xml: <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/NCT06006689</url>
    </required_header>
    <id_info>
      <org_study_id>TSL-TCM-QSYQDW-DKD-Ⅱ</org_study_id>
      <nct_id>NCT06006689</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)</brief_title>
    <official_title>A Randomized, Double-blind, Multi-center, Standardise-loaded, Placebo-parallel Controlled Clinical Trial of Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tasly Pharmaceutical Group Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tasly Pharmaceutical Group Co., Ltd</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will evaluate the efficacy and Safety of QiShen YiQi Dripping Pills in the&#xD;
        treatment of Diabetic Kidney Disease (syndrome of Qi deficiency with blood stasis)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio).</measure>
      <time_frame>Baseline to weeks 4, 8 and 12</time_frame>
      <description>Change in UACR from baseline to weeks 4, 8 and 12.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ratio of subjects with UACR returned to normal.</measure>
      <time_frame>Baseline to weeks 4, 8 and 12</time_frame>
      <description>Ratio of subjects with UACR returned to normal at weeks 4, 8 and 12.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ratio of subjects with UACR decrease of more than 30% from baseline.</measure>
      <time_frame>Baseline to weeks 4, 8 and 12</time_frame>
      <description>Ratio of subjects with UACR decrease of more than 30% from baseline at weeks 4, 8 and 12.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ratio of subjects from microalbuminuria stage to macroalbuminuria</measure>
      <time_frame>Baseline to weeks 4, 8 and 12</time_frame>
      <description>Ratio of subjects from microalbuminuria stage to macroalbuminuria at weeks 4, 8 and 12.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in eGFR(estimated glomerular filtration rate).</measure>
      <time_frame>Baseline to weeks 4, 8 and 12</time_frame>
      <description>Change in eGFR from baseline to weeks 4, 8 and 12.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Traditional Chinese Medicine Syndrome Score</measure>
      <time_frame>Baseline to weeks 4, 8 and 12</time_frame>
      <description>Change in Traditional Chinese Medicine Syndrome Score from baseline to weeks 4, 8 and 12. There were 9 clinical primary symptoms, 7 clinical secondary symptoms, tongue picture and pulse condition evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM primary symptoms and secondary symptoms scored as without 0, light 2, medium 4, heavy 6 points. Tongue picture and pulse condition did not count.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TCM syndrome</measure>
      <time_frame>Baseline to weeks 4, 8 and 12</time_frame>
      <description>Number and ratio of subjects with Clinical recovery, obvious effect, effective or ineffective in curative effect of TCM syndrome at weeks 4, 8 and 12.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in β2-MG.</measure>
      <time_frame>Baseline to weeks 4, 8 and 12</time_frame>
      <description>Change in β2-MG from baseline to weeks 4, 8 and 12.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Cys-C.</measure>
      <time_frame>Baseline to weeks 4, 8 and 12</time_frame>
      <description>Change in Cys-C from baseline to weeks 4, 8 and 12.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in PCX.</measure>
      <time_frame>Baseline to week 12</time_frame>
      <description>Change in PCX from baseline to week 12.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in MCP-1.</measure>
      <time_frame>Baseline to week 12</time_frame>
      <description>Change in MCP-1 from baseline to week 12.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">228</enrollment>
    <condition>Diabetic Kidney Disease</condition>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Low dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High dose group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>High dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Qishen Yiqi Dripping Pills placebo 3 bags</intervention_name>
      <description>Qishen Yiqi Dripping Pills placebo contain Qishen Yiqi dripping pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks</description>
      <arm_group_label>Placebo group</arm_group_label>
      <other_name>Placebo group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Low dose Qishen Yiqi Dripping Pills 3 bags</intervention_name>
      <description>Low dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 2 bags(0.52g dripping pills per bag) and Qishen Yiqi dripping pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks</description>
      <arm_group_label>Low dose group</arm_group_label>
      <other_name>Low dose group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>High dose Qishen Yiqi Dripping Pills 3 bags</intervention_name>
      <description>High dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks</description>
      <arm_group_label>High dose group</arm_group_label>
      <other_name>High dose group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Man or woman between 18-75 years-old&#xD;
  &#xD;
            -  Subjects with type 2 diabetes mellitus&#xD;
  &#xD;
            -  Subjects with a clinical diagnosis of diabetic kidney disease&#xD;
  &#xD;
            -  eGFR≥ 45 mL/min/1.73 m2&#xD;
  &#xD;
            -  UACR ≥ 30 mg/g but ≤ 300 mg/g&#xD;
  &#xD;
            -  Conformed to the TCM syndrome differentiation standard of chronic heart failure&#xD;
               syndrome of Qi deficiency and blood stasis&#xD;
  &#xD;
            -  Received Steady dose of ACEI or ARB therapy for chronic heart failure at least 2 weeks&#xD;
               before receiving investigational drug&#xD;
  &#xD;
            -  Abide by the experimental protocol and cooperate with the data collection according to&#xD;
               the researcher's judgment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with type 1 diabetes mellitus or other specific types of diabetes&#xD;
  &#xD;
            -  Acute complications of diabetes such as diabetic ketoacidosis and hyperosmolar&#xD;
               hyperglycemia occurred in the past 3 months&#xD;
  &#xD;
            -  HbA1c ≥8.5% or fasting blood glucose &gt;11 mmol/L&#xD;
  &#xD;
            -  Urinary sediment indicates &quot;active&quot; glomerulogenic hematuria&#xD;
  &#xD;
            -  Subjects have been clinically confirmed cases of primary glomerular disease, secondary&#xD;
               glomerular disease other than DKD or other systemic diseases&#xD;
  &#xD;
            -  The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/or&#xD;
               diastolic blood pressure ≥100mmHg or Hypotension with a systolic blood pressure&#xD;
               &lt;90mmHg and/or a diastolic blood pressure &lt;60mmHg&#xD;
  &#xD;
            -  ALT or AST&gt; 2 times the upper limit of normal&#xD;
  &#xD;
            -  Serum potassium&gt; the upper limit of normal&#xD;
  &#xD;
            -  Patients with unstable basic treatment for lowering blood glucose and blood lipids&#xD;
               within the past 3 months, and patients with unstable basic treatment for lowering&#xD;
               blood pressure within the past 1 month (changing the type of drugs, such as changing&#xD;
               the β-receptor blockers to calcium ion antagonists, etc.)&#xD;
  &#xD;
            -  Take the following medications within the last 2 weeks：a. Other drugs for the&#xD;
               treatment of DKD (Finerenone, Keluoxin capsule, Qizhi Yishen capsule, SGLT2i drugs,&#xD;
               GLP-1 drugs, etc.), b. Calcium oxybenzenesulfonate for the treatment of diabetic&#xD;
               retinopathy, c. Chinese patent medicine, Chinese medicine decoction, formula granule&#xD;
               and other Chinese medicine preparations with the same composition or function&#xD;
               indications, d. Tripterygium wilfordii related preparations, Huangkui capsule&#xD;
  &#xD;
            -  Patients who need to take antiplatelet drugs, the dose was stable for less than 1&#xD;
               month&#xD;
  &#xD;
            -  Serious diseases of other systemic systems that may affect the judgment of efficacy&#xD;
               and safety&#xD;
  &#xD;
            -  A history of alcohol or drug abuse with a combination of mental illness and poor&#xD;
               control&#xD;
  &#xD;
            -  Allergic to the experimental drug or its ingredients&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding, or who have a need to have children during&#xD;
               the trial&#xD;
  &#xD;
            -  Participating in other clinical studies and taking investigational drugs from other&#xD;
               studies within 3 months prior to screening&#xD;
  &#xD;
            -  The investigator deems that the patient is not suitable to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Rui Liu</last_name>
      <phone>022-86343626</phone>
      <email>liurui2@tasly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dongzhimen Hospital of Beijing University of Chinese Medicine</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Shidong Wang</last_name>
        <phone>010-84012709</phone>
        <email>dzmk@163.net</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xiyuan Hospital of China Academy of Chinese Medical Sciences</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Renhuan Yu</last_name>
        <phone>010-62835646</phone>
        <email>xiyuan5649@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Affiliated TCM Hospital of Guangzhou Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wenying Wang</last_name>
        <phone>020-81226210</phone>
        <email>gcp6335@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hebei Province Hospital of Traditional Chinese Medicine</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jinchuan Tan</last_name>
        <phone>0311-69095606</phone>
        <email>szyyyxllh@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Heilongjiang Academy of Traditional Chinese Medicine (Heilongjiang Provincial Hospital of Traditional Chinese Medicine)</name>
        <address>
          <city>Ha'erbin</city>
          <state>Heilongjiang</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiaojun Cai</last_name>
        <phone>0451-86096799</phone>
        <email>30393458@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Kaifeng Hospital of Traditional Chinese Medicine</name>
        <address>
          <city>Kaifeng</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Fang Zhang</last_name>
        <phone>0371-22868815</phone>
        <email>kfszyyllwyh@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Luoyang Third People's Hospital</name>
        <address>
          <city>Luoyang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Junhang Tian</last_name>
        <phone>0379-63963566</phone>
        <email>lysygcp@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sanmenxia Central Hospital</name>
        <address>
          <city>Sanmenxia</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yunchou Ning</last_name>
        <phone>0398-3118657</phone>
        <email>zxyyjgb888@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Hunan University of Chinese Medicine</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiaoling Zou</last_name>
        <phone>0731-85369039</phone>
        <email>zyfyjigouban@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shananxi Province Hospital of Traditional Chinese Medicine</name>
        <address>
          <city>Xi'an</city>
          <state>Shananxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yang Xiao</last_name>
        <phone>029-87251691</phone>
        <email>sxzyjgb@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hua Yang</last_name>
        <phone>021-64385700</phone>
        <email>lhgcpoffice@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanghai Sixth People's Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Niansong Wang</last_name>
        <phone>021-24056429</phone>
        <email>liuyuangcp@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>West China Hospital of Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Li Zhou</last_name>
        <phone>028-85423237</phone>
        <email>huaxigcp@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Bin Wang</last_name>
        <phone>022-27986257</phone>
        <email>yfyjdb@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hangzhou hospital of traditional Chinese medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hongyu Chen</last_name>
        <phone>0571-85827896</phone>
        <email>hzgxgcp@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Chao Zheng</last_name>
        <phone>0571-87783759</phone>
        <email>ruanzr@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Diabetic Nephropathies</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006689
  org study id: TSL-TCM-QSYQDW-DKD-Ⅱ
  nct id: NCT06006689
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will evaluate the efficacy and Safety of QiShen YiQi Dripping Pills in the
        treatment of Diabetic Kidney Disease (syndrome of Qi deficiency with blood stasis)
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in UACR(urinary albumin ⁃ to ⁃ creatinine ratio).
  time frame: Baseline to weeks 4, 8 and 12
  description: Change in UACR from baseline to weeks 4, 8 and 12.
  measure: Ratio of subjects with UACR returned to normal.
  time frame: Baseline to weeks 4, 8 and 12
  description: Ratio of subjects with UACR returned to normal at weeks 4, 8 and 12.
  measure: Ratio of subjects with UACR decrease of more than 30% from baseline.
  time frame: Baseline to weeks 4, 8 and 12
  description: Ratio of subjects with UACR decrease of more than 30% from baseline at weeks 4, 8 and 12.
  measure: Ratio of subjects from microalbuminuria stage to macroalbuminuria
  time frame: Baseline to weeks 4, 8 and 12
  description: Ratio of subjects from microalbuminuria stage to macroalbuminuria at weeks 4, 8 and 12.
  measure: Change in eGFR(estimated glomerular filtration rate).
  time frame: Baseline to weeks 4, 8 and 12
  description: Change in eGFR from baseline to weeks 4, 8 and 12.
  measure: Change in Traditional Chinese Medicine Syndrome Score
  time frame: Baseline to weeks 4, 8 and 12
  description: Change in Traditional Chinese Medicine Syndrome Score from baseline to weeks 4, 8 and 12. There were 9 clinical primary symptoms, 7 clinical secondary symptoms, tongue picture and pulse condition evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM primary symptoms and secondary symptoms scored as without 0, light 2, medium 4, heavy 6 points. Tongue picture and pulse condition did not count.
  measure: TCM syndrome
  time frame: Baseline to weeks 4, 8 and 12
  description: Number and ratio of subjects with Clinical recovery, obvious effect, effective or ineffective in curative effect of TCM syndrome at weeks 4, 8 and 12.
  measure: Change in β2-MG.
  time frame: Baseline to weeks 4, 8 and 12
  description: Change in β2-MG from baseline to weeks 4, 8 and 12.
  measure: Change in Cys-C.
  time frame: Baseline to weeks 4, 8 and 12
  description: Change in Cys-C from baseline to weeks 4, 8 and 12.
  measure: Change in PCX.
  time frame: Baseline to week 12
  description: Change in PCX from baseline to week 12.
  measure: Change in MCP-1.
  time frame: Baseline to week 12
  description: Change in MCP-1 from baseline to week 12.
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: Qishen Yiqi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day
  arm group label: Low dose group
  arm group type: Experimental
  description: Low dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day
  arm group label: High dose group
  arm group type: Experimental
  description: High dose Qishen Yiqi Dripping Pills, 3 bags, take orally after meals, 3 times a day
  intervention type: Drug
  intervention name: Qishen Yiqi Dripping Pills placebo 3 bags
  description: Qishen Yiqi Dripping Pills placebo contain Qishen Yiqi dripping pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
  arm group label: Placebo group
  other name: Placebo group
  intervention type: Drug
  intervention name: Low dose Qishen Yiqi Dripping Pills 3 bags
  description: Low dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 2 bags(0.52g dripping pills per bag) and Qishen Yiqi dripping pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
  arm group label: Low dose group
  other name: Low dose group
  intervention type: Drug
  intervention name: High dose Qishen Yiqi Dripping Pills 3 bags
  description: High dose Qishen Yiqi Dripping Pills contain Qishen Yiqi dripping pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
  arm group label: High dose group
  other name: High dose group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Rui Liu
  phone: 022-86343626
  email: liurui2@tasly.com
  facility: 
  contact: 
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  country: China
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Diabetic Nephropathies