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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: Tang-min-ling pills high dosage; Drug: Tang-min-ling pills low dosage

• Registration Number: NCT01107171
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief 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.

Study Timeline

• Status Verified: 2008-05
• Study Start: 2008-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Last Update Submitted: 2010-04-20
• Last Update Posted: 2010-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Patients with primary type 2 diabetes mellitus
2. BMI ≥ 24 kg•m-2
3. 30-70 years old
4. HbA1c≥7.0%, and FPG>7.0 mmol/L, but <13.9 mmol/L or 2hPG>11.1 mmol/L
5. Informed consent has been signed
6. stagnated heat of liver and stomach syndrome according to TCM syndrome differentiation

Exclusion Criteria

1. The patients accepted diabetic treatment for more than a month continuously
2. The patients were treated by drugs in 3 week before they were given test drugs
3. Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month
4. The contractive pressure >160 mmHg or diastolic pressure >100 mmHg
5. Pregnant, preparing for pregnancy or breast-feeding women
6. Mental patients
7. The patients who have serious heart, lung, liver, kidney and brain or other primary complications
8. Allergic persons
9. The patients who are attending other clinical trial
10. The patients who have serious diabetic complications
11. The patients who ever attended this clinical trial
12. Alcohol and / or psychoactive substances, drug abuse and dependency
13. The person maybe loss for some reason such as work or life condition according to the investigator's judgement
14. The lipid-lowering or antihypertensive drug dosage and category which the patients are taking couldn't be kept stable
15. The patients who are eating some drugs or health food which can affect the body weight

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Tang-min Lin pills analogue
Tang-min-ling pills high dosage	Tang-min-ling pills high dosage	Tang-min-ling pills, high dosage, 12g, tid po
Tang-min-ling pills low dosage	Tang-min-ling pills low dosage	low dosage group:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c)	12 weeks after treatment	The HbA1c was measured and analyzed twice, one is before the treatment and the other is 12 weeks aftertreatment to make a self comparison.

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、body mass index (BMI)、waist circumference (WC)	12 weeks after treatment
The rate of adverse events,the blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests	12 weeks after treatment	The number of participants with adverse events were recorded and compared. The blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and observe the safety.
symptoms score and Chinese syndrome	12 weeks after treatment

Trial Locations

Locations (6)

Jilin Hospital of Integrated Traditional and Western Medicine; 🇨🇳 Changchun, China

The Affiliated Hospital to Liaoning University of Traditional Chinese Medicine; 🇨🇳 Shenyang, China

The Affiliated Hospital to Changchun University of Chinese Medicine; 🇨🇳 Changchun, China

Shanghai Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, China

The Second Affiliated Hospital to Liaoning University of TCM; 🇨🇳 Shenyang, China

First Teaching Hospital of Tianjin University of TCM; 🇨🇳 Tianjin, China