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

May 5, 2012 updated by: Tong Xiaolin, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Principal Investigator:
          • Yuan Xu, Ph.D
      • Beijing, Beijing, China, 100010
        • Recruiting
        • Beijing Traditional Chinese Medicine Hospital of the Capital University of Medical Sciences
        • Principal Investigator:
          • Bai Chang, Ph.D
      • Beijing, Beijing, China, 100035
        • Recruiting
        • Ji Shui Tan Hospital of Beijing
        • Principal Investigator:
          • Xia Wang, M.D
      • Beijing, Beijing, China, 100700
        • Recruiting
        • Dongzhimen Hospital Attached to Beijing Traditional Chinese Medicine University
        • Principal Investigator:
          • Hongfang Liu, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: 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
Other Names:
  • placebo of Ge-Gen-Qin-Lian Decoction
EXPERIMENTAL: High dose GGQL Decoction
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
Other Names:
  • High Dose Ge Gen Qin Lian Decoction
EXPERIMENTAL: Mild dose GGQL Decoction
Drug: 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
Other Names:
  • Mild dose Ge Gen Qin Lian Decoction
EXPERIMENTAL: Low dose GGQL Decoction
Drug: 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
Other Names:
  • Low dose Ge Gen Qin Lian Decoction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 12 weeks after treatment
12 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)
Time Frame: 12 weeks after treatment
12 weeks after treatment
blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests
Time Frame: 12 weeks after treatment
12 weeks after treatment
Ins(0h,1h,2h),blood lipids
Time Frame: 12 weeks after treatment
12 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

  • Study Chair: Xiao Lin Tong, Ph.D, Guang' anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2014

Study Completion (ANTICIPATED)

August 1, 2014

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (ESTIMATE)

October 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 5, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20100727

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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