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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01107171 |
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Date of registration:
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15/04/2010 |
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Primary sponsor: |
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Public title:
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Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes
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Scientific title:
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Multi-center Randomized Controled and Double Blind Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes |
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Date of first enrolment:
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May 2008 |
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Target sample size:
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210 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01107171 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Xiaolin Tong, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Guang Anmen Hospital of China Academy of Chinese Medical Sciences |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: Placebo
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Drug: Tang-min-ling pills high dosage
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Drug: Tang-min-ling pills low dosage
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Primary Outcome(s)
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Hemoglobin A1c (HbA1c)
[Time Frame: 12 weeks after treatment]
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Secondary Outcome(s)
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Fasting plasma glucose (FPG)?postprandial 2 hours plasma glucose(2hPG)?body mass index (BMI)?waist circumference (WC)
[Time Frame: 12 weeks after treatment]
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symptoms score and Chinese syndrome
[Time Frame: 12 weeks after treatment]
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The rate of adverse events,the blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests
[Time Frame: 12 weeks after treatment]
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Secondary ID(s)
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2008002P2A02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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