Xinju Xiaogao Prescription Study on Overweight (XJXG)

December 10, 2013 updated by: Fengmei Lian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Dose treatment group, 10%
Drug: placebo
Therapeutic dose of 10%
Active Comparator: Xinju Xiaogao Prescription
treatment group
Drug: Xinju Xiaogao Prescription
treatment group
Other Names:
  • Xinju Xiaogao decoction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
waistline
Time Frame: up to 24 weeks
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body Mass Index (BMI)
Time Frame: up to 24 weeks
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
China-Japan Friendship Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19850701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe