Clinical Evaluation of the Effect of Meet Shilajeet-K on Spermatogenic Activity in Men with Oligospermia: An Open Label Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from the baseline (Semen analysis results from screening visit) to the end of the supplement period (Day 90) in
研究概览
简要总结
It aims to evaluate the effect of Meet Shilajeet-K supplementation (500 mg daily for 90 days) on spermatogenic activity, semen quality, and hormonal profiles in adult males diagnosed with oligospermia. The primary objective is to assess changes in sperm concentration, total sperm count, and total motility over a 3-month period. Secondary objectives include evaluating additional semen parameters such as volume, liquefaction time, viscosity, pH, and fructose levels, as well as assessing changes in sperm morphology (normal and abnormal forms) and sperm vitality. The study will also monitor the safety and tolerability of Meet Shilajeet-K through liver and renal function tests. This trial seeks to provide scientific evidence for the potential role of Meet Shilajeet-K as a non-invasive treatment option for men with oligospermia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Participants eligible for inclusion in the study must meet the following criteria: 1)Adult males aged 25 to 45 years.
- •Diagnosed with oligospermia (sperm concentration less than 20 million ml) in the semen sample collected during the screening period with or without progressive sperm motility of less than 30 percent and less than 4 percent of sperm with normal morphology.
- •Willing and able to provide semen samples during the screening and at end of study, following 2 to 7 days of sexual abstinence for each sample.
- •Willing to use acceptable contraception during the study period of 90 days.
- •No use of any spermatogenic enhancing drugs like hormonal medications, investigational reproductive drugs, prescription fertility treatments in the past 3 months.
- •Consumed any nutraceuticals, over the counter supplements or herbal remedies to manage oligospermic condition within 30 days prior to screening and baseline visit.
- •No history of chronic systemic diseases (e.g. diabetes, hypertension, hyperlipidemia, thyroid disorders).
- •Subjects should be available for duration of study period (90 days).
- •Willing and able to comply with study procedures including scheduled visits, dosing regimen, semen collections, and safety assessments.
- •Provided written informed consent voluntarily before any study related procedure.
- •Subjects willing to refrain from smoking and drinking for the duration of the study.
排除标准
- •The study will exclude individuals meeting any of the following criteria: 1) History of infertility due to non-oligospermic causes (e.g., obstructive azoospermia, genetic disorders).
- •Individuals with azoospermia or necrospermia/ necrozoospermia.
- •Chronic use of medications affecting spermatogenesis (e.g., anabolic steroids, chemotherapy).
- •Clinically significant medical conditions, including but not limited to cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (such as uncontrolled diabetes or thyroid disease), or haematological abnormalities.
- •Individuals with a history of mumps, measles, smallpox, chicken pox, tuberculosis or injury to genitalia in the preceding 10 years.
- •Known hypersensitivity or allergy to Shilajit or its components.
- •Participation in any other clinical trial within the last 3 months.
- •Current heavy smokers (Greater 20 cigarettes/day) or participants with ongoing hazardous alcohol consumption (Greater 14 standard drinks/week).
结局指标
主要结局
Change from the baseline (Semen analysis results from screening visit) to the end of the supplement period (Day 90) in
时间窗: Day 0 and Day 90
1) Change in sperm concentration from the baseline to the end of the supplement period.
时间窗: Day 0 and Day 90
2) Change in total sperm count from the baseline to the end of the supplement period.
时间窗: Day 0 and Day 90
3) Change in total sperm motility from the baseline to the end of the supplement period.
时间窗: Day 0 and Day 90
次要结局
- Any change from the baseline to the end of the supplement period Day 90 in:(1) Semen parameters:)
研究者
Shruthi Rao
TrialGuna Private Limited