<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/NCT03025399</url>
  </required_header>
  <id_info>
    <org_study_id>2015Tangwang Prescription</org_study_id>
    <nct_id>NCT03025399</nct_id>
  </id_info>
  <brief_title>Clinical Study of Tang Wang Prescription Intervene Diabetic Non-proliferative Retinopathy</brief_title>
  <official_title>Multi Center Clinical Study of Chinese Medicine Intervention on Early Diabetic Microvascular Complications: Multi Centers Clinical Study of Tang Wang Prescription Intervene Diabetic Non-proliferative Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fengmei Lian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui University 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>Zhengzhou City Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baodin City Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>zi bo wanjie cancer hospital</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>Zouping Country Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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 include 384 Participants with diabetic non-proliferative retinopathy&#xD;
&#xD;
      Design Method: Randomized, double blind, placebo controlled and multicenter clinical study.&#xD;
      Participants treatment for 48 weeks, and main aimed to evaluate the therapeutic effect of&#xD;
      tang wang prescription improve degree of retinal microvascular disease of patients with&#xD;
      diabetic non-proliferative retinopathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. This study is a randomized, double-blinded, placebo-controlled and multicenter clinical&#xD;
           trial on type 2 diabetic non-proliferative retinopathy to evaluate the therapeutic&#xD;
           effect of tang wang prescription.&#xD;
&#xD;
        2. Through the calculation of sample size, 384 participants with type 2 diabetic&#xD;
           non-proliferative retinopathy will be recruited for the study, all participants were&#xD;
           randomly divided into 2 groups, and both of groups would be performed on a basic&#xD;
           treatment (including diabetes education, diabetes diet, rational control of blood&#xD;
           glucose (oral hypoglycemic agents or insulin injections to keep all participants keep&#xD;
           blood glucose stable in the study. If fasting blood glucose fluctuates more than 20%,&#xD;
           need to find and remove the factors as soon as possible, and adjust the dose and monitor&#xD;
           change of blood glucose, make it smooth in 4 weeks. Adjusted dose of the drug needs to&#xD;
           be detailed records in the combined medication table), and oral calcium dobesilate&#xD;
           treatment), study group take tang wang prescription, take one bag each time and twice on&#xD;
           day, control group take the same dose of placebo.&#xD;
&#xD;
        3. The study will last for 48 weeks. Once every four weeks follow-up, color fundus&#xD;
           photography, fundus fluorescein angiography, and coherent optical tomography were&#xD;
           performed every six months; ETDRS international visual acuity test was performed every&#xD;
           months.&#xD;
&#xD;
        4. Curative effect evaluation criteria:&#xD;
&#xD;
             -  Main evaluation criteria: the changes of degree of retinal microvascular lesions&#xD;
                before and after treatment, according to the change of degree of retinal&#xD;
                microvascular lesions (no, mild non proliferative phase, moderate non proliferative&#xD;
                phase, severe non proliferative phase, proliferative phase), divided into&#xD;
                aggravated, unchanged, reduce three conditions. Aggravated was defined as the&#xD;
                degree of retinal microvascular lesions severity more than grade 1 after treatment;&#xD;
                unchanged was defined as the degree of retinal microvascular lesions before and&#xD;
                after treatment did not change; reduce was defined as the degree of retinal&#xD;
                microvascular lesions reduced more than 1 grade after treatment.&#xD;
&#xD;
             -  Second evaluation criteria:&#xD;
&#xD;
                  -  Change of the number of micro hemangioma of diabetic retinopathy before and&#xD;
                     after treatment;&#xD;
&#xD;
                  -  Change of the number of microvascular bleeding of diabetic retinopathy before&#xD;
                     and after treatment;&#xD;
&#xD;
                  -  Change of the number of microvascular leakage of diabetic retinopathy before&#xD;
                     and after treatment;&#xD;
&#xD;
                  -  Degree of change of macular edema of diabetic retinopathy before and after&#xD;
                     treatment;&#xD;
&#xD;
                  -  Change of Vision before and after treatment.&#xD;
&#xD;
        5. Diagnostic and monitoring indicators：blood pressure, fasting blood glucose test (every&#xD;
           one month); glycated hemoglobin, blood lipids (every three months); Routine eye&#xD;
           examination and fundus examination, including intraocular pressure, anterior segment,&#xD;
           lens, vitreous body, and lens, vitreous need describe the conditions of opacity (every&#xD;
           six months).&#xD;
&#xD;
        6. The provisions of the combined therapy&#xD;
&#xD;
             -  All Chinese herbal medicines with the same efficacy as the study drug (including&#xD;
                Chinese herbal medicines with similar therapeutic and similar efficacy in&#xD;
                Instructions) were banned during the study period.&#xD;
&#xD;
             -  All combined therapy and Combined medication(treatment measure or treatment&#xD;
                medicine of other diseases) should be recorded in the combined medication table.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2017</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">May 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the changes of degree of retinal microvascular lesions before and after treatment (no, mild non proliferative phase, moderate non proliferative phase, severe non proliferative phase, proliferative phase)</measure>
    <time_frame>0 week, 24 weeks, 48 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the number of micro hemangioma of diabetic retinopathy</measure>
    <time_frame>0 week, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the number of microvascular bleeding of diabetic retinopathy</measure>
    <time_frame>0 week, 24 weeks, 48 weeks</time_frame>
    <description>Color fundus photography and fundus fluorescein angiography were performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the number of microvascular leakage of diabetic retinopathy</measure>
    <time_frame>0 week, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of change of macular edema of diabetic retinopathy,analysis of measured values of the shortest distance from the margin of edema and the retinal thickness in macular region before and after medication</measure>
    <time_frame>0 week, 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Vision (analysis of visual acuity before and after medication using EDTRS international visual acuity chart)</measure>
    <time_frame>0 week, 4 weeks, 8 weeks,12 weeks,16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">384</enrollment>
  <condition>Diabetic Non-proliferative Retinopathy</condition>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Tangwang Prescription</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The prescription was composed five Chinese herbal medicines,every bag has 4.87g granules, 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>Placebo is a simulated drug of tangwang Prescription,every bag has 4.87g granules, take it one bag each time, two times a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tangwang prescription</intervention_name>
    <description>A kind of Granule(Tangwang prescription) was composition by five Chinese herbal medicines, every bag has 4.87g granules.</description>
    <arm_group_label>Tangwang Prescription</arm_group_label>
    <other_name>Tang Wang Fang</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is a simulated drug of tangwang prescription,included weight, appearance, colour, taste,smell and solubility.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebos</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of diabetic retinopathy、the degree of disease was non-proliferative diabetic&#xD;
             retinopathy；&#xD;
&#xD;
          2. Age at 30-70 years old；&#xD;
&#xD;
          3. Signed the informed consent；&#xD;
&#xD;
               -  Note: Diabetic retinopathy patients can be selected as the observation object,&#xD;
                  Who only one eye can meet the inclusion criteria, If both eyes of patient can be&#xD;
                  selected, please record respectively, and choose one eye to evaluate the curative&#xD;
                  effect, the eye must according to the following principles: choose the heavier&#xD;
                  eye as the observation eye, When the fundus conditions of the eyes are in&#xD;
                  different clinical stages; Select the eye as the eye of clinical manipulation.&#xD;
                  Choose the eyes with better clinical operation as the observation eyes, When the&#xD;
                  fundus conditions of the eyes are in same clinical stages.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patients with retinal photocoagulation、appropriate patients for retinal&#xD;
             photocoagulation、patient have one or two eyes in diabetic retinopathy proliferative&#xD;
             phase、type I diabetes mellitus、there are other eye disease complications(such as&#xD;
             glaucoma、cataracts can Significantly interfere the fundus examination、Non - diabetic&#xD;
             retinopathy、uveitis、amotio retinae、optic nerve diseases and high myopia with fundus&#xD;
             lesions et al.)&#xD;
&#xD;
          2. Combined with severe primary disease such as cardiovascular、liver、kidney and&#xD;
             hematopoietic system et al、the serum transaminase was 2 times larger than the normal&#xD;
             valuet、Serum creatinine greater than the upper limit of normal value、Psychiatric&#xD;
             patients.&#xD;
&#xD;
          3. Women with Pregnancy or prepare for pregnancy or lactating.&#xD;
&#xD;
          4. Patient participated in other clinical researchers within a month.&#xD;
&#xD;
          5. Patients have been treated with other drugs to treat diabetic retinopathy except for&#xD;
             calcium hydroxide within a week.&#xD;
&#xD;
          6. Systolic blood pressure &gt; 160mmHg or diastolic blood pressure &gt; 100mmHg.&#xD;
&#xD;
          7. Patients with diabetic ketosis, ketoacidosis and severe infections within a month&#xD;
&#xD;
          8. Patients have been alcohol abused and / or used psychoactive substances or drug abused&#xD;
             or drug addicted within 5 years.&#xD;
&#xD;
          9. According to the researcher's judgment, patients have Other lesions or conditions&#xD;
             maybe reduce the possibility of entering groups or make the groups complex,such as&#xD;
             working environment change frequently、Living environment is unstable what easy to&#xD;
             cause loss to follow-up.&#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>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Fengmei Lian</investigator_full_name>
    <investigator_title>Chief</investigator_title>
  </responsible_party>
  <keyword>tang wang prescription</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</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/NCT03025399
org study id: 2015Tangwang Prescription
nct id: NCT03025399
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study include 384 Participants with diabetic non-proliferative retinopathy

      Design Method: Randomized, double blind, placebo controlled and multicenter clinical study.
      Participants treatment for 48 weeks, and main aimed to evaluate the therapeutic effect of
      tang wang prescription improve degree of retinal microvascular disease of patients with
      diabetic non-proliferative retinopathy.
1. This study is a randomized, double-blinded, placebo-controlled and multicenter clinical
           trial on type 2 diabetic non-proliferative retinopathy to evaluate the therapeutic
           effect of tang wang prescription.

        2. Through the calculation of sample size, 384 participants with type 2 diabetic
           non-proliferative retinopathy will be recruited for the study, all participants were
           randomly divided into 2 groups, and both of groups would be performed on a basic
           treatment (including diabetes education, diabetes diet, rational control of blood
           glucose (oral hypoglycemic agents or insulin injections to keep all participants keep
           blood glucose stable in the study. If fasting blood glucose fluctuates more than 20%,
           need to find and remove the factors as soon as possible, and adjust the dose and monitor
           change of blood glucose, make it smooth in 4 weeks. Adjusted dose of the drug needs to
           be detailed records in the combined medication table), and oral calcium dobesilate
           treatment), study group take tang wang prescription, take one bag each time and twice on
           day, control group take the same dose of placebo.

        3. The study will last for 48 weeks. Once every four weeks follow-up, color fundus
           photography, fundus fluorescein angiography, and coherent optical tomography were
           performed every six months; ETDRS international visual acuity test was performed every
           months.

        4. Curative effect evaluation criteria:

             -  Main evaluation criteria: the changes of degree of retinal microvascular lesions
                before and after treatment, according to the change of degree of retinal
                microvascular lesions (no, mild non proliferative phase, moderate non proliferative
                phase, severe non proliferative phase, proliferative phase), divided into
                aggravated, unchanged, reduce three conditions. Aggravated was defined as the
                degree of retinal microvascular lesions severity more than grade 1 after treatment;
                unchanged was defined as the degree of retinal microvascular lesions before and
                after treatment did not change; reduce was defined as the degree of retinal
                microvascular lesions reduced more than 1 grade after treatment.

             -  Second evaluation criteria:

                  -  Change of the number of micro hemangioma of diabetic retinopathy before and
                     after treatment;

                  -  Change of the number of microvascular bleeding of diabetic retinopathy before
                     and after treatment;

                  -  Change of the number of microvascular leakage of diabetic retinopathy before
                     and after treatment;

                  -  Degree of change of macular edema of diabetic retinopathy before and after
                     treatment;

                  -  Change of Vision before and after treatment.

        5. Diagnostic and monitoring indicators：blood pressure, fasting blood glucose test (every
           one month); glycated hemoglobin, blood lipids (every three months); Routine eye
           examination and fundus examination, including intraocular pressure, anterior segment,
           lens, vitreous body, and lens, vitreous need describe the conditions of opacity (every
           six months).

        6. The provisions of the combined therapy

             -  All Chinese herbal medicines with the same efficacy as the study drug (including
                Chinese herbal medicines with similar therapeutic and similar efficacy in
                Instructions) were banned during the study period.

             -  All combined therapy and Combined medication(treatment measure or treatment
                medicine of other diseases) should be recorded in the combined medication table.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: the changes of degree of retinal microvascular lesions before and after treatment (no, mild non proliferative phase, moderate non proliferative phase, severe non proliferative phase, proliferative phase)
time frame: 0 week, 24 weeks, 48 weeks
measure: Change of the number of micro hemangioma of diabetic retinopathy
time frame: 0 week, 24 weeks, 48 weeks
measure: Change of the number of microvascular bleeding of diabetic retinopathy
time frame: 0 week, 24 weeks, 48 weeks
description: Color fundus photography and fundus fluorescein angiography were performed
measure: Change of the number of microvascular leakage of diabetic retinopathy
time frame: 0 week, 24 weeks, 48 weeks
measure: Degree of change of macular edema of diabetic retinopathy,analysis of measured values of the shortest distance from the margin of edema and the retinal thickness in macular region before and after medication
time frame: 0 week, 24 weeks, 48 weeks
measure: Change of Vision (analysis of visual acuity before and after medication using EDTRS international visual acuity chart)
time frame: 0 week, 4 weeks, 8 weeks,12 weeks,16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks
arm group label: Tangwang Prescription
arm group type: Experimental
description: The prescription was composed five Chinese herbal medicines,every bag has 4.87g granules, take it one bag each time, two times a day.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo is a simulated drug of tangwang Prescription,every bag has 4.87g granules, take it one bag each time, two times a day.
intervention type: Drug
intervention name: Tangwang prescription
description: A kind of Granule(Tangwang prescription) was composition by five Chinese herbal medicines, every bag has 4.87g granules.
arm group label: Tangwang Prescription
other name: Tang Wang Fang
intervention type: Drug
intervention name: Placebo
description: Placebo is a simulated drug of tangwang prescription,included weight, appearance, colour, taste,smell and solubility.
arm group label: Placebo
other name: Placebos
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
responsible party type: Sponsor-Investigator
investigator affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
investigator full name: Fengmei Lian
investigator title: Chief
mesh term: Retinal Diseases
sharing ipd: Undecided