Clinical trial to evaluate the efficacy and safety of Omija on obesity
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003951
- Lead Sponsor
- Wonkwang University, Gwangju Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
1. Adults over 19 years
2. BMI of 23 kg/m2 or higher at the time of screening, with a body fat rate of 25 % for males and 30% for females
3. Those who have heard the full explanation of this human application test, fully understand it, and have voluntarily decided to participate and have agreed in writing to comply with the precautions.
1. Those who have lost more than 10% of their weight within 3 months prior to screening
2. high obesity(BMI over 35 kg/m2)
3. Products that affect weight within one month of the screening test are being taken (concomitant medication references) with improved body fat health food or medicines, contraceptives, steroids, and female hormones).
4. Persons with clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, interdialogal system, kidney and urinary machinery, nervous system, musculoskeletal system, inflammatory and blood tumor disease, gastrointestinal diseases, etc.
5. Diabetic patients with oral hypoglycemic agents or insulin injections (as at the time of the subject's screening)
6. A person who has a history of clinically significant hypersensitivity in the ingredient of Omija.
7. Those who have had experience in antipsychotic medication within three months prior to screening.
8. Those who participated in other human application tests within 3 months prior to the screening test.
9. Someone who has or is suspected of drug or alchol abuse.
10. A menopause woman
11. A pregnant or breast-feeding woman.
12. where appropriate contraception has not been accepted among fertile women.
13. Diagnostic test A person who is determined by the Principal inspector to be ineligible for research due to medical examination results or other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body fat mass
- Secondary Outcome Measures
Name Time Method Weight;Percent body fat;Fat free mass;Waist circumference;hip circumference;Concentraion of adiponectin;Concentraion of leptin;Adverse events;laboratory test value;Vital sign;EKG(Electrocardiogram)