Xinju Xiaogao Prescription Study on Overweight (XJXG)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
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
Information provided by:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01142076
First received: May 24, 2010
Last updated: June 10, 2010
Last verified: May 2010
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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 ]
| Estimated Enrollment: | 2 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | March 2011 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142076
Contacts
| Contact: meifeng Lian, PHD | 01088001402 | lfm565@sohu.com |
| Contact: linhua zhao, PHD | 88001402 |
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: | China: Traditional Chinese Medicine Administration |
| ClinicalTrials.gov Identifier: | NCT01142076 History of Changes |
| Other Study ID Numbers: | 19850701 |
| Study First Received: | May 24, 2010 |
| Last Updated: | June 10, 2010 |
| 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 May 23, 2013