>
        <state>Heilongjiang</state>
        <zip>150000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Henan University of Science And Technology</name>
      <address>
        <city>Luoyang</city>
        <state>Henan</state>
        <zip>471000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xinxiang Medical University</name>
      <address>
        <city>Xinxiang</city>
        <state>Henan</state>
        <zip>453000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Minghao Guo</last_name>
      <phone>+86-13937315636</phone>
      <email>guomh@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fengmin Shao</last_name>
      <phone>+86-13607655698</phone>
      <email>fengminshao@medmail.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Huang Gang Central Hospital</name>
      <address>
        <city>Huanggang</city>
        <state>Hubei</state>
        <zip>438000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hubei Provincial Hospital Of TCM</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Wuhan Integrated TCM &amp; Western Medicine Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Zhong Nan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Second Xiang Ya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Third Xiang Ya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Sun</last_name>
      <phone>+86-13505199810</phone>
      <email>jssunwei@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangsu Provincial People's Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Nantong University</name>
      <address>
        <city>Nantong</city>
        <state>Jiangsu</state>
        <zip>226000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yaping Fan</last_name>
      <phone>+86-15962998446</phone>
      <email>fanyp19107@medmail.com.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangsu Taizhou People's Hospital</name>
      <address>
        <city>Taizhou</city>
        <state>Jiangsu</state>
        <zip>225300</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Taizhou Traditional Chinese Medicine Hospital</name>
      <address>
        <city>Taizhou</city>
        <state>Jiangsu</state>
        <zip>225300</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Xuzhou Central Hospital</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Chinese People's Liberation Army No.94 Hospital</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Jiangxi Provincial People's Hospital</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital Of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Jiangxi Pingxiang People's Hospital</name>
      <address>
        <city>Pingxiang</city>
        <state>Jiangxi</state>
        <zip>337000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Jilin Province People's Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Second Hospital Of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Dalian Municipal Central Hospital Affiliated Of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital Of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Liaoning Medical University</name>
      <address>
        <city>Jinzhou</city>
        <state>Liaoning</state>
        <zip>121000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>People's Liberation Army No.202 Hospital</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Hospital Of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The General Hospital Of Shenyang Military Region</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ningxia Hui Autonomous Region's Hospital</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <zip>750000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yali Zheng</last_name>
      <phone>+86-13639505291</phone>
      <email>424570556@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The General Hospital of Ningxia Medical University</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <zip>750000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Jinan General Hospital of PLA</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Qi Lu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Jining Medical University</name>
      <address>
        <city>Jining</city>
        <state>Shandong</state>
        <zip>272000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Jining No.1 People's Hospital</name>
      <address>
        <city>Jining</city>
        <state>Shandong</state>
        <zip>272000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Chinese People's Liberation Army No.88 Hospital</name>
      <address>
        <city>Taian</city>
        <state>Shandong</state>
        <zip>271000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Yantai Yu Huang Ding Hospital</name>
      <address>
        <city>Yantai</city>
        <state>Shandong</state>
        <zip>264000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Zaozhuang Municipal Hospital</name>
      <address>
        <city>Zaozhuang</city>
        <state>Shandong</state>
        <zip>277100</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Chang Hai Hospital of the Second Military Medical University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Shanxi Provincial People's Hospital</name>
      <address>
        <city>Xian</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiao Tong University</name>
      <address>
        <city>Xian</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hua Xi Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Tianjin Medical University</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Tianjin Hospital of ITCWM, Nankai Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Shi He Zi Medical University</name>
      <address>
        <city>Shihezi</city>
        <state>Xinjiang</state>
        <zip>832000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoping Yang</last_name>
      <phone>+86-13579458071</phone>
      <email>sbkyxp@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Kunming Medical University</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Yan'an Hospital of Kunming City</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinwen Wang</last_name>
      <phone>+86-13700697545</phone>
      <email>wjwyayy@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Zhang L, Li P, Xing CY, Zhao JY, He YN, Wang JQ, Wu XF, Liu ZS, Zhang AP, Lin HL, Ding XQ, Yin AP, Yuan FH, Fu P, Hao L, Miao LN, Xie RJ, Wang R, Zhou CH, Guan GJ, Hu Z, Lin S, Chang M, Zhang M, He LQ, Mei CL, Wang L, Chen X. Efficacy and safety of Abelmoschus manihot for primary glomerular disease: a prospective, multicenter randomized controlled clinical trial. Am J Kidney Dis. 2014 Jul;64(1):57-65. doi: 10.1053/j.ajkd.2014.01.431. Epub 2014 Mar 14.</citation>
    <PMID>24631042</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>July 4, 2016</last_update_submitted>
  <last_update_submitted_qc>July 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Chen Xiangmei</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Abelmoschus manihot</keyword>
  <keyword>IgA Nephropathy</keyword>
  <keyword>proteinuria</keyword>
  <keyword>efficacy</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Glomerulonephritis, IGA</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Losartan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02231125
org study id: S2014-039-01
nct id: NCT02231125
lead sponsor: 
collaborator: 
has dmc: Yes
-IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is
      a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has
      been widely used to treat kidney disease. The purpose of this study is to evaluate the safety
      and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with
      long time take.
The test has not been completed .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Change in 24-h proteinuria from baseline after treatment
time frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48
measure: Change in serum creatinine from baseline after treatment
time frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48
measure: Change in estimated glomerular filtration rate (eGFR) from baseline after treatment
time frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48
arm group label: Abelmoschus manihot (AM)
arm group type: Experimental
description: Abelmoschus manihot (AM): Huangkui capsule (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.), 0.5 g × 30 capsules/box. A huangkui capsule is a single plant drug extract of Flos Abelmoschus manihot.
arm group label: Losartan
arm group type: Experimental
description: Losartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box.
intervention type: Drug
intervention name: Losartan
description: Losartan potassium tablet 100mg/time, once /day plus Huangkui Capsule dummy 2.5g/time, thrice /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.
arm group label: Losartan
other name: Cozaar
intervention type: Drug
intervention name: Abelmoschus manihot
description: Huangkui Capsule 2.5g/time, thrice /day plus Losartan potassium tablet dummy 100mg/time, once /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.
arm group label: Abelmoschus manihot (AM)
other name: Huangkui Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xiangmei Chen, MD.& Ph.D
role: Principal Investigator
affiliation: Department of Nephrology,State Key Laboratory of Kidney Disease,National Clinical Research Center for Kidney Disease, Chinese PLA General Hospital
last name: Xiangmei Chen, MD.&Ph.D
phone: +86-10-66935462
email: xmchen301@126.com
last name: Xuefeng Sun, MD.&Ph.D
phone: +86-10-66937077
email: xfssun@126.com
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
country: China
citation: Zhang L, Li P, Xing CY, Zhao JY, He YN, Wang JQ, Wu XF, Liu ZS, Zhang AP, Lin HL, Ding XQ, Yin AP, Yuan FH, Fu P, Hao L, Miao LN, Xie RJ, Wang R, Zhou CH, Guan GJ, Hu Z, Lin S, Chang M, Zhang M, He LQ, Mei CL, Wang L, Chen X. Efficacy and safety of Abelmoschus manihot for primary glomerular disease: a prospective, multicenter randomized controlled clinical trial. Am J Kidney Dis. 2014 Jul;64(1):57-65. doi: 10.1053/j.ajkd.2014.01.431. Epub 2014 Mar 14.
PMID: 24631042
responsible party type: Sponsor-Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Chen Xiangmei
investigator title: professor
mesh term: Kidney Diseases
mesh term: Glomerulonephritis, IGA
mesh term: Losartan
sharing ipd: No