Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes
Dosage-efficacy Relationship Clinical Trial of Ge Gen Qin Lian Decoction
1 other identifier
interventional
240
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Aug 2010
Longer than P75 for not_applicable diabetes-mellitus-type-2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 12, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedMay 8, 2012
May 1, 2012
4 years
October 12, 2010
May 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
12 weeks after treatment
Secondary Outcomes (3)
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)
12 weeks after treatment
blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests
12 weeks after treatment
Ins(0h,1h,2h),blood lipids
12 weeks after treatment
Study Arms (4)
High dose GGQL Decoction
EXPERIMENTALMild dose GGQL Decoction
EXPERIMENTALLow dose GGQL Decoction
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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
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
The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc, 150ml/bag, twice in a day
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
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of type 2 diabetes mellitus
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Beijing Traditional Chinese Medicine Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality, 100010, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Ji Shui Tan Hospital of Beijing
Beijing, Beijing Municipality, 100035, China
Dongzhimen Hospital Attached to Beijing Traditional Chinese Medicine University
Beijing, Beijing Municipality, 100700, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiao Lin Tong, Ph.D
Guang' anmen Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 12, 2010
First Posted
October 13, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
May 8, 2012
Record last verified: 2012-05