A Single Centric, Open-Label, Non-Randomized Clinical Study to evaluate the Efficacy and Safety of LYCO3 in Male Subjects Suffering from Erectile Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1) Change in International index of erectile function (IIEF) scores from screening to different assessment points.
研究概览
简要总结
A Single Centric, Open-Label, Non-Randomized Clinical Study to evaluate the Efficacy and Safety of LYCO3 in Male Subjects Suffering from Erectile Dysfunction study. Mainly, to assess the safety and efficacy of LYCO3 in the clinical improvement in Erectile Function in male subjects. Study population is total of 20 Male subjects will be enrolled and study duration is 90 days. Individuals with a positive Androgen Deficiency in Aging Males (ADAM) questionnaire score, defined as an affirmative response ("yes") to either of the following questions: "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or a positive response to any three other questions on the ADAM questionnaire and Individuals with an International Index of Erectile Function (IIEF) assessment score between 11-25 will be enrolled into the study. Change in International index of erectile function (IIEF) scores & Change in Erection Hardness Score (EHS) from screening to different assessment points will be assessed. Also, Change in serum testosterone levels from screening to end of the study, Change in ADAM questionnaire score from screening to end of the study, The change in vital signs (blood pressure, pulse rate, body temperature) from screening to the end of the study, The changes in haematological (CBC), liver (Sr. SGPT) and kidney function (serum creatinine) parameters from screening to the end of the study will be assessed. LYCO3, a supplement encapsulating Coenzyme Q10, Lycopene, Tocopherol, Beta-carotene, and Omega-3 Fatty Acids, is formulated to address nutritional deficiencies crucial for overall health. This blend of essential nutrients offers a multifaceted approach to support various bodily functions. By exploring the impact of LYCO3 on erectile function, vascular health, and quality of life, this study aims to contribute valuable insights into novel therapeutic strategies for managing ED and improving sexual health outcomes.
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
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male participants aged above 18 years who are in good health.
- •Participants with a Body Mass Index (BMI) less than
- •Individuals with a positive Androgen Deficiency in Aging Males (ADAM) questionnaire score, defined as an affirmative response ("yes") to either of the following questions: "Do you have a decreased sex drive/libido?" or "Are your erections less strong?" or a positive response to any three other questions on the ADAM questionnaire.
- •Individuals with an International Index of Erectile Function (IIEF) assessment score between 11-
- •Individuals willing to engage in at least four sexual encounters over next 8-week period.
- •Men who are committed to refraining from the use of phosphodiesterase 5 inhibitors (e.g., Viagra, Levitra, Cialis), supplements, or other herbal supplements throughout the study duration.
排除标准
- •Individuals with current or previous history of prostate or testicular cancer.
- •Participants with a past surgical history of prostatectomy.
- •Men who have received past or current treatment for erectile dysfunction, including intracavernosal injections or penile prosthesis.
- •Use of steroids within the past 3 months, including prednisone, cortisone injections, and inhaled steroids.
- •History of or current use of anabolic steroids (e.g., testosterone), testosterone analogs (e.g., DHEA, DHEAS), antidepressants, or anti-androgen medications (e.g., aldactone, tagamet, estrogens).
- •History of spinal cord injury; and use of systemic anticoagulants (e.g., coumadin, clopidogrel).
- •Presence of clinically significant medical conditions, including but not limited to cardiovascular, neurological, psychiatric, hepatic, renal, immunological, endocrine disorders (such as uncontrolled diabetes or thyroid disease), or haematological abnormalities.
- •Active smokers or individuals with a history of high alcohol intake (2 standard drinks per day).
- •Known hypersensitivity to herbal drugs, nutritional supplements, or foods.
结局指标
主要结局
1) Change in International index of erectile function (IIEF) scores from screening to different assessment points.
时间窗: Day 0, Day 45 and Day 90
2) Change in Erection Hardness Score (EHS) from screening to different assessment points.
时间窗: Day 0, Day 45 and Day 90
次要结局
- 1) Change in serum testosterone levels from screening to end of the study.(2) Change in ADAM questionnaire score from screening to end of the study.)
研究者
Dr Srinivas B V
Shridevi Institute of Medical Sciences and Research Center