<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/NCT03010241</url>
  </required_header>
  <id_info>
    <org_study_id>2016Tangbi Prescription</org_study_id>
    <nct_id>NCT03010241</nct_id>
  </id_info>
  <brief_title>The Multi-Centric Clinical Study of Chinese Medicine Intervention on Diabetes Distal Symmetric Polyneuropathy.</brief_title>
  <official_title>A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Traditional Chinese Medicine in the Treatment of Diabetes Distal Symmetric Polyneuropathy</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>First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Yiling Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hubei 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Distal symmetric polyneuropathy (DSPN) is the most common complication of type 2&#xD;
      diabetes mellitus (T2DM) and the most common form of peripheral neuropathy. DSPN increases&#xD;
      the risk of foot ulceration up to seven-fold, and is a significant risk factor in more than&#xD;
      60% of the amputations of the lower limbs in patients with T2DM. Reportedly, TCM may have&#xD;
      some advantages in relieving symptoms and reducing the incidence of DSPN exacerbations.We&#xD;
      postulate that patients with DSPN will benefit from therapy with TCM treatment according to&#xD;
      syndrome differentiation.&#xD;
&#xD;
      Methods and design: A randomized, double-blind, placebo-controlled and multi-centric clinical&#xD;
      trial design was used on the basis of a co-regimen of mecobalamin. Subjects who met the&#xD;
      inclusion criteria were randomly divided into two groups. The patients in the study group&#xD;
      were treated with Tangbi prescription, and the patients in the control group were treated&#xD;
      with placebo. Treatment was scheduled for 24 weeks. The sample size was 188 cases.Major&#xD;
      evaluation indicators: Changes in Clinical Symptoms and Signs in Distal Symmetrical&#xD;
      Polyneuropathy patients.The clinical symptoms and signs of patients were recorded by Michigan&#xD;
      Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS)&#xD;
      were compared between the two groups before and after medication. Secondary Evaluation&#xD;
      Indicators:① nerve conduction velocity changes, The changes in nerve conduction velocity of&#xD;
      each nerve were compared before and after taking medicine.② Clinical symptoms and signs&#xD;
      change, The clinical symptoms and signs of the patients were compared before and after taking&#xD;
      the medicine.&#xD;
&#xD;
      Discussion: We postulate that patients with DSPN will benefit from therapy with TCM&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Purpose of the study Major objective: To evaluate the efficacy of traditional Chinese&#xD;
           medicine (Tangbi prescription) in improving the clinical symptoms of patients with&#xD;
           diabetic distal symmetric polyneuropathy.&#xD;
&#xD;
           Secondary objective: To evaluate the effect of traditional Chinese medicine (Tangbi&#xD;
           prescription) on nerve conduction velocity of patients with diabetic distal symmetric&#xD;
           polyneuropathy.&#xD;
&#xD;
        2. Experimental Measures and contrast A randomized, double-blind, placebo-controlled and&#xD;
           multi-centric clinical trial design was used on the basis of a co-regimen of&#xD;
           mecobalamin. The patients in the study group were treated with Tangbi prescription (1&#xD;
           dose / day, twice), and patients were treated with placebo (1 dose / day, twice) in the&#xD;
           control group. Treatment was scheduled for 24 weeks. The sample size was determined to&#xD;
           188 cases through statistics calculation.&#xD;
&#xD;
           Sample size calculation basis: According to the preliminary study of Antang-tongbi&#xD;
           prescription data, placebo group scale (Toronto TCSS scale) score difference is 3.45,&#xD;
           while Tangbi prescription scale score was 4.14, and the public standard deviation s =&#xD;
           1.33. The sample size is estimated by hypothesis test formula of measurement data: N = 2&#xD;
           * [(Zα + Zβ) * δ / d] ^ 2 (pp. 112-113 of the third edition of Epidemiology) (n is the&#xD;
           sample size and σ is the estimated standard deviation, d is two groups' continuous&#xD;
           variable mean difference; Zα and Zβ are the corresponding standard normal differences;&#xD;
           for Zα and Zβ values, see the Human Health Edition, Epidemiology, Third Edition, page&#xD;
           73, Table 6.2). Supposing= 0.05, β = 0.10, according to one-sided check table, the&#xD;
           quantile Zα = 1.64485, Zβ = 0.84162, and put them into the formula, and result was n =&#xD;
           78.10. Therefore, each group needs 78 patients. Considering no more than 20% withdrawal&#xD;
           rate, the total number of cases is 188, of 94 cases in each group.&#xD;
&#xD;
        3. Bias analysis The evaluation index of this study is clinical symptoms, affected by many&#xD;
           factors. Although there are many ways in the treatment of oral drugs, but the exact&#xD;
           evidence of evidence-based medicine is not proved. Therefore, there is little factor&#xD;
           impacting of the biases of the evaluation results, concluding the following aspects: (1)&#xD;
           blood glucose levels. (2) existing treatment measures, (3) the conditions of EMG&#xD;
           determination.&#xD;
&#xD;
           These influencing factors are addressed as follows: (1) As for blood glucose levels&#xD;
           factor, a randomized, double-blind study design approach was used to ensure consistency&#xD;
           of the factor in the two groups. (2) subjects taking Methycobal can reduce the&#xD;
           psychological effect of patients on the efficacy of curative effect and increase patient&#xD;
           compliance. (3) Train EMG doctors consistently, and the EMG determination is fixed,&#xD;
           which forms the SOP of this study.&#xD;
&#xD;
        4. Research design 4.1 The design scheme A randomized, double-blind, placebo-controlled and&#xD;
           multi-centric clinical trial design was used on the basis of a co-regimen of&#xD;
           mecobalamin. Subjects who met the inclusion criteria were randomly divided into two&#xD;
           groups. The patients in the study group were treated with Antang-tongbi prescription,&#xD;
           and the patients in the control group were treated with placebo. Treatment was scheduled&#xD;
           for 24 weeks. The sample size was 188 cases.&#xD;
&#xD;
           4.2 Research Period Medication cycle is 24 weeks. 4.3 curative effect evaluation&#xD;
           criteria 4.3.1 Major evaluation indicators Changes in Clinical Symptoms and Signs in&#xD;
           Distal Symmetrical Polyneuropathy patients.&#xD;
&#xD;
           The clinical symptoms and signs of patients were recorded by Michigan Diabetic&#xD;
           Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were&#xD;
           compared between the two groups before and after medication.&#xD;
&#xD;
           4.3.2 Secondary Evaluation Indicators&#xD;
&#xD;
           ① nerve conduction velocity changes The changes in nerve conduction velocity of each&#xD;
           nerve were compared before and after taking medicine.&#xD;
&#xD;
           ② Clinical symptoms and signs change The clinical symptoms and signs of the patients&#xD;
           were compared before and after taking the medicine.&#xD;
&#xD;
           4.4 Curative effect observation indicators ① Nerve conduction velocity (every 6 months).&#xD;
&#xD;
             -  MDNS scale (every 3 months). 4.5 Observational Indicators&#xD;
&#xD;
                ① Background observation (0 weeks)&#xD;
&#xD;
                  1. Demographic data: gender, age, height, weight and so on.&#xD;
&#xD;
                  2. General clinical data: medical history, course of the disease, treatment&#xD;
                     history, combined disease and medication.&#xD;
&#xD;
             -  Diagnostic and monitoring indicators&#xD;
&#xD;
                  1. Blood pressure, fasting blood glucose test (every 1 month).&#xD;
&#xD;
                  2. Glycated hemoglobin, blood lipids (every 3 months). 4.6 Analysis of relevant&#xD;
                     measures are based on bias analysis 4.7 Basic treatment ① Diabetes education;&#xD;
&#xD;
             -  Diabetic diet;&#xD;
&#xD;
                  -  Rational control of blood glucose: use oral hypoglycemic agents or insulin&#xD;
                     injections to keep all patients blood glucose stable in the study. In&#xD;
                     principle, the type and dose of hypoglycemic agents should maintain unchanged.&#xD;
                     If fasting blood glucose fluctuates more than 20%, diabetes experts were&#xD;
                     needed to find and remove the predisposing factors as soon as possible, and&#xD;
                     adjust the dose and monitor blood glucose changes, so the blood glucose can be&#xD;
                     smooth in 4 weeks. Adjusted dose of the drug needs to be detailed records in&#xD;
                     the combined medication table.&#xD;
&#xD;
                     ④ Taking Mecobalamin tablets (1 / time, 3 times / day). (Eisai (China)&#xD;
                     Pharmaceutical Co., Ltd.) 4.8 Provisions for combined treatment&#xD;
&#xD;
                       1. All Chinese herbal medicines with the same efficacy as the study drug&#xD;
                          (including Chinese herbal medicines with similar therapeutic indications&#xD;
                          and Chinese herbal medicines with similar efficacy) were banned during&#xD;
                          the study period.&#xD;
&#xD;
                       2. All combination therapy and treatment (treatment measure or treatment&#xD;
                          medicine of other diseases) should be documented in the combined&#xD;
                          medication table.&#xD;
&#xD;
                  -  Besides Methycobal, drugs for the treatment of diabetic peripheral neuropathy&#xD;
                     are prohibited, including α-lipoic acid, epalrestat, VitB12 and so on.&#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">November 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>The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication</measure>
    <time_frame>Month 0, Month 3, Month 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>nerve conduction velocity changes The changes in nerve conduction velocity of each nerve were compared before and after taking medicine.</measure>
    <time_frame>Month 0, Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical symptoms and signs change The clinical symptoms and signs of the patients were compared before and after taking the medicine.</measure>
    <time_frame>Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">188</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Tangbi Prescription</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Based on the standard medical care, experimental group were treated with Tangbi Prescription 4.87g granules, 2 times/d, which The prescripton was composed by five Chinese herbal medicines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Based on the standard medical care, placebo-controlled group were treated with Placebo 4.87g granules, 2 times/d</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tangbi (prescription)</intervention_name>
    <description>A kind of Granule(Tang bi fang) was made from five kind of Chinese herbs. Other: Standard medical care Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).</description>
    <arm_group_label>Tangbi Prescription</arm_group_label>
    <other_name>Tang bi fang</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Granule(Placebo) is in accordance with Tangbi prescription in appearance, colour, taste.&#xD;
Other: Standard medical care. Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebos</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meet the diagnostic criteria of diabetic distal symmetric polyneuropathy;&#xD;
&#xD;
          2. The patient's age is between 30-70 years;&#xD;
&#xD;
          3. Sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Recent use of antioxidants such as vitamin E or vitamin C, acute infection, liver and&#xD;
             kidney dysfunction, acute complications of diabetes, severe cardiovascular and&#xD;
             cerebrovascular diseases, neuropathy caused by long-term alcohol consumption and other&#xD;
             factors.&#xD;
&#xD;
          2. Combined with cardiovascular, liver, kidney and hematopoietic system and other serious&#xD;
             primary disease, serum transaminase beyond the normal value more than 2 times, serum&#xD;
             creatinine greater than the upper limit of normal, psychiatric patients.&#xD;
&#xD;
          3. Pregnancy, prepared to pregnant or lactating women, or having a history of drug&#xD;
             allergy.&#xD;
&#xD;
          4. Participate in other drug clinical within one month.&#xD;
&#xD;
          5. Systolic blood pressure&gt; 160mmHg or diastolic blood pressure&gt; 100mmHg.&#xD;
&#xD;
          6. Having the diabetic ketoacidosis, ketoacidosis and severe infection within one month.&#xD;
&#xD;
          7. Drinking alcohol excessive and/or taking psychoactive substances, drug abusers and&#xD;
             dependents over the past five years.&#xD;
&#xD;
          8. Having other diseases or conditions may reduce the possibility of entry or complicate&#xD;
             the entry according to the researchers' judgement, such as the working environment&#xD;
             changes frequently, unstable living environment etc., what is easy to cause loss of&#xD;
             contact.&#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>De JIN, Master</last_name>
    <phone>13681514368</phone>
    <email>826901274@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fengmei Lian, PHD</last_name>
    <phone>0086-010-88001402</phone>
    <email>lfm565@sohu.com</email>
  </overall_contact_backup>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 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>PHD</investigator_title>
  </responsible_party>
  <keyword>Diabetes Distal Symmetric Polyneuropathy</keyword>
  <keyword>Chinese medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyneuropathies</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03010241
org study id: 2016Tangbi Prescription
nct id: NCT03010241
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Background: Distal symmetric polyneuropathy (DSPN) is the most common complication of type 2
      diabetes mellitus (T2DM) and the most common form of peripheral neuropathy. DSPN increases
      the risk of foot ulceration up to seven-fold, and is a significant risk factor in more than
      60% of the amputations of the lower limbs in patients with T2DM. Reportedly, TCM may have
      some advantages in relieving symptoms and reducing the incidence of DSPN exacerbations.We
      postulate that patients with DSPN will benefit from therapy with TCM treatment according to
      syndrome differentiation.

      Methods and design: A randomized, double-blind, placebo-controlled and multi-centric clinical
      trial design was used on the basis of a co-regimen of mecobalamin. Subjects who met the
      inclusion criteria were randomly divided into two groups. The patients in the study group
      were treated with Tangbi prescription, and the patients in the control group were treated
      with placebo. Treatment was scheduled for 24 weeks. The sample size was 188 cases.Major
      evaluation indicators: Changes in Clinical Symptoms and Signs in Distal Symmetrical
      Polyneuropathy patients.The clinical symptoms and signs of patients were recorded by Michigan
      Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS)
      were compared between the two groups before and after medication. Secondary Evaluation
      Indicators:① nerve conduction velocity changes, The changes in nerve conduction velocity of
      each nerve were compared before and after taking medicine.② Clinical symptoms and signs
      change, The clinical symptoms and signs of the patients were compared before and after taking
      the medicine.

      Discussion: We postulate that patients with DSPN will benefit from therapy with TCM
      treatment.
1. Purpose of the study Major objective: To evaluate the efficacy of traditional Chinese
           medicine (Tangbi prescription) in improving the clinical symptoms of patients with
           diabetic distal symmetric polyneuropathy.

           Secondary objective: To evaluate the effect of traditional Chinese medicine (Tangbi
           prescription) on nerve conduction velocity of patients with diabetic distal symmetric
           polyneuropathy.

        2. Experimental Measures and contrast A randomized, double-blind, placebo-controlled and
           multi-centric clinical trial design was used on the basis of a co-regimen of
           mecobalamin. The patients in the study group were treated with Tangbi prescription (1
           dose / day, twice), and patients were treated with placebo (1 dose / day, twice) in the
           control group. Treatment was scheduled for 24 weeks. The sample size was determined to
           188 cases through statistics calculation.

           Sample size calculation basis: According to the preliminary study of Antang-tongbi
           prescription data, placebo group scale (Toronto TCSS scale) score difference is 3.45,
           while Tangbi prescription scale score was 4.14, and the public standard deviation s =
           1.33. The sample size is estimated by hypothesis test formula of measurement data: N = 2
           * [(Zα + Zβ) * δ / d] ^ 2 (pp. 112-113 of the third edition of Epidemiology) (n is the
           sample size and σ is the estimated standard deviation, d is two groups' continuous
           variable mean difference; Zα and Zβ are the corresponding standard normal differences;
           for Zα and Zβ values, see the Human Health Edition, Epidemiology, Third Edition, page
           73, Table 6.2). Supposing= 0.05, β = 0.10, according to one-sided check table, the
           quantile Zα = 1.64485, Zβ = 0.84162, and put them into the formula, and result was n =
           78.10. Therefore, each group needs 78 patients. Considering no more than 20% withdrawal
           rate, the total number of cases is 188, of 94 cases in each group.

        3. Bias analysis The evaluation index of this study is clinical symptoms, affected by many
           factors. Although there are many ways in the treatment of oral drugs, but the exact
           evidence of evidence-based medicine is not proved. Therefore, there is little factor
           impacting of the biases of the evaluation results, concluding the following aspects: (1)
           blood glucose levels. (2) existing treatment measures, (3) the conditions of EMG
           determination.

           These influencing factors are addressed as follows: (1) As for blood glucose levels
           factor, a randomized, double-blind study design approach was used to ensure consistency
           of the factor in the two groups. (2) subjects taking Methycobal can reduce the
           psychological effect of patients on the efficacy of curative effect and increase patient
           compliance. (3) Train EMG doctors consistently, and the EMG determination is fixed,
           which forms the SOP of this study.

        4. Research design 4.1 The design scheme A randomized, double-blind, placebo-controlled and
           multi-centric clinical trial design was used on the basis of a co-regimen of
           mecobalamin. Subjects who met the inclusion criteria were randomly divided into two
           groups. The patients in the study group were treated with Antang-tongbi prescription,
           and the patients in the control group were treated with placebo. Treatment was scheduled
           for 24 weeks. The sample size was 188 cases.

           4.2 Research Period Medication cycle is 24 weeks. 4.3 curative effect evaluation
           criteria 4.3.1 Major evaluation indicators Changes in Clinical Symptoms and Signs in
           Distal Symmetrical Polyneuropathy patients.

           The clinical symptoms and signs of patients were recorded by Michigan Diabetic
           Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were
           compared between the two groups before and after medication.

           4.3.2 Secondary Evaluation Indicators

           ① nerve conduction velocity changes The changes in nerve conduction velocity of each
           nerve were compared before and after taking medicine.

           ② Clinical symptoms and signs change The clinical symptoms and signs of the patients
           were compared before and after taking the medicine.

           4.4 Curative effect observation indicators ① Nerve conduction velocity (every 6 months).

             -  MDNS scale (every 3 months). 4.5 Observational Indicators

                ① Background observation (0 weeks)

                  1. Demographic data: gender, age, height, weight and so on.

                  2. General clinical data: medical history, course of the disease, treatment
                     history, combined disease and medication.

             -  Diagnostic and monitoring indicators

                  1. Blood pressure, fasting blood glucose test (every 1 month).

                  2. Glycated hemoglobin, blood lipids (every 3 months). 4.6 Analysis of relevant
                     measures are based on bias analysis 4.7 Basic treatment ① Diabetes education;

             -  Diabetic diet;

                  -  Rational control of blood glucose: use oral hypoglycemic agents or insulin
                     injections to keep all patients blood glucose stable in the study. In
                     principle, the type and dose of hypoglycemic agents should maintain unchanged.
                     If fasting blood glucose fluctuates more than 20%, diabetes experts were
                     needed to find and remove the predisposing factors as soon as possible, and
                     adjust the dose and monitor blood glucose changes, so the blood glucose can be
                     smooth in 4 weeks. Adjusted dose of the drug needs to be detailed records in
                     the combined medication table.

                     ④ Taking Mecobalamin tablets (1 / time, 3 times / day). (Eisai (China)
                     Pharmaceutical Co., Ltd.) 4.8 Provisions for combined treatment

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

                       2. All combination therapy and treatment (treatment measure or treatment
                          medicine of other diseases) should be documented in the combined
                          medication table.

                  -  Besides Methycobal, drugs for the treatment of diabetic peripheral neuropathy
                     are prohibited, including α-lipoic acid, epalrestat, VitB12 and so on.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The clinical symptoms and signs of patients were recorded by Michigan Diabetic Neuropathy Score(MDNS), and the changes of Michigan Diabetic Neuropathy Score(MDNS) were compared between the two groups before and after medication
time frame: Month 0, Month 3, Month 6
measure: nerve conduction velocity changes The changes in nerve conduction velocity of each nerve were compared before and after taking medicine.
time frame: Month 0, Month 6
measure: Clinical symptoms and signs change The clinical symptoms and signs of the patients were compared before and after taking the medicine.
time frame: Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
arm group label: Tangbi Prescription
arm group type: Experimental
description: Based on the standard medical care, experimental group were treated with Tangbi Prescription 4.87g granules, 2 times/d, which The prescripton was composed by five Chinese herbal medicines.
arm group label: Placebo
arm group type: Placebo Comparator
description: Based on the standard medical care, placebo-controlled group were treated with Placebo 4.87g granules, 2 times/d
intervention type: Drug
intervention name: Tangbi (prescription)
description: A kind of Granule(Tang bi fang) was made from five kind of Chinese herbs. Other: Standard medical care Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).
arm group label: Tangbi Prescription
other name: Tang bi fang
intervention type: Drug
intervention name: Placebo
description: Granule(Placebo) is in accordance with Tangbi prescription in appearance, colour, taste.
Other: Standard medical care. Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).
arm group label: Placebo
other name: Placebos
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: De JIN, Master
phone: 13681514368
email: 826901274@qq.com
last name: Fengmei Lian, PHD
phone: 0086-010-88001402
email: lfm565@sohu.com
responsible party type: Principal Investigator
investigator affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
investigator full name: Lian-fengmei
investigator title: PHD
mesh term: Polyneuropathies
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided