NCT01107171

Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes

Multi-center Randomized Controled and Double Blind Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Tang-min-ling pills are made by Chinese herbs extract, and data showed they had antidiabetic effects on the experimental rats and no obvious toxicity was found.This is a randomized, doubled blind, dose-paralleled-control multi-centre clinical trial to evaluate the efficacy and safety of Tang-min-ling pills in the treatment of type 2 diabetic patients and explore the optimal dosage of Tang-min-ling pills.

Detailed description

Two hundred and ten of overweight patients inflicted with primary diabetes mellitus who had stagnated heat of liver and stomach syndrome were recruited, which were randomly divided into 3 groups, and were given high-dosage (12g Tang-min-ling pills every time), low-dosage (6g Tang-min-ling pills every time)、placebo by 3 times every day for 12 weeks respectively. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、syndrome、symptoms、body mass index (BMI)、waist circumference (WC) of these groups were measured and analyzed. Some safety indexes such blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and analyzed during the experiment. The treatment period is 12 week.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Tang-min-ling pills low dosage	low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
DRUG	Tang-min-ling pills high dosage	high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
DRUG	Placebo	Tang-min-Ling pills analogue 6g,tid,po

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2010-04-20
• Last updated: 2010-04-21

Locations

6 sites across 1 country: China