CTRI/2018/11/016337已完成未知
A randomized, double blind, placebo controlled clinical study to evaluate the efficacy and safety of anovel herbal composition improving testosterone level in healthy young males
aila Nutraceuticals0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male subjects aged between 21 and 35 years with a Body Mass Index (BMI) between 20 and 29 kg/m2.
- •Willingness to do 40 min aerobic exercise per day (4 days a week)during the course of the study.
- •Subject considered generally healthy as per health history and routine clinical investigations.
- •Ability to understand the risks and benefits of the protocol.
- •Subject should provide written informed consent and agree to be available for regular follow up throughout the study duration.
- •Subjects agree to maintain the activity diary.
- •Subject agrees not to start any new therapies for sexual health or energy boosting supplements or protein supplements or health drinks during the course of the study.
- •Subjects willing to refrain from drinking coffee or caffeinated drinks or beverages during the study.
排除标准
- •Subjects who are resistance trained or undergoing resistance training.
- •Subjects with history of taking medications for erectile dysfunction, oligospermia or any other sexual problems, urinary & prostate diseases and muscular dystrophy.
- •Subjects with clinical history of endocrine disorders e.g.hypopituitarism, pituitary tumors, hypo- and hyperthyroidism,hypogonadism, inherited(genetic and chromosomal) disorders, etc.
- •Subjects diagnosed with sleep apnea or related disorders.
- •Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
- •History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Subjects consuming alcohol ( >3 standard drinks per week) or smokers.
- •Subjects who consume recreational drugs (such as cocaine,methamphetamine, marijuana, etc.) or chewable tobacco products.
- •Subjects having history of Benign Prostate Hyperplasia (BPH),hypertension (BP >130/85 mmHg), diabetes (fasting plasma glucose >125 mg/dL), stroke, myocardial infarction, coronary artery disease,cardiac failure, angina, life-threatening arrhythmia within the past 6 months.
- •Subjects under medications including anti-hypertensives, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc.
- •Use of any centrally acting anorectic agents, drugs that inhibit the absorption of nutrients and endocannabinoid neuromodulators during the two weeks prior to enrolment into the study.
- •Subjects who underwent major surgical procedures in last 6 months.
- •Subject with HIV positive or any other STDs.
- •Subject has illness as per the opinion of investigator.
- •Subject has participated in a clinical study within the last 90 days prior to recruitment or concurrently participating in another study.
研究者
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