Xinju Xiaogao Prescription Study on Overweight

NCT01142076 | Completed DMC

• 1 other identifier: 19850701
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Overweight

Keywords

adiposity

Outcome Measures

Primary Outcomes (1)

• waistline

  up to 24 weeks

Secondary Outcomes (1)

• Body Mass Index (BMI)

  up to 24 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

Dose treatment group, 10%

Drug: placebo

Xinju Xiaogao Prescription

ACTIVE COMPARATOR

treatment group

Drug: Xinju Xiaogao Prescription

Interventions

Xinju Xiaogao Prescription DRUG

treatment group

Also known as: Xinju Xiaogao decoction

Xinju Xiaogao Prescription

placebo DRUG

Therapeutic dose of 10%

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• China-Japan Friendship Hospital: collaborator
• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: collaborator

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fenglian Li, PHD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: June 11, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 11, 2013

Record last verified: 2013-12