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Xinju Xiaogao Prescription Study on Overweight (XJXG)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Xinju Xiaogao Prescription
placebo
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring adiposity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    placebo

    Xinju Xiaogao Prescription

    Arm Description

    Dose treatment group, 10%

    treatment group

    Outcomes

    Primary Outcome Measures

    waistline

    Secondary Outcome Measures

    Body Mass Index (BMI)

    Full Information

    First Posted
    May 24, 2010
    Last Updated
    December 10, 2013
    Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    Collaborators
    China-Japan Friendship Hospital, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01142076
    Brief Title
    Xinju Xiaogao Prescription Study on Overweight
    Acronym
    XJXG
    Official Title
    Xinju Xiaogao Prescription and 10% of it in the Treatment of Adiposity (Stagnation of QI Causing Phlegm Retention)Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    March 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    Collaborators
    China-Japan Friendship Hospital, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight
    Keywords
    adiposity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Dose treatment group, 10%
    Arm Title
    Xinju Xiaogao Prescription
    Arm Type
    Active Comparator
    Arm Description
    treatment group
    Intervention Type
    Drug
    Intervention Name(s)
    Xinju Xiaogao Prescription
    Other Intervention Name(s)
    Xinju Xiaogao decoction
    Intervention Description
    treatment group
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    Therapeutic dose of 10%
    Primary Outcome Measure Information:
    Title
    waistline
    Time Frame
    up to 24 weeks
    Secondary Outcome Measure Information:
    Title
    Body Mass Index (BMI)
    Time Frame
    up to 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fenglian Li, PHD
    Organizational Affiliation
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Xinju Xiaogao Prescription Study on Overweight

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