Effects of Tianqi Capsule on Glucose Variability in Patients With Type 2 Diabetes.
NCT ID: NCT02617732
Last Updated: 2015-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-01-31
2018-02-28
Brief Summary
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Detailed Description
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Tianqi capsule(Chinese herbs extract) is a Chinese patent medicine approved to treat T2DM in China. Previous clinical studies have shown that Tianqi capsule could lower blood glucose measured by HbA1c. What's more, Tianqi capsule has also been proved to improve the glycometabolism and lipid metabolism in T2DM and IGT.
This research adopts a randomized, open, parallel double blind, placebo controlled clinical method. The patients, meeting eligibility criteria, are divided into experimental group and placebo group and treated for 12 weeks . A main outcome，glucose variability is detected by continuous blood glucose monitoring system which could obtain continuous and comprehensive blood glucose by "glucose sensor". The influence of Tianqi capsule on glucose variability in type 2 diabetes will be evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tianqi capsule
a Chinese patent medicine extracted form more than10 kinds of herbs, which was approved to treat type 2 diabetes by CDFA in 2002.
Tianqi capsule
The patients with type 2 diabetes are divided into two groups, one is experimental group, and the other is placebo group.
The experimental group patients are treated with Tianqi capsule by oral, 5 pills three times a day
placebo
a capsule looks the same as Tianqi capsule, containing starch and other edible compositions.
placebo
The patients with type 2 diabetes are divided into two groups, one is experimental group, the other is placebo group.
The placebo group patients are treated with placebo by oral, 5 pills three times a day
Interventions
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Tianqi capsule
The patients with type 2 diabetes are divided into two groups, one is experimental group, and the other is placebo group.
The experimental group patients are treated with Tianqi capsule by oral, 5 pills three times a day
placebo
The patients with type 2 diabetes are divided into two groups, one is experimental group, the other is placebo group.
The placebo group patients are treated with placebo by oral, 5 pills three times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* meet type 2 diabetes mellitus diagnostic criteria published by 1999 WHO;
* with blood variability, defined as standard deviation of blood glucose more than 3.5mmol／L within 2 days by self-monitoring of blood glucose（SMBG）(more than 5 times per day)
* diabetic duration more than 1 year; in stable condition for more than 4 weeks with unchanged lifestyle and other drugs intervention; （permit taking metformin or sulphonylureas which dosage is unchanged during study period ）
* HbA1c≤10％;
* signed the informed consent form.
Exclusion Criteria
* have severe chronic diabetes complications(e.g. diabetic retinopathy stage 4\~6,severe diabetic nephropathy needs dialysis and so on）
* have gastrointestinal disease which have serious influence on digestive function and disorder of absorption
* have other endocrine disease (hyperthyroidism,acromegaly,Cushing's syndrome and so on.)
* have severe heart disease(such as acute myocardium infarction, unstable angina,heart failure NYHA functional classification III or IV）
* have moderate or severe liver function abnormality(ALT,TBil or AST\> double upper limit )
* have moderate and severe renal function abnormality(eGFR \< 50ml／min)
* blood leukocyte \<4.0×10\^9/L; blood thrombocyte\<90×10\^9/L
* taking drugs affecting glucose metabolism,such as glucocorticoid
* have other serious illness which considered to exacerbate and be life-threaten during fellow up period;
* have evidence of mental disorders;
* alcoholics and drug abuse
* females who were pregnant, lactating, planning for pregnancy, or sexually active but with no contraceptive measures;
* have participated in clinical trials within 3 months before;
* other conditions researchers thought to unable to evaluate the curative effect and finish the study.
* allergic to the ingredients of herbs contained in Tianqi capsule
20 Years
80 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiaochun Liang, Doctor
Role: STUDY_DIRECTOR
Peking Union Medical College Hospital traditional Chinese medicine department
Locations
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Peking Union Medical College Hospital traditional Chinese medicine department
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PUMCH-TCM-TQGV-01
Identifier Type: -
Identifier Source: org_study_id