<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/NCT02231138</url>
  </required_header>
  <id_info>
    <org_study_id>S2014-040-01</org_study_id>
    <nct_id>NCT02231138</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease</brief_title>
  <official_title>Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease：a Multicentre Open Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</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>
      Huangkui Capsule is a single medicament of traditional Chinese medicine consists of&#xD;
      Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this&#xD;
      study is to evaluate the safety and efficacy of Abelmoschus manihot for treating chronic&#xD;
      kidney disease in large scale samples with 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>Active, not recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 24-h proteinuria from baseline after treatment</measure>
    <time_frame>Baseline(week 0), week 12, week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in the serum creatinine level from baseline after treatment</measure>
    <time_frame>Baseline(week 0), week 12, week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in the estimated glomerular filtration rate (eGFR) from baseline after treatment</measure>
    <time_frame>Baseline(week 0), week 12, week 24</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1600</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Abelmoschus manihot (AM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>age above 12 years old (including 12)：huangkui capsule are given orally at 2.5 g three times per day&#xD;
age between 6-12 years old(including 6):huangkui capsule are given orally at 1.5 g three times per day&#xD;
age under 6 years old：huangkui capsule are given orally at 1.0 g three times per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abelmoschus manihot (AM)</intervention_name>
    <description>Abelmoschus manihot (AM): Huanghui 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_label>Abelmoschus manihot (AM)</arm_group_label>
    <other_name>Huanghui capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosed as non-ESRD chronic kidney disease (stage I-IV)&#xD;
&#xD;
          -  Blood pressure of ≤140/90mmHg&#xD;
&#xD;
          -  Obtaining the signed informed consent from patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Be allergic to Huangkui Capsule&#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;
          -  Lactation, pregnancy or plans pregnancy during the study period&#xD;
&#xD;
          -  Participating in another clinical study in the same period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</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>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <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>
  </location>
  <location>
    <facility>
      <name>Beijing Military General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>PLA Air Force General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PLA Navy General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of General Hospital of PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Xin Qiao Hospital Of Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese People's Liberation Army No.180 Hospital</name>
      <address>
        <city>Quanzhou</city>
        <state>Fujian</state>
        <zip>362008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese People's Liberation Army No.174 Hospital</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361001</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </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>
  </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>
  </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>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Guizhou Province Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </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>
  </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>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>First Hospital of Qinhuangdao</name>
      <address>
        <city>Qinhuangdao</city>
        <state>Hebei</state>
        <zip>066000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital Of Heilongjiang University of Chinese Medicine</name>
      <address>
        <city>Haerbin</city>
        <state>Heilongjiang</state>
        <zip>150000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </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>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Huang Gang Central Hospital</name>
      <address>
        <city>Huanggang</city>
        <state>Hubei</state>
        <zip>438000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Union Hospital Tong Ji Medical College Hua Zhong University Of Science And Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Xiang Ya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Baotou Medical College</name>
      <address>
        <city>Baotou</city>
        <state>Inner Mongolia</state>
        <zip>014000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </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>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Xuzhou Central Hospital</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </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>
  </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>
  </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>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>The Second Hospital Of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </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>
  </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>
  </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>
  </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>
  </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>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Zaozhuang Municipal Hospital</name>
      <address>
        <city>Zaozhuang</city>
        <state>Shandong</state>
        <zip>277100</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Shanghai East Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Ninth 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>
  </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>
  </location>
  <location>
    <facility>
      <name>Shu Guang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Hospital of Integrated Traditional And Western Medicine</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Provincial People's Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Chengdu University of Traditional Chinese Medicine</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The third People's Hospital of Chengdu</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>
  </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>
  </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>
  </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>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </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>May 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>May 31, 2016</last_update_submitted>
  <last_update_submitted_qc>May 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Xiangmei Chen</investigator_full_name>
    <investigator_title>professsor</investigator_title>
  </responsible_party>
  <keyword>Abelmoschus manihot</keyword>
  <keyword>Chronic Kidney Disease</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>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The test has not been completed.</ipd_description>
  </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/NCT02231138
org study id: S2014-040-01
nct id: NCT02231138
lead sponsor: 
collaborator: 
has dmc: Yes
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 chronic
      kidney disease in large scale samples with long time take.
The test has not been completed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in 24-h proteinuria from baseline after treatment
time frame: Baseline(week 0), week 12, week 24
measure: change in the serum creatinine level from baseline after treatment
time frame: Baseline(week 0), week 12, week 24
measure: change in the estimated glomerular filtration rate (eGFR) from baseline after treatment
time frame: Baseline(week 0), week 12, week 24
arm group label: Abelmoschus manihot (AM)
arm group type: Experimental
description: age above 12 years old (including 12)：huangkui capsule are given orally at 2.5 g three times per day
age between 6-12 years old(including 6):huangkui capsule are given orally at 1.5 g three times per day
age under 6 years old：huangkui capsule are given orally at 1.0 g three times per day
intervention type: Drug
intervention name: Abelmoschus manihot (AM)
description: Abelmoschus manihot (AM): Huanghui 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: Abelmoschus manihot (AM)
other name: Huanghui capsule
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Xiangmei Chen, MD.& Ph.D
role: Principal Investigator
affiliation: Chinese PLA General Hospital
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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: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Xiangmei Chen
investigator title: professsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No
ipd description: The test has not been completed.