Xinju Xiaogao Prescription Study on Overweight

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01142076
• Date of registration: 24/05/2010
• Primary sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Public title: Xinju Xiaogao Prescription Study on Overweight XJXG
• Scientific title: Xinju Xiaogao Prescription and 10% of it in the Treatment of Adiposity (Stagnation of QI Causing Phlegm Retention)Clinical Study
• Date of first enrolment: June 2010
• Target sample size: 2
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01142076
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Contacts

• Name: meifeng Lian, PHD

• Name: Fenglian Li, PHD
• Affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Overweight

Intervention(s)

Drug: placebo

Drug: Xinju Xiaogao Prescription

Primary Outcome(s)

waistline [Time Frame: up to 24 weeks]

Secondary Outcome(s)

Body Mass Index (BMI) [Time Frame: up to 24 weeks]

Secondary ID(s)

19850701

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

China-Japan Friendship Hospital

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences