Diabetes Mellitus, Type 2NCT01219803
Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes
A study testing High Dose GGQL Decoction, Mild dose GGQL Decoction and Low dose GGQL Decoction in people with Diabetes Mellitus, Type 2 and Dose-Response Relationship, Drug, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug
- What is being tested?
- High Dose GGQL Decoction, Mild dose GGQL Decoction and Low dose GGQL Decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 4 sitesChina
- Study dates
- Aug 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Beijing Traditional Chinese Medicine Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality, 100010
Bai Chang, Ph.D
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Yuan Xu, Ph.D
- Recruiting
Ji Shui Tan Hospital of Beijing
Beijing, Beijing Municipality, 100035
Xia Wang, M.D
- Recruiting
Dongzhimen Hospital Attached to Beijing Traditional Chinese Medicine University
Beijing, Beijing Municipality, 100700
Hongfang Liu, Ph.D
About this study
Official title: 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.
Read the 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.
- Being tested
- High Dose GGQL Decoction, Mild dose GGQL Decoction, Low dose GGQL Decoction, Placebo
- Keywords
- Dose-Response Relationship, type 2 diabetes,TCM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose GGQL DecoctionDrug
Also called High Dose Ge Gen Qin Lian 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 DecoctionDrug
Also called Mild dose Ge Gen Qin Lian 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 DecoctionDrug
Also called Low dose Ge Gen Qin Lian Decoction
The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc, 150ml/bag, twice in a day
PlaceboDrug
Also called placebo of Ge-Gen-Qin-Lian Decoction
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
| Study group | Role | What they receive |
|---|---|---|
| High dose GGQL Decoction | Experimental | Not described Receives: Drug: High Dose GGQL Decoction |
| Mild dose GGQL Decoction | Experimental | Not described Receives: Drug: Mild dose GGQL Decoction |
| Low dose GGQL Decoction | Experimental | Not described Receives: Drug: Low dose GGQL Decoction |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 12 weeks after treatment
Secondary outcomes (3)
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)
Measured: 12 weeks after treatment
blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests
Measured: 12 weeks after treatment
Ins(0h,1h,2h),blood lipids
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tong Xiaolin, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Xiao Lin Tong, Ph.D, Study chair, Guang' anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219803
- Sponsor's protocol ID
- 20100727
- Status last verified
- May 2012
- First submitted
- 12 Oct 2010
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosage-efficacy Relationship Clinical Trial of Ge Gen Qin Lian Decoction
- ClinicalTrials.gov ID
- NCT01219803
- Acronym / sponsor ID
- 20100727
- Keywords
- Dose-Response Relationship, type 2 diabetes,TCM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High dose GGQL Decoction | Experimental | Drug: High Dose GGQL Decoction |
| Mild dose GGQL Decoction | Experimental | Drug: Mild dose GGQL Decoction |
| Low dose GGQL Decoction | Experimental | Drug: Low dose GGQL Decoction |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Dose GGQL DecoctionAlso: High Dose Ge Gen Qin Lian DecoctionThe 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 | Drug | High dose GGQL Decoction |
| Mild dose GGQL DecoctionAlso: Mild dose Ge Gen Qin Lian DecoctionThe 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 | Drug | Mild dose GGQL Decoction |
| Low dose GGQL DecoctionAlso: Low dose Ge Gen Qin Lian DecoctionThe drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc, 150ml/bag, twice in a day | Drug | Low dose GGQL Decoction |
| PlaceboAlso: placebo of Ge-Gen-Qin-Lian DecoctionThe 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 | Drug | Placebo |
Primary outcome
HbA1c
Time frame: 12 weeks after treatment
3 secondary outcomes
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)
Time frame: 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
Ins(0h,1h,2h),blood lipids
Time frame: 12 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao Lin Tong, Ph.D study chair
Guang' anmen Hospital of China Academy of Chinese Medical Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Dose GGQL Decoction, Mild dose GGQL Decoction and Low dose GGQL Decoction in people with Diabetes Mellitus, Type 2 and Dose-Response Relationship, Drug, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng mei Lian, Ph.D (0086-010-88001402, melonzhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012.