<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/NCT03009864</url>
  </required_header>
  <id_info>
    <org_study_id>201507001-11Tangshen</org_study_id>
    <nct_id>NCT03009864</nct_id>
  </id_info>
  <brief_title>The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage</brief_title>
  <official_title>The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhengzhou City Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shijiazhuang City Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baoding City Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hubei Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changchun Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xingtai City Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medicine Zibo Wanjie Tumor Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zouping Country Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>She Country Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital of TCM</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baishi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2&#xD;
      diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200mg/min) to&#xD;
      evaluate the therapeutic effect of tang shen prescription. 632 participants will be recruited&#xD;
      for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal,&#xD;
      and no evidence of non-diabetic renal diseases. The subjects will be randomized to treatment&#xD;
      with either tang shen prescription or placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2&#xD;
      diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200ug/min) to&#xD;
      evaluate the therapeutic effect of tang shen prescription.632 participants will be recruited&#xD;
      for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal,&#xD;
      and no evidence of non-diabetic renal diseases. The study will last for 24 weeks. Subjects&#xD;
      will be randomly divided into two groups, either tang shen prescription or placebo，and both&#xD;
      of them would be performed on a basic treatment which includes diabetes education, diabetic&#xD;
      diet, rational control of blood glucose, and losartan at 50 mg daily, study group take tang&#xD;
      wang prescription. Measurements of microalbuminuria excretion rate, albumin-to-creatinine&#xD;
      ration, glomerular filtration rate (GFR), serum creatinine concentrations will be tested&#xD;
      monthly, and quantity of 24h urinary protein per three months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <phase>Early Phase 1</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>changes of albumin-to-creatinine ration</measure>
    <time_frame>0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of participants of diabetic kidney disease in macroalbuminuria stage</measure>
    <time_frame>0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants whose microalbuminuria excretion rate &lt; 20ug/min</measure>
    <time_frame>0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of GFR</measure>
    <time_frame>0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the rate of doubling the baseline with serum creatinine value</measure>
    <time_frame>0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">632</enrollment>
  <condition>Diabetic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Tangshen Prescription</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Treatment with placebo corresponding to each dose of Tangshen Prescription&#xD;
, every bag weighs 4.87g, take it one bag each time, two times a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tangshen Prescription</intervention_name>
    <description>The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Tangshen Prescription</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Treatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Tangshen Prescription</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of type 2 diabetic Kidney Disease in early stage;&#xD;
&#xD;
          2. Aged 30-70;&#xD;
&#xD;
          3. Signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-diabetic renal disease, such as gout, essential hypertension, tumors, and chronic&#xD;
             kidney disease which may cause proteinuria or microalbuminuria.&#xD;
&#xD;
          2. Cardiovascular disease、hepatopathy、kidney disease and hematopoietic disease et al, the&#xD;
             serum transaminase was two times larger than the normal valuet、serum creatinine&#xD;
             concentration greater than the upper limit of normal value and psychiatric disease.&#xD;
&#xD;
          3. Women with Pregnancy or prepare for pregnancy or lactating.&#xD;
&#xD;
          4. Degree of renal failure have developed to the stage of hypoxemia and uremia.&#xD;
&#xD;
          5. Patients participate in other clinical researchers within a month.&#xD;
&#xD;
          6. Patients have been treated with the angiotensin receptor blocker (ARB) drugs to treat&#xD;
             diabetic kidney disease except for losartan within a month.&#xD;
&#xD;
          7. Patients have been treated with angiotensin-converting enzyme inhibitors (ACEI) drugs&#xD;
             to treat diabetic kidney disease within a month.&#xD;
&#xD;
          8. Systolic blood pressure over 160mmHg or diastolic blood pressure over 100mmHg.&#xD;
&#xD;
          9. Patients with diabetic ketosis, ketoacidosis and severe infections within a month.&#xD;
&#xD;
         10. Patients addicting alcohol, psychoactive substances within 5 years.&#xD;
&#xD;
         11. According to the researcher's judgment, there are other diseases or situations that&#xD;
             can reduce the possibility of entering the group or complicate the group, such as&#xD;
             frequent changes in the working environment and unstable living environment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fengmei Lian, PHD</last_name>
    <phone>0086-010-88001402</phone>
    <email>lfm565@sohu.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Fengmei Lian, PHD</last_name>
      <phone>0086-010-88001402</phone>
      <email>lfm565@sohu.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Lian-fengmei</investigator_full_name>
    <investigator_title>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</investigator_title>
  </responsible_party>
  <keyword>Diabetic Kidney Disease</keyword>
  <keyword>TCM</keyword>
  <keyword>RCT</keyword>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03009864
org study id: 201507001-11Tangshen
nct id: NCT03009864
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2
      diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200mg/min) to
      evaluate the therapeutic effect of tang shen prescription. 632 participants will be recruited
      for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal,
      and no evidence of non-diabetic renal diseases. The subjects will be randomized to treatment
      with either tang shen prescription or placebo.
This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2
      diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200ug/min) to
      evaluate the therapeutic effect of tang shen prescription.632 participants will be recruited
      for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal,
      and no evidence of non-diabetic renal diseases. The study will last for 24 weeks. Subjects
      will be randomly divided into two groups, either tang shen prescription or placebo，and both
      of them would be performed on a basic treatment which includes diabetes education, diabetic
      diet, rational control of blood glucose, and losartan at 50 mg daily, study group take tang
      wang prescription. Measurements of microalbuminuria excretion rate, albumin-to-creatinine
      ration, glomerular filtration rate (GFR), serum creatinine concentrations will be tested
      monthly, and quantity of 24h urinary protein per three months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: changes of albumin-to-creatinine ration
time frame: 0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
measure: number of participants of diabetic kidney disease in macroalbuminuria stage
time frame: 0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks
measure: number of participants whose microalbuminuria excretion rate < 20ug/min
time frame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
measure: change of GFR
time frame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
measure: the rate of doubling the baseline with serum creatinine value
time frame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
arm group label: Tangshen Prescription
arm group type: Experimental
description: The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.
arm group label: Placebo
arm group type: Placebo Comparator
description: Treatment with placebo corresponding to each dose of Tangshen Prescription
, every bag weighs 4.87g, take it one bag each time, two times a day.
intervention type: Drug
intervention name: Tangshen Prescription
description: The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.
arm group label: Placebo
arm group label: Tangshen Prescription
intervention type: Drug
intervention name: Placebos
description: Treatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day.
arm group label: Placebo
arm group label: Tangshen Prescription
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Fengmei Lian, PHD
phone: 0086-010-88001402
email: lfm565@sohu.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
investigator full name: Lian-fengmei
investigator title: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies
sharing ipd: Undecided