A randomized, double blind, placebo-controlled, parallel arm clinical trial of De-Stress and Perform Capsule in the management of stress-induced premature ejaculation in healthy adult men
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Herbolab India Pvt Ltd
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Primary outcomes are as follows- 1. Changes in perceived stress scale (PSS) score, PEP Score Questionnaire, sexual stamina using intravaginal ejaculatory latency time (IELT),libido system score (LSS), levels of serum testosterone, cortisol and LDH, weight and BMI, COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, cardiorespiratory endurance (maximal oxygen uptake VO2 max), % fat and % skeletal muscle using bioelectrical impedance analysis (BIA), handgrip strength using hand-held dynamometer.
概览
简要总结
The current study focuses on clinical validation of efficacy of nutraceutical product in management of male health. In healthy adult men with induced premature ejaculation, the introduction of these nutraceuticals has been associated with notable improvements in quality of life. These supplements help them for enhanced sexual satisfaction, increased control over ejaculation, and a reduction in performance anxiety. The psychological benefits are significant, as the improvement in sexual function can lead to higher self-confidence and a more positive outlook on life.
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
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male participants aged 21-50 years both inclusive suffering from a.
- •ED 2.Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26 3.Participant having baseline IELT of less than 2 min 4.Participants meeting with diagnostic criteria for PEP score less than or equal to 11
- •Participants who have scored 11 to 25 on the Erectile Function EF domain of the International Index of Erectile Function IIEF at screening visit a subset of 15 patients only that is 5 participants from each group
- •Participants should be in an active stable sexual relationship only married participants for the entire duration of the study 7.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form.
排除标准
- •1.Previous events or other severe conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery 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.Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion.
- •cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynaecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders 6.Participants that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs; 7.Participants with history or presence of significant alcoholism or drug abuse within the past 1 year 8.Participants with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/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 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, nutraceutical, or ayurvedic supplement for stress and/or PE management 13.Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
结局指标
主要结局
Primary outcomes are as follows- 1. Changes in perceived stress scale (PSS) score, PEP Score Questionnaire, sexual stamina using intravaginal ejaculatory latency time (IELT),libido system score (LSS), levels of serum testosterone, cortisol and LDH, weight and BMI, COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, cardiorespiratory endurance (maximal oxygen uptake VO2 max), % fat and % skeletal muscle using bioelectrical impedance analysis (BIA), handgrip strength using hand-held dynamometer.
时间窗: 1.Screening, day 30 and day 60 | 2.Screening and day 60
2.Changes in blood flow assessed by penile doppler in ED participants, STAI (State-Trait Anxiety Inventory), Profile of Mood State (POMS) (a. Total Mood Disturbance b. Depression), cardiorespiratory endurance, Personal Assessment of Intimacy in Relationships (PAIR).
时间窗: 1.Screening, day 30 and day 60 | 2.Screening and day 60
次要结局
- Secondary outcomes are as follows- 1.Assessment of adverse events, treatment compliance and tolerability of investigational products, vital sign parameters 2.Assessment of complete blood count, liver function test and kidney function test(1.Screening, baseline, day 30, day 60)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre and Hospital