Xinju Xiaogao Prescription Study on Overweight (XJXG)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Overweight

Treatments: Drug: Xinju Xiaogao Prescription; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01142076

19850701

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Dose treatment group, 10%

Treatment:

Drug: placebo

Xinju Xiaogao Prescription

Active Comparator group

Description:

treatment group

Treatment:

Drug: Xinju Xiaogao Prescription