Xinju Xiaogao Prescription Study on Overweight (XJXG)

This study has been completed.
Sponsor:
Collaborators:
China-Japan Friendship Hospital
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Information provided by (Responsible Party):
Fengmei Lian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01142076
First received: May 24, 2010
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Overweight
Drug: Xinju Xiaogao Prescription
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Xinju Xiaogao Prescription and 10% of it in the Treatment of Adiposity (Stagnation of QI Causing Phlegm Retention)Clinical Study

Resource links provided by NLM:


Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • waistline [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Xinju Xiaogao decoction

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142076

Sponsors and Collaborators
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
Investigators
Study Director: Fenglian Li, PHD Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  More Information

No publications provided

Responsible Party: Fengmei Lian, chief, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01142076     History of Changes
Other Study ID Numbers: 19850701
Study First Received: May 24, 2010
Last Updated: December 10, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
adiposity

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014