Evaluation of efficacy and safety of Vitality Booster Capsules in the management of Stress and Improvement of Vitality in Adults: A prospective, randomised, double-blind, single center, placebo-controlled, interventional study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- DASS-21 score documented in the CRF at baseline, day 15, and day 30 (values and change from baseline - within the group and between the groups comparisons)
研究概览
简要总结
Sexual health is a vital part of life required for good health and reproduction. Poor sexual health, either by psychological or pathological factors, can significantly affect the quality of life of adolescent and adult men. Sexual dysfunction (SD) is a condition of sexual behaviour and sexual sensation that emerges as an abnormality or absence of sexual psychology and physiological reaction. Clinical features of sexual dysfunction in men include erectile dysfunction (ED), premature ejaculation, failure of sexual intercourse and loss of libido/desire.The prevalence of premature ejaculation and erectile dysfunction were about 43.0% and 47.8% in India, respectively. Many factors can contribute to sexual dysfunction in men, including age, lower education, socioeconomic status, stress, perceived health, comorbidities and the medications used to treat them. Physical and psychological stress plays a crucial role in SD. In modern life, majority of the people are experiencing physical stress due to their targets, deadlines, long working hours, night duties, and travel responsibilities in various professions ranging from information technology to pharmaceutical promotion.
In stress induced low vitality, appropriate psychological evaluation is important in addition to appropriate medical treatment. The important treatment strategies such as distraction, physical activities, relaxation, socialising and healthy food, may be employed in order to get out of the stressful situation. Cognitive-behavioural approach and relaxation training plays a vital role in stress induced sexual dysfunction. Previous studies demonstrated that use of antipsychotics in patients with sexual dysfunction results in development of hyperprolactinemia. Dose reduction or use of prolactin-sparing drugs are recommended in those patients. Although, PDE5 inhibitors should be contraindicated in men who are on nitrates and alpha for postural hypotension may be a problem. Therefore, effective prevention and management of sexual dysfunction caused by various risk factors is important in clinical practice.Sexual dysfunction can be managed using herbal medicines/ nutraceuticals, due to their long history of utilization; moreover, natural products have gained increasing interest for maintaining good health worldwide. Therefore, the aim of the present is to assess the effect of nutraceutical products in stress induced low vitality in men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects aged ≥ 18 years and ≤ 60 years.
- •Subjects who are experiencing mild to moderate stress; stress score ≥15 to ≤ 25 as per 21 item Depression, Anxiety, Stress Scale (DASS-21) at screening
- •Subjects with score 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.
- •Subjects should be in an active stable sexual relationship for the entire duration of study
- •Subjects willing to provide informed written consent.
排除标准
- •Subjects with significant medical/surgical condition which requires long-term treatment.
- •Subjects with anatomical abnormalities of the penis.
- •Subjects who are currently being treated with other anti-stress and/or erectile dysfunction drugs.
- •Alcohol or substance abuse
- •Allergy or sensitivity to any of the ingredients in the study treatment
- •Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.
- •Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.
结局指标
主要结局
DASS-21 score documented in the CRF at baseline, day 15, and day 30 (values and change from baseline - within the group and between the groups comparisons)
时间窗: baseline, day 15, and day 30
次要结局
- 36 item Short Form Survey (SF-36) domain scores documented in the CRF at baseline and day 30 (values and change from baseline - within the group and between the groups comparisons)(baseline and day 30)
- Serum Testosterone levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)(baseline and day 30)
- International Index of Erectile Function (IIEF) domain scores documented in the CRF at baseline and day 30 (values and change from baseline - within the group and between the groups comparisons)(baseline and day 30)
- Serum Cortisol levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)(baseline and day 30)