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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Change from baseline to the end of the study
研究概览
简要总结
The purpose of this study is to assess efficacy, safety and tolerability of an herbal composition LN18178 in improving testosterone level in healthy young males. A total of 120 healthy males of age between 21 and 35 years will be screened for eligibility criteria as per the study protocol. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per computer generated randomization list. Subjects will be assigned to either one of the three study groups (LN18178 200mg, LN18178 400mg or Placebo) and instructed to take the Investigational products for a period of 56 days. This study will measure serum hormones, grip strength, and mid upper arm circumferences of the participants, as the efficacy parameters. Besides, the study will also record the vital signs, and adverse events to estimate the herbal composition’s safety and tolerability. The safety assessment of the test product will also include the routine laboratory investigations on blood, urine and clinical chemistry parameters at screening and at the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects aged between 21 and 35 years with a Body Mass Index (BMI) between 20 and 29 kg/m
- •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.
结局指标
主要结局
Change from baseline to the end of the study
时间窗: Day 1,7, 14,28 and 56
period in:
时间窗: Day 1,7, 14,28 and 56
Serum testosterone
时间窗: Day 1,7, 14,28 and 56
次要结局
- Change from baseline to the end of the study(period in:)