A double-blind, placebo-controlled study on the impact of Shilajit gummies on sexual wellness, energy, and metabolic health in revitalizing middle-aged male health.
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1.Changes in free testosterone and total testosterone levels
研究概览
简要总结
Sexual dysfunction and associated metabolic syndrome are common health problems among middle-aged men and can significantly impact their quality of life. Sexual dysfunction can result from low testosterone and low or elevated thyroid hormones. Their management necessitates a tailored approach considering the underlying etiology, severity, and associated medical conditions. Decreased libido is a common concern, often influenced by factors like age, mental health, and hormonal changes. While it’s a natural part of aging, conditions like late-onset hypogonadism (LOH) can contribute to more significant declines. Nutraceutical supplements may offer potential support for maintaining healthy libido and overall well-being.
While conventional therapies exist, they often exhibit adverse health effects. Conversely, phytotherapeutic interventions offer a more efficacious approach to managing diseases by modulating biological processes such as inflammation, oxidative stress, and intracellular signaling. Numerous medicinal plants have been documented to exert beneficial effects on erectile function. The hypothalamus’s role in converting testosterone to estradiol may be crucial for testosterone’s effects on libido. Some herbs have also been shown to increase testosterone levels in men.
A recent study highlighted a strong connection between libido and cardiovascular diseases, suggesting that preserving libido may positively impact cardiovascular health and overall well-being in men. The rationale for this study centers on the vital role of supplement in maintaining sexual wellness, metabolic health, energy level and overall well-being in middle aged men. Sexual dysfunction, impotence, and related issues have been a longstanding challenge for the scientific community and medical practitioners. These conditions can have significant psychosocial implications, affecting men in various ways. There has been a continuous search for novel herbal and chemical agents to address the persistent battle to combat sexual dysfunction and maintain metabolic and sexual health with increasing age.
This randomized, double-blind, placebo-controlled clinical trial will evaluate the impact of Shilajit gummies on sexual wellness, energy, and metabolic health in revitalizing middle-aged male health. By integrating traditional therapeutic principles with modern scientific research, this study aims to offer a comprehensive and holistic approach to restoring energy, sexual wellness, metabolic health, and testosterone levels and enhancing overall well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- Male
入选标准
- •Male participants aged 45-55 years (both inclusive) with BMI not more than 30 kg per meter square
- •Participants with positive Saint Louis University Androgen Deficiency in Aging Males (ADAM) questionnaire indicative of testosterone deficiency at screening visit
- •Participants with at least three of the following metabolic syndrome criteria (NCEP ATP III) -serum triglycerides: greater than or equal to 150 mg per dL, HDL cholesterol- less than or equal to 40 mg per dL in men, blood pressure- greater than or equal to 130 mm Hg systolic or greater than or equal to 85 mm Hg diastolic, fasting plasma glucose greater than or equal to 100 mg per dL, Abdominal obesity, waist circumference: men greater than 90 cm
- •Participants should be in an active stable sexual relationship for the entire duration of the study
- •Participants willing to participate in clinical trials and who have read understood and signed the informed consent form.
排除标准
- •Previous events or other severe conditions that may affect sexual health or metabolic health
- •Participants with genital anatomical deformities, including but not limited to penile deformities
- •Participants for whom sexual activity is inadvisable because of their underlying disease status
- •Female partners experiencing sexual dysfunction, such as painful intercourse, low libido, or other forms of sexual dysfunction, as well as pregnant individuals
- •Participants with any significant comorbid condition or currently undergoing pharmacological treatment, which in the investigators judgment may interfere with the clinical trial outcomes
- •Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs
- •Participants with a history or presence of significant alcoholism or drug abuse within the past 1 year
- •Participants with a history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco or nicotine products more than 10 times per day
- •Any concomitant treatment that is not permissible including but not limited to nitrates, anti androgens, chemotherapy agents, radiotherapy, etc.
- •Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol
- •Known hypersensitivity to any of the ingredients of the investigational product
- •Participants concurrent use of sildenafil or other such drugs in the PDE5 inhibitor family, energy supplements, herbal or pharmaceutical aphrodisiacs, body composition enhancing agents, or other concurrent medication such as beta blockers, contraceptives, and psychotropic medications, nutraceuticals, or ayurvedic supplement for sexual health & well-being
- •Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
结局指标
主要结局
1.Changes in free testosterone and total testosterone levels
时间窗: screening, day 30, day 60 and day 90
2.Changes in libido system score (LSS) score.
时间窗: screening, day 30, day 60 and day 90
3.Changes in sexual stamina using intravaginal ejaculatory latency time (IVELT) score.
时间窗: screening, day 30, day 60 and day 90
4.Metabolic Syndrome Severity Z Score (MetZ score).
时间窗: screening, day 30, day 60 and day 90
MetZ score is derived from five key components of Metabolic Syndrome (waist circumference, triglycerides, HDL cholesterol, systolic blood pressure, and fasting plasma glucose)
时间窗: screening, day 30, day 60 and day 90
5.Changes in cardiorespiratory endurance by VO2 max by step test.
时间窗: screening, day 30, day 60 and day 90
次要结局
- 1. Changes in anthropometric parameters including body weight (kg), waist circumference and BMI.(2. Changes in Fatigue Severity Scale (FSS) score.)
研究者
Dr Ramshyam Agarwal
Health Nexus Research Centre
