KCT0002208
Recruiting
未知
A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors - Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial
Gil Korean Medicine Hospital, Gachon University0 sites120 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gil Korean Medicine Hospital, Gachon University
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female aged 18 to 65 years
- •\- Subject must included at least one or more of the following symptoms below
- •? Body Mass Index of 30 kg/? or more;
- •? Body Mass Index between 25 and 29\.9kg/? with hypertension, taking medication or systolic blood pressure \= 140mmHg or diastolic blood pressure \= 90mmHg at the screening visit
- •? Body Mass Index between 25 and 29\.9kg/? with non\-insulin\-dependent diabetes mellitus, taking medication or fasting blood glucose \> 126mg/dL at the screening visit
- •? Body Mass Index between 25 and 29\.9kg/? with hyperlipidemia, taking medication or total cholesterol \= 200mg/dL or Triglyceride \= 150mg/dL at screening visit
- •\- Agreed to low\-calorie diet during the trial
- •\- Written informed consent of the trial
Exclusion Criteria
- •\- Endocrine diseases associated with weight gain, such as hypothyroidism, Cushing's syndrome, etc.
- •\- Heart disease (heart failure, angina pectoris, myocardial infarction)
- •\- Cholelithiasis
- •\- Severe renal disability (serum creatinine concentration \> 2\.0 mg/dL)
- •\- Severe liver disability (2\.5 fold of normal high range value on Alanine Aminotransferase \[ALT], Aspartate Aminotransferase \[AST], alkaline phosphatase)
- •\- History of narrow angle glaucoma
- •\- History of stroke or temporary ischemic cardioplegia
- •\- History of eating disorder such as anorexia nervosa or bulimia nervosa, etc.
- •\- Use of medication that can affect on weight within last 3 months (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medications can affect on absorption, metabolism, excretion)
- •\- Use of central nerve system(CNS) stimulant medication for weight loss
Outcomes
Primary Outcomes
Not specified
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