Xinju Xiaogao Prescription Study on Overweight

Overweight Clinical Trial

— XJXG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142076
• Other study ID #: 19850701
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: December 10, 2013
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: December 2013
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight

Intervention

Drug:
• Xinju Xiaogao Prescription
treatment group
• placebo
Therapeutic dose of 10%

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	China-Japan Friendship Hospital, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	waistline		up to 24 weeks	Yes
Secondary	Body Mass Index (BMI)		up to 24 weeks	Yes