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A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis) (XB)

Primary Purpose

Diabetic Peripheral Neuropathy, Diabetes, Chinese Herbs

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Xuebi formula
placebo
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • according to the 1999 WHO criteria, in accordance with the diagnostic criteria for type 2 diabetes.
  • according to the diagnostic standard of diabetes peripheral nerve lesions.
  • age range 30-70 years.
  • Syndrome of traditional Chinese medicine is Qi deficiency and blood stasis.
  • FBG < 13.9mmol/L, HbA1c<10%.
  • signed the informed consent

Exclusion Criteria:

  • did not meet the inclusion criteria, or incomplete information affect the clinical syndrome differentiation type;
  • repeated hypoglycemia reaction, nearly a month diabetic ketoacidosis, DKAand severe infections;
  • blood pressure without control or after control, SBP ≥ 160mmHg or (and)DBP ≥ 100mmHg;
  • TG≥ 5.6mmol / L;
  • diabetic lower extremity vascular disease (resting ankle brachial index in patients with ABI ≤ 0.90 or lower extremity ultrasound vascular stenosis > 50%).
  • pregnancy, to pregnant or lactating women;
  • the ingredients allergy of Chinese herbal medicine and allergic constitution person;
  • psychiatric patients;
  • have serious heart, lung, liver, kidney, brain and other complications overassociated with other severe primary diseases;
  • other patients had participated in clinical trials or are in other clinical trials before the test in January;
  • in the past 5 years with alcohol and / or psychoactive substances, drug abuse and dependence;
  • according to the researcher's judgment, can reduce the possibility of the group or other diseases or conditions were complicated, such as work environment change frequently, the living environment is not stable, easy to cause lost
  • hepatic, renal impairment (ALT, AST is greater than 2.5 times the upper limit of normal value; serum creatinine greater than 1.5 times the upper limit of normal value);
  • demyelinating lesions or from other causes of polyneuropathy patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Xuebi formula

    Placebo

    Arm Description

    Xuebi formula , one dosage ,every day, treat 6 months.

    placebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months.

    Outcomes

    Primary Outcome Measures

    Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS)
    Scores of TCM clinical symptom. Using statistical table score, main symptoms and secondary symptoms according to the degree is divided into light, medium, heavy, the main symptoms were recorded 2, 4, 6 points, the secondary symptoms were recorded 1, 2, 3 points. No symptomatic record 0 points. Before the study, of 4, 8, 12, 16, 20, 24 week each recorded 1 times. Description of tongue and pulse only, not scoring. the clinical scoring system of Toronto (TCSS). TCSS includes a score of neural symptoms, nerve reflex scores and sensory examination , a total of 19 points.Before the study, of 4, 8, 12, 16, 20, 24 week each scoring 1 times.According to the classification standard, 0-5 points does not have DPN, 6-8 points for mild DPN, 9-11 points for moderate DPN, 12-19 points for severe DPN.

    Secondary Outcome Measures

    Change in Nerve conduction velocity
    Nerve conduction velocity are recorded at 0,12th,24th weeks.

    Full Information

    First Posted
    December 8, 2013
    Last Updated
    January 15, 2014
    Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02039544
    Brief Title
    A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis)
    Acronym
    XB
    Official Title
    A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2015 (Anticipated)
    Study Completion Date
    May 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A Randomized, Parallel-controlled, Clinical Study to Evaluate the Efficacy of Xuebi Prescription Compared With Placebo in the Treatment of Diabetic Peripheral Neuropathy(Qi Deficiency and Blood Stasis)
    Detailed Description
    Charged by the sponsor in line with traditional Chinese medicine Qi deficiency and blood stasis syndrome 60 cases have DPN，they were randomly divided into Chinese herbal compound Xuebi prescription group and placebo group. The treatment groups were compared 24-week composite score.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Peripheral Neuropathy, Diabetes, Chinese Herbs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Xuebi formula
    Arm Type
    Experimental
    Arm Description
    Xuebi formula , one dosage ,every day, treat 6 months.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo,has the same taste and color as Xuebi formula one dosage ,every day, treat 6 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Xuebi formula
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    Change in Scores of TCM clinical symptom and the clinical scoring system of Toronto (TCSS)
    Description
    Scores of TCM clinical symptom. Using statistical table score, main symptoms and secondary symptoms according to the degree is divided into light, medium, heavy, the main symptoms were recorded 2, 4, 6 points, the secondary symptoms were recorded 1, 2, 3 points. No symptomatic record 0 points. Before the study, of 4, 8, 12, 16, 20, 24 week each recorded 1 times. Description of tongue and pulse only, not scoring. the clinical scoring system of Toronto (TCSS). TCSS includes a score of neural symptoms, nerve reflex scores and sensory examination , a total of 19 points.Before the study, of 4, 8, 12, 16, 20, 24 week each scoring 1 times.According to the classification standard, 0-5 points does not have DPN, 6-8 points for mild DPN, 9-11 points for moderate DPN, 12-19 points for severe DPN.
    Time Frame
    24weeks
    Secondary Outcome Measure Information:
    Title
    Change in Nerve conduction velocity
    Description
    Nerve conduction velocity are recorded at 0,12th,24th weeks.
    Time Frame
    24Weeks
    Other Pre-specified Outcome Measures:
    Title
    Number of participants with adverse events
    Description
    Adverse events with records at any time.
    Time Frame
    24Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    according to the 1999 WHO criteria, in accordance with the diagnostic criteria for type 2 diabetes. according to the diagnostic standard of diabetes peripheral nerve lesions. age range 30-70 years. Syndrome of traditional Chinese medicine is Qi deficiency and blood stasis. FBG < 13.9mmol/L, HbA1c<10%. signed the informed consent Exclusion Criteria: did not meet the inclusion criteria, or incomplete information affect the clinical syndrome differentiation type; repeated hypoglycemia reaction, nearly a month diabetic ketoacidosis, DKAand severe infections; blood pressure without control or after control, SBP ≥ 160mmHg or (and)DBP ≥ 100mmHg; TG≥ 5.6mmol / L; diabetic lower extremity vascular disease (resting ankle brachial index in patients with ABI ≤ 0.90 or lower extremity ultrasound vascular stenosis > 50%). pregnancy, to pregnant or lactating women; the ingredients allergy of Chinese herbal medicine and allergic constitution person; psychiatric patients; have serious heart, lung, liver, kidney, brain and other complications overassociated with other severe primary diseases; other patients had participated in clinical trials or are in other clinical trials before the test in January; in the past 5 years with alcohol and / or psychoactive substances, drug abuse and dependence; according to the researcher's judgment, can reduce the possibility of the group or other diseases or conditions were complicated, such as work environment change frequently, the living environment is not stable, easy to cause lost hepatic, renal impairment (ALT, AST is greater than 2.5 times the upper limit of normal value; serum creatinine greater than 1.5 times the upper limit of normal value); demyelinating lesions or from other causes of polyneuropathy patients.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    qiang zhou, PHD
    Phone
    15101016416
    Ext
    0086
    Email
    15101016416@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiaolin Tong, PHD
    Organizational Affiliation
    Guang'anmen Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    A Study of Xuebi Formula for Diabetic Peripheral Neuropathy(Qi-deficiency and Blood-stasis)

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