A randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of TruBlk TM Shilajit Resin in improving sexual health in males.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1) Changes in levels of total testosterone, free testosterone, cortisol, and nitric oxide
研究概览
简要总结
Sexual health significantly impacts the overall well-being and quality of life of middle-aged men. Factors such as declining testosterone levels, oxidative stress, and stress-related issues can lead to sexual dysfunction. Hypogonadism, affecting a substantial portion of the male population, particularly older men, impacts not only sexual function but also physical, mental, and emotional health. Decreased libido is a common concern influenced by factors such as age, mental well-being, and hormonal fluctuations.
Cross-sectional studies have revealed an annual decline in morning total testosterone levels of 0.2-2% in men aged 40 and older. Furthermore, in elderly males, the coordinated release of LH and testosterone becomes desynchronized despite the maintenance of normal serum levels of these hormones. Results of previously conducted studies suggest that in middle-aged men, less pulsatile testosterone and more LH are secreted at night than in young men, with disruption of the association between testosterone rhythm and REM sleep. The decline in nocturnal testosterone secretion appears to involve a combination of testicular and pituitary hypogonadism.
Sexual dysfunction can arise from imbalances in testosterone and thyroid hormone levels, necessitating a personalized management approach considering the underlying cause, severity, and associated health conditions. Nutraceutical supplements may offer potential support for maintaining healthy libido and overall well-being.
Adverse health effects are a common concern with conventional therapies. Conversely, Ayurvedic supplementation may offer a complementary approach to conventional treatments for managing diseases by modulating biological processes such as inflammation, oxidative stress, and intracellular signaling. Research indicates that several medicinal plants may positively influence erectile function. Notably, the hypothalamus plays a critical role in converting testosterone to estradiol, a process that may be essential for testosterone’s impact on libido. Moreover, some herbal remedies have demonstrated the ability to elevate testosterone levels in men
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
- 35.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male participants aged 35 to 50 years (both inclusive) with BMI not more than 30 kg/m2 2)Participants who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit 3)Participants with positive Saint Louis University Androgen Deficiency in Aging Males (ADAM) questionnaire indicative of testosterone deficiency at screening visit 4)Participants should be in an active stable sexual relationship (only married participants) for the entire duration of the study 5)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 2)Participants with genital anatomical deformities, including but not limited to penile deformities 3)Participants for whom sexual activity is inadvisable because of their underlying disease status 4)Female partners experiencing sexual dysfunction such as painful intercourse low libido or other forms of sexual dysfunction as well as pregnant individuals 5)Participants with any significant comorbid condition or currently undergoing pharmacological treatment which in the investigators judgment may interfere with the clinical trial outcomes 6)Participants that have undergone radical prostatectomy spinal cord injury or any other surgery of urogenital organs 7)Participants with a history or presence of significant alcoholism or drug abuse within the past 1 year 8)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 9)Any concomitant treatment that is not permissible including but not limited to nitrates anti-androgens chemotherapy agents radiotherapy etc 10)Recent participation in another clinical trial or receiving some other drug during the study besides that in the protocol 11)Known hypersensitivity to any of the ingredients of the investigational product 12)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 and well-being 13) Participants consuming any nutraceutical herbal or ayurvedic supplement for any other condition 14) Any other clinical condition in the investigator judgment finds the study participation unsuitable for the participant.
结局指标
主要结局
1) Changes in levels of total testosterone, free testosterone, cortisol, and nitric oxide
时间窗: 1)screening and day 90 | 2)screening and day 90. | 3)screening day 30, day 60 and day 90 | 4)screening, day 30, day 60 and day 90 | 5)screening, day 30, day 60 and day 90
2) Changes in metabolic parameters like fasting blood sugar, fasting insulin and lipid profile
时间窗: 1)screening and day 90 | 2)screening and day 90. | 3)screening day 30, day 60 and day 90 | 4)screening, day 30, day 60 and day 90 | 5)screening, day 30, day 60 and day 90
3) Changes in libido system score (LSS) score
时间窗: 1)screening and day 90 | 2)screening and day 90. | 3)screening day 30, day 60 and day 90 | 4)screening, day 30, day 60 and day 90 | 5)screening, day 30, day 60 and day 90
4) Changes in the international index of erectile function (IIEF) (erectile and orgasmic functions, sexual desire, satisfaction with intercourse, and overall sexual satisfaction)
时间窗: 1)screening and day 90 | 2)screening and day 90. | 3)screening day 30, day 60 and day 90 | 4)screening, day 30, day 60 and day 90 | 5)screening, day 30, day 60 and day 90
5) Changes in sexual stamina using intravaginal ejaculatory latency time (IVELT) score
时间窗: 1)screening and day 90 | 2)screening and day 90. | 3)screening day 30, day 60 and day 90 | 4)screening, day 30, day 60 and day 90 | 5)screening, day 30, day 60 and day 90
次要结局
- 1)Changes in perceived stress scale (PSS) score(2)Changes in Fatigue Severity Scale (FSS) score)
研究者
Dr Ninad Naik
Lokmanya Medical Research Centre and Hospital