Xinju Xiaogao Prescription Study on Overweight

NCT ID: NCT01142076

Last Updated: 2013-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-03-31

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.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

placebo

Dose treatment group, 10%

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Therapeutic dose of 10%

Xinju Xiaogao Prescription

treatment group

Group Type: ACTIVE_COMPARATOR

Xinju Xiaogao Prescription

Intervention Type: DRUG

treatment group

Interventions

Xinju Xiaogao Prescription

treatment group

Intervention Type: DRUG

placebo

Therapeutic dose of 10%

Intervention Type: DRUG

Other Intervention Names

Xinju Xiaogao decoction

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

OTHER

Sponsor Role: collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Fengmei Lian

chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fenglian Li, PHD

Role: STUDY_DIRECTOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other Identifiers

19850701

Identifier Type: -

Identifier Source: org_study_id