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More info
You can access this
clinical trial
if you have
Type 2 Diabetes Mellitus
and you are
between 30 and 70
years old
0
This is an early phase trial to investigate
how or whether the drug affects your body.
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The purpose

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.

Provided treatments

  • Drug: Tangbi (prescription)
  • Drug: Placebo

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03010241. The sponsor of the trial is Guang'anmen Hospital of China Academy of Chinese Medical Sciences and it is looking for 188 volunteers for the current phase.
Official trial title:
A Randomized, Multi-center, Double-blind, Placebo-controlled Trial of Traditional Chinese Medicine in the Treatment of Diabetes Distal Symmetric Polyneuropathy