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 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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
•Subjects who is consuming/ has received any performance enhancing medication.
•Subjects undergoing any additional weight loss or diet plan during the trial period
•Chronic alcoholics
•Drug abusers
•Pregnant, willing to get pregnant or not ready to use contraceptive measures during the study period
•Participation in any other clinical trial during last 30 days
•Simultaneous participation in another clinical trial.

发起方

Indus Biotech Private Limited Pune