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Clinical trial to evaluated the efficacy and safety of Perilla frutescens

A randomized, double-blind, parallel, placebo-controlled clinical trial to evaluated the efficacy and safety of Perilla frutescens extract on decrement of body fat in overweight subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003754
Enrollment
80
Registered
2019-04-12
Start date
2017-07-10
Completion date
Unknown
Last updated
2019-04-23

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 : During the first visit, the study subjects are randomly assigned to either of the following two groups and are given a 12-week period of human-application test products after brea

Sponsors

Wonkwang University, Gwangju Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

MeasureTime frame
Body fat mass measured by Dual energy X-ray absorptiometry,DEXA

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactYoung Kwon

Wonkwang University, Gwangju Medical Center

exeterin@naver.com+82-62-670-6451

Outcome results

None listed

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