Clinical trial to evaluated the efficacy and safety of Perilla frutescens
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003754
- Lead Sponsor
- Wonkwang University, Gwangju Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
(1) An adult male and female over the age of 19 and under 65 at the time of screening.
(2) Volunteers with a BMI of 25 to 29.9 kg / m2 at screening
(3) After fully hearing and understanding the details of this study, volunteers who have agreed to volunteer their participation
(1) Those who have a BMI of 30 kg / m2 or more at the screening screening.
(2) Those who lost more than 10% of their weight within 3 months before the screening test.
(3) Those who have experience in taking medications or health-function foods that may affect research results such as diet pills and lipid degradation agents within four weeks prior to screening (However, they can participate after a four-week break before the first day of intake).
(4) Those with acute severe cardiovascular disease such as heart failure, myocardial infarction, and stroke.
(5) Those with immune-related disease or severe hepatic / renal failure or who have a history.
(6) Those with a history of clinically significant hypersensitivity reactions to drugs and health functional foods.
(7) Persons with a history of gastrointestinal disorders (eg, Crohn's disease) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of research products.
(8) Persons who have received antipsychotic medication within 2 months before screening.
(9) A person with a history of drug or alcohol abuse.
(10) Those who participated in other studies within 2 months before screening.
(11) Clinical pathologists who show the following results.
- AST, ALT> three times the upper limit of the reference range
- Serum Creatinine > 2.0 mg/dL
- Creatine Kinase(CK) > three times the upper limit of the reference range.
(12) Systolic blood pressure greater than 180 mmHg and relaxation pressure greater than 110 mmHg.
(13) A person diagnosed with diabetes.
(14) Postmenopausal women, postmenopausal hormone-taking women
(15) A pregnant or breast-feeding woman.
(16) Women who are pregnant and do not accept the appropriate contraceptive practice (except for women who have undergone sterilization).
(17) A person who is deemed unsuitable for participation in research due to the results of clinical pathology tests or other reasons.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body fat mass measured by Dual energy X-ray absorptiometry,DEXA
- Secondary Outcome Measures
Name Time Method Percent Body fat and Fat Free Mass measured by Dual energy X-ray absorptiometry,DEXA;Physical measurement indicator : Body weight, Body mass index(BMI);Physical measurement indicator : Waist circumference, Hip circumference, Waist / hip circumference ratio (WHR);Geological Metrics: Total cholesterol;Geological Metrics :Triglyceride;Geological Metrics : Low-Density Lipoprotein Cholesterol(LDL-C);Geological Metrics : High-Density Lipoprotein Cholesterol(HDL-C);Geological Metrics :Non High-Density Lipoprotein Cholesterol(Non HDL-C);Glucose, Insulin;Leptin, Adiponectin;Adverse events;Clinical pathology test;Vital signs