Xinju Xiaogao Prescription Study on Overweight

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Drug: placebo; Drug: Xinju Xiaogao Prescription

• Registration Number: NCT01142076
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2010-05-24
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Dose treatment group, 10%
Xinju Xiaogao Prescription	Xinju Xiaogao Prescription	treatment group

Primary Outcome Measures

Name	Time	Method
waistline	up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	up to 24 weeks