CTRI/2019/02/017506已完成不适用
A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of a Novel Herbal Composition Improving Aging Male Symptoms
Laila Neutraceuticals Pvt Ltd3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年11月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Change in Aging males‟ symptoms (AMS) scores from baseline to the end of the study period
研究概览
简要总结
This proposed study is a randomized, double-blind, placebo-controlled trial, investigating the efficacy and safety of two different doses of LN18178 (200mg, and 400 mg) versus placebo in improving the symptoms of aging in men aged between 36-55 years. The improvement in symptoms will be analysed by the standard scoring system for aging males symptoms and associated serum bio-markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 36.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male subjects aged between 36 and 55 years with a Body Mass Index (BMI) between 22 and 29 kg/m
- •2.Subjects with aging males‟ symptoms (AMS) total score between 27 and
- •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.
结局指标
主要结局
Change in Aging males‟ symptoms (AMS) scores from baseline to the end of the study period
时间窗: Baseline, 7th, 14th, 28th, and 56 Days
次要结局
- Change from baseline to the end of the study period in:(1.Total testosterone)
研究者
研究点 (3)
Loading locations...
相似试验
Unknown
4 期
Smoking Cessation Program in the Preadmission ClinicSmokingNCT00937508University Health Network, Toronto290
已完成
3 期
A Study With SAGE-547 for Super-Refractory Status EpilepticusSuper-Refractory Status EpilepticusNCT02477618Supernus Pharmaceuticals, Inc.132
招募中
不适用
A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & GrowthSkeletal Muscle Strength & GrowthNCT06127849Vedic Lifesciences Pvt. Ltd.138
已完成
2 期
Phase 2 Study of KHK4577Atopic DermatitisNCT02004119Kyowa Kirin Co., Ltd.93
已完成
2 期
Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation in FilipinosPediculosis CapitisNCT03286101United Laboratories120