A study to evaluate the effect of GenF20 Plus on IGF-1 levels in normal to overweight adult volunteers with poor quality of sleep, decreased memory, decreased libido and low energy levels - None

eading Edge Marketing0 个研究点目标入组 80 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1) Adults with any 2 of the following conditions: poor quality of sleep, decreased memory, decreased libido and low energy levels ? with the affected parameters (of sleep, memory, libido and energy levels) perceived to be of grade 1 or 2 on a Likert scale. The above conditions should have been present since at least 1 month.
•2) Body Mass Index between 18.5 to 29.9 kg/m2
•3) Willing to give written informed consent and abide with trial procedures and come for the follow up visits
•4) Women willing to practice suitable contraception (except oral contraceptives) during the study
•5) Willing to continue current lifestyle practices with no modifications (in diet and exercise ) during the study period

•1) Adults with uncontrolled conditions of diabetes, hypertension, hypothyroidism, hyperthyroidism
•2) Hepatic or renal impairment
•3) Women on oral contraceptives, estrogen supplements and corticosteroids
•4) Significant cardiovascular co-morbidities, e.g. symptomatic heart failure, a history of ischemic heart disease (as evident from ECG), history of stroke and/or TIA.
•5) Women with estrogen sensitive disorders like breast cancer, uterine cancer, ovarian cancer, endometriosis and uterine fibroids
•6) Debilitating neurological or psychiatric disorders including seizure disorders and depression.
•7) Known hypersensitivity or allergy to one or more of the ingredients of the IP.
•8) Known history of allergy to milk and milk products.
•9) Recent ( 1 month) participation in a clinical trial
•10) Any condition likely to hinder the compliance with the protocol.
•11) Heavy smoking (more than 10 cigarettes per day) or chronic alcoholics.
•12) Pregnant and lactating women
•13) Subjects who have begun an exercise and/or diet regimen within 30 days of the screening visit
•14) Known cases of acromegaly

发起方

eading Edge Marketing