Effect of herbal extract on reducing body fat in healthy adults

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 120

Inclusion Criteria

Male and female individuals aged from 19 to 60 (both inclusive) years 2.
BMI between â‰¥ 25, <30 kg/m2 3.
Participants who voluntarily agrees to participate and signs on informed consent form.

Exclusion Criteria

Participants with a history of hypersensitivity to drugs, food ingredients, herbal extracts, or dietary supplements 2.
Participants who have had participated in a commercial weight loss program or clinical trial for obesity within the last three months 3.
Participants taking drugs or diet foods that affect their weight within 3 months prior to screening (absorption inhibitors, appetite suppressants, health functional foods/supplements related to obesity improvement, psychiatric drugs such as depression, diuretics, contraceptives, steroids, female hormones) 4.
Participants with intentional weight loss of at least 5% within 3 months prior to screening 5.
Participants who have undergone surgery, such as gastroplasty and intestinal resection, to lose weight within 6 months prior to screening 6.
Endocrine diseases such as hypothyroidism and Cushingâ€™s syndrome 7.
Participants with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last 6 months (However, those who are clinically stable may participate in the trial at the investigatorâ€™ discretion) 8.
Serious dysfunction of the liver (alanine and aspartate aminotransferase levels of 3.0 times the upper limit or normal) or kidney (creatinine > 2.0 mg/dL) 9.
Uncontrolled hypertension (blood pressure â‰¥ 160/100 mmHg) 10.
Fasting blood glucose â‰¥ 126 mg/dL or random blood glucose â‰¥ 200 mg/dL, or diabetic patients taking oral hypoglycemic agents or insulin 11.
Malignant tumor diagnosed within 3 years prior to screening 12.
Participants who complain of severe gastrointestinal symptoms such as heartburn and indigestion 13.
Participants with a psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol or the other drug abuse 14.
Pregnant or lactating participants, or women of childbearing age who do not agree to use contraception during the trial 16.
Participants with a history of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.
Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigatorâ€™s opinion.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Change in body fat rate %	Baseline and week 12

Secondary Outcome Measures

Name	Time	Method
6) Serum concentration measurements	âœ“ leptin
Other Evaluations	a) Dietary Record
1) Change in physical measurement	âœ“ Weight
2) Change in Body Mass Index (BMI)	Baseline, week 4, week 8, week 12
3) Blood lipid concentration (Total-C, HDL-C, LDL-C, Triglyceride)	Baseline, week 4, week 8, week 12
4) DEXA (Dual-Energy X-ray Absorptiometry)	âœ“ Body fat amount(g)
5) Abdominal fat CT (computed tomography) (between lumbar spine 4-5)	âœ“ visceral fat area,

Trial Locations

Locations (2): Sanjeevini Hospital
🇮🇳
Bangalore, KARNATAKA, India
Vagus Super Speciality Hospital
🇮🇳
Bangalore, KARNATAKA, India
Sanjeevini Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Srihari US
Principal investigator
9480025659
us.srihari@gmail.com