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Clinical trial to evaluate the efficacy and safety of Omija on obesity

A 12-week, randomized, double-blind, parallel placebo-controlled human trial to evaluate the efficacy and safety of Omija single extract on body fat

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003951
Enrollment
60
Registered
2019-05-20
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : At the Visit 1(baseline), a subject is randomly assigent to one of the following two groups(Experimental group or control group). And subjects will take Omija sigle extract or pla

Sponsors

Wonkwang University, Gwangju Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Body fat mass

Secondary

MeasureTime frame
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)

Countries

Korea, Republic of

Contacts

Public ContactYoung Kwon

Wonkwang University, Gwangju Medical Center

exeterin@naver.com+82-62-670-6452

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026