CTRI/2013/10/004050
Completed
未知
A prospective, randomized, double blind, placebo controlled, single center study of fenugreek seed extract in individuals with high fat mass
Indus Biotech Private Limited Pune0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- High fat massHealth Condition 2: E663- Overweight
- Sponsor
- Indus Biotech Private Limited Pune
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent from the subject
- •Male or female
- •Age 18\-35 years inclusive
- •Body fat mass measured by skin fold thickness \>25% for males and \>30% for females
Exclusion Criteria
- •Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
- •Subject has an elevated resting heart rate ( \>100 bpm) or blood pressure (SBP more than or equal to 140 or DBP more than or equal to 90 mm Hg).
- •SGOT and SGPT more than or equal to 2 times the upper limit of normal
- •Serum creatinine more than or equal to 2 times the upper limit of normal
- •Hemoglobin \<10 g/dl
- •Subject has a history of medical or surgical events that may affect the study outcome or place the subject at risk, including cardiovascular disease, gastrointestinal problems, metabolic (including but not limiting to diabetes), renal, hepatic, neurological or active musculoskeletal disorders.
- •Subject has a history of orthopedic injury or surgery, which can interfere in activity schedule.
- •Known hypersensitivity to herbal drugs/nutritional supplement/ foods
- •Postmenopausal females
- •Subjects who is consuming/ has received any antiobesity or fat reducing therapy during last 2 months
Outcomes
Primary Outcomes
Not specified
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