CTRI/2019/02/017506已完成未知
A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of a Novel Herbal Composition Improving Aging Male Symptoms - AMS Study
aila Neutraceuticals Pvt Ltd0 个研究点目标入组 0 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
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
- •1.Male subjects aged between 36 and 55 years with a Body Mass Index (BMI) between 22 and 29 kg/m2.
- •2.Subjects with aging malesâ?? symptoms (AMS) total score between 27 and 43.
- •3.Willingness to walk for 30 min per day (5 days a week) during the course of the study.
- •4.Subjects should have willing partners; considered generally healthy as per health history and routine clinical investigations.
- •5.Ability to understand the risks and benefits of the protocol.
- •6.Subjects who provide written informed consent and agree to be available for regular follow up throughout the study duration.
- •7.Subjects agree to maintain the activity diary.
- •8.Subjects who agree not to start any therapies for sexual health or consuming energy boosting supplements or protein supplements or health drinks during the course of the study.
- •9.Subjects willing to refrain from drinking coffee or caffeinated drinks or beverages during the study.
排除标准
- •1.Subjects with history of taking medications for erectile dysfunction, oligospermia or any other sexual problems, urinary & prostate diseases and muscular dystrophy.
- •2.Subjects with clinical history of endocrine disorders e.g. hypopituitarism, pituitary tumors, hypo- and hyper-thyroidism, hypogonadism, inherited (genetic and chromosomal) disorders, etc.
- •3.Subjects diagnosed with sleep apnea or related disorders.
- •4.Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
- •5.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •6.Subjects consuming alcohol ( >6 standard drinks per week) or smoking.
- •7.Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
- •8.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 is prohibited.
- •9.Subjects having history of Benign Prostate Hyperplasia (BPH), hypertension (BP >130/85 mmHg), diabetes (fasting plasma glucose >125mg/dL) stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months.
- •10.Subjects under medications including anti-hypetensives, inhaled beta agonists, anti-hyperlipidemics, psychotropic etc.
- •11.Subjects who underwent major surgical procedures in last 6 months.
- •12.Subjects with HIV positive or any other STDs.
- •13.Subject has illness as per the opinion of investigator.
- •14.Subjects 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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