The clinical study for the evaluation of the efficacy and safety of YY-312(Herbal extract composition; Evodiae fructus, Imperatae rhizome and Citrus unshiu markovich) on reducing body weight and body fat mass of obese Korean. : a 12 weeks, randomized, double-blind, placebo-controlled clinical trial
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0001225
- Lead Sponsor
- Yuyu Phama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 60
1) Male and female subjects between 19-60years of age inclusive.
2) BMI of 25.0 - 30.0kg/m2
3) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
1) Subjects with systolicBP = 160 mmHg or diastolicBP = 100 mmHg and also taking a beta blocker or a hydragogue
2) Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL
3) Subjects with endocrinopathy or abnormal screening TSH(Thyroid-Stimulating Hormone) value(=0.1uU/ml or =10 uU/ml)
4) Subjects with hyperlipidemia) (fasting triglycerides > 600mg/dl)
5) Serum AST(aminotransferse)/ALT(alanine amintransferse) = 3 times the upper limit of normal
6) Serum creatinine = 1.5 times the upper limit of normal
7) Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon
8) Subjects with taking drugs that can affect the body weight within the 3 months
9) Subjects with clinically significant cardiovascular disease within the 6 months prior to screening
10) Subjects who change weight more than 4kg within 4 months
11) Subjects with pancreatopathy
12) Subjects with chronic malabsorption syndrome or bile secretion disorder
13) Subjects with undergoing gastrointestinal operation for reducing boy weight
14) Subjects with postoperative intestinal adhesion
15) Subjects with a history of cancer and intervention within the 5 years prior to screening
16) Subjects with a history of CNS(central nervous system) disorder(depressive disorder, schizophrenia, alcoholism, drug addiction)
17) Subjects with heart disease, kidney disease, liver disease, lung disease and cerebrovascular disease
18) Subjects with gallbladder diseases, gastrointestinal diseases, gout and porphyria
19) Subjects with asthma and allergic disease
20) Subjects with bulimia and abuse of relievers
21) Women of childbearing age who are disagreed with effective contraceptions in the clinical trial period
22) Woman who are pregnant or lactating
23) Participation in any clinical trial within the 1 month prior to screening.
24) Subjects who could affect preclude evaluation of response in the opinion investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fat percentage(by DEXA) ;Fat mass(by DEXA)
- Secondary Outcome Measures
Name Time Method Body weight;Waist circumference