The Multi-Centric Clinical Study of Chinese Medicine Intervention on Diabetes Distal Symmetric Polyneuropathy.
A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Traditional Chinese Medicine in the Treatment of Diabetes Distal Symmetric Polyneuropathy
1 other identifier
interventional
188
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 type-2-diabetes-mellitus
Started Jan 2017
Longer than P75 for early_phase_1 type-2-diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJanuary 5, 2017
January 1, 2017
2.8 years
January 2, 2017
January 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Month 0, Month 3, Month 6
Secondary Outcomes (2)
nerve conduction velocity changes The changes in nerve conduction velocity of each nerve were compared before and after taking medicine.
Month 0, Month 6
Clinical symptoms and signs change The clinical symptoms and signs of the patients were compared before and after taking the medicine.
Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Study Arms (2)
Tangbi Prescription
EXPERIMENTALBased 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.
Placebo
PLACEBO COMPARATORBased on the standard medical care, placebo-controlled group were treated with Placebo 4.87g granules, 2 times/d
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- Meet the diagnostic criteria of diabetic distal symmetric polyneuropathy;
- The patient's age is between 30-70 years;
- Sign informed consent
You may not qualify if:
- Recent use of antioxidants such as vitamin E or vitamin C, acute infection, liver and kidney dysfunction, acute complications of diabetes, severe cardiovascular and cerebrovascular diseases, neuropathy caused by long-term alcohol consumption and other factors.
- Combined with cardiovascular, liver, kidney and hematopoietic system and other serious primary disease, serum transaminase beyond the normal value more than 2 times, serum creatinine greater than the upper limit of normal, psychiatric patients.
- Pregnancy, prepared to pregnant or lactating women, or having a history of drug allergy.
- Participate in other drug clinical within one month.
- Systolic blood pressure\> 160mmHg or diastolic blood pressure\> 100mmHg.
- Having the diabetic ketoacidosis, ketoacidosis and severe infection within one month.
- Drinking alcohol excessive and/or taking psychoactive substances, drug abusers and dependents over the past five years.
- Having other diseases or conditions may reduce the possibility of entry or complicate the entry according to the researchers' judgement, such as the working environment changes frequently, unstable living environment etc., what is easy to cause loss of contact.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Scienceslead
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicinecollaborator
- Zhengzhou City Hospital of Traditional Chinese Medicinecollaborator
- Affiliated Hospital of Liaoning University of Traditional Chinese Medicinecollaborator
- Hebei Yiling Hospitalcollaborator
- Hubei Hospital of Traditional Chinese Medicinecollaborator
Related Publications (1)
Jin D, Huang WJ, Meng X, Yang F, Zheng YJ, Bao Q, Zhang MZ, Yang YN, Ni Q, Lian FM, Tong XL. Chinese herbal medicine TangBi Formula treatment of patients with type 2 diabetic distal symmetric polyneuropathy disease: study protocol for a randomized controlled trial. Trials. 2017 Dec 29;18(1):631. doi: 10.1186/s13063-017-2345-1.
PMID: 29284520DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD
Study Record Dates
First Submitted
January 2, 2017
First Posted
January 5, 2017
Study Start
January 1, 2017
Primary Completion
November 1, 2019
Study Completion
May 1, 2020
Last Updated
January 5, 2017
Record last verified: 2017-01