Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Dosage-efficacy Relationship Clinical Trial of Ge Gen Qin Lian Decoction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01219803
• Other study ID #: 20100727
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2010
• Last updated: May 5, 2012
• Start date: August 2010
• Est. completion date: August 2014

Study information

• Verified date: May 2012
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Feng mei Lian, Ph.D
• Phone: 0086-010-88001402
• Email: melonzhao[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Ge Gen Qin Lian Decoction are one kind of Chinese prescription, and previous study showed they had antidiabetic effects on the clinical patients and no obvious toxicity was found. The purpose of this study was to evaluate the efficacy and safety of different dosage of Ge Gen Qin Lian Decoction in the treatment of type 2 diabetic patients and explore relationship of the dosage and effect and the safety of 3 dosages of Ge Gen Qin Lian Decoction.

Description:

two hundred and forty primary diabetic patients will be expected to be recruited, which were divided into different groups in a randomized, doubled blind, dose-paralleled-control multi-centre clinical design. The patients were randomly taken with high-dosage(5 times of low-dosage),mild-dosage(3 times of low-dosage), low-dosage,placebo(4.5% of low dosage) by 2 times every day for 12 weeks. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG),postprandial 2 hours plasma glucose(2hPG),insulin(0h,1h,2h),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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of type 2 diabetes mellitus

• 30-65 years old

• HbA1c=7.0%, and FPG>7.0 mmol/L, but <13.9 mmol/L or 2hPG>11.1 mmol/L

• Informed consent has been signed

• Dampness and Heat in Spleen

Exclusion Criteria:

• The patients accepted diabetic treatment for more than a month continuously

• The patients were treated by drugs in 3 week before they were given test drugs

• Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month

• The contractive pressure >160 mmHg or diastolic pressure >100 mmHg

• Pregnant, preparing for pregnancy or breast-feeding women

• Mental patients

• The patients whose ALT or AST are >100U/L,and BUN or Cr are abnormal.

• The patients who have serious heart, lung, liver, kidney and brain or other primary complications

• Allergic persons

• The patients who are attending other clinical trial

• The patients who have serious diabetic complications

• The patients who ever attended this clinical trial

• Alcohol and / or psychoactive substances, drug abuse and dependency

• The person maybe loss for some reason such as work or life condition according to the investigator's judgement

• The lipid-lowering or antihypertensive drug dosage and category which the patients are taking could not be kept stable

• The patients who are eating some drugs or health food which can affect the body weight

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dose-Response Relationship, Drug

Intervention

Drug:
• High Dose GGQL Decoction
The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc,5 times thick of low dose GGQL Decoction, 150ml/bag, twice in a day
• Mild dose GGQL Decoction
The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc,3 times thick of low dose GGQL Decoction, 150ml/bag, twice in a day
• Low dose GGQL Decoction
The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc, 150ml/bag, twice in a day
• Placebo
The placebo was a kind of decoction,which including 4.5% low dose GGQL Decoction to feel bitter taste as other drugs, 150ml/bag, twice in a day

Locations

Country	Name	City	State
China	Beijing Traditional Chinese Medicine Hospital of the Capital University of Medical Sciences	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Dongzhimen Hospital Attached to Beijing Traditional Chinese Medicine University	Beijing	Beijing
China	Ji Shui Tan Hospital of Beijing	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		12 weeks after treatment	No
Secondary	Fasting plasma glucose (FPG)?postprandial 2 hours plasma glucose(2hPG)		12 weeks after treatment	No
Secondary	blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests		12 weeks after treatment	Yes
Secondary	Ins(0h,1h,2h),blood lipids		12 weeks after treatment	No