Xinju Xiaogao Prescription Study on Overweight

Study Overview
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Brief Summary
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Xinju Xiaogao prescription and 10% of it in the treatment of adiposity (stagnation of QI causing phlegm retention)clinical study

Detailed Description
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Charged by the three research centers in line with traditional Chinese medicine stagnation of QI causing phlegm retention 120 cases have diabetes were randomly divided into Chinese herbal compound Xinju Xiaogao prescription group and 10% of the prescription group.The treatment groups were compared 24-week step-down and regulation of body weight,waistline, blood lipids, blood sugar effect.

Official Title
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Xinju Xiaogao Prescription and 10% of it in the Treatment of Adiposity (Stagnation of QI Causing Phlegm Retention)Clinical Study

Conditions
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Overweight

Intervention / Treatment
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* Drug: Xinju Xiaogao Prescription
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-60 years old BMI≥28kg/m2，but<40kg/m2 Waistline≥85cm（male）,≥80cm（female） Pathoglycemia must fulfill one of those four condition: IGT,7.8≤2hPG≤11.0mmol/, diabetics take medicine used to treat type 2 diabetes more than 3 month,and 5.6≤FBG≤12.2,and weight change under 4kg. stagnation of QI causing phlegm retention To sign informed consent. Exclusion Criteria: After 3-6 months simply controlling their diet and more exercise treatment, body weight weight loss ≥ 5%. TG>4.5mmol/L. Suffering from congenital heart disease, rheumatic heart disease, kidney disease, serious active liver disease, peptic ulcer disease or malabsorption syndrome. There is a history of pancreatitis or endocrine diseases other than diabetes, diabetes treated with insulin. Not suffered myocardial infarction in Past 3 months or unstable angina were confirmed. Had been diagnosed as post-surgical adhesions . There is a history of appetite or abuse of laxatives Diastolic blood pressure,uncontrolled or controlled, three times greater than 105mmHg . Pregnancy, prepare to pregnant or lactating women prepare. Allergies to Chinese medicine , allergic. Recurrent gallstone or a history of kidney stones. Mentally ill. Cancer patients. A history of gastrointestinal surgery to lose weight. Receiving other clinical studies nearly 3 months. Alcohol and / or psychoactive substances, drug abusers and addicts. Taking other weight-reducing aid Close within one month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Dose treatment group, 10% | Drug: placebo<br>* Therapeutic dose of 10%<br>|
| Active Comparator: Xinju Xiaogao Prescription<br>treatment group | Drug: Xinju Xiaogao Prescription<br>* treatment group<br>* Other names: Xinju Xiaogao decoction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waistline |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adiposity