Evaluation of efficacy and safety of EL ED 01 in healthy individuals A Randomized, Double Blind, Placebo Controlled, Multi centric, Interventional, Prospective, Clinical Study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Change in erectile function of penis on Erectile function subscale of IIEF Questionnaire
研究概览
简要总结
It is a randomized, double blind, placebo controlled, multi-centric, interventional, prospective, clinical study to evaluate efficacy and safety of EL/ED/01 in healthy individuals. As per computer generated randomization list subjects will be asked to take given product in a dose of 1 Tablet twice daily orally after meals with water for 30 days. The study will be carried out at 3 to 4 centers in India. The primary objectives of the study will be to assess change in erectile function of penis on Erectile function subscale of IIEF Questionnaire and change in hardness of penis. The secondary objectives of the study will be to assess change in sexual desire, libido and other parameters of IIEF questionnaire, change in male sexual health on EDITS questionnaire, change in quality of penile erection on Quality of Erection Questionnaire, change in quality of Sexual life on Sexual Quality of Life Questionnaire, change in sexual encounter profile as per the recordings, change in premature ejaculation using Premature Ejaculation Profile, change in energy, strength and stamina, global assessment for overall change by investigator and by subjects, tolerability of study products and adverse events, Adverse reactions, and vitals on Day 0, Day 15 and Day 30
Summary of Results:
The study concludes that the use of EL/ED/01 tablets helped to significantly improve erection function, orgasimic satisfaction and intercourse satisfaction over a period of 30 days. There was a significant improvement in penile hardness and premature ejaculation also reduced significant over a period of 30 days use of EL/ED/01 tablets. Quality of sexual life showed significant improvement as reported by the participant as well as the partner. EL/ED/01 tablets consumption was found to be safe without causing any adverse effects.
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 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy participants who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
排除标准
- •Subjects with known major illnesses and sexual dysfunction due to anatomical, surgical, or pharmacological causes
- •History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator.
- •Presence of any drug or therapy that may have relation with ED and sexual dysfunction (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc.)
- •Subjects with total erectile failure
- •Subjects with known hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie disease or penile trauma
- •Subjects with history of disorders that may cause priapism
- •Subjects who are taking any medication for psychiatric disorder
- •Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery
- •Subjects with hypotension or hypertension, diabetes, hepatic impairment, renal impairment, or hematological disorders
- •Subjects who are using and or dependency or failure to keep abstinence for antioxidant agents, vitamins, anti-inflammatory drugs, hormones, Ayurvedic, herbal, homeopathic, naturopathy medications for erectile dysfunction
- •Continuing history of alcohol and or drug abuse
- •Subjects with history of uncontrolled arrhythmia, acute ischemia and known active pulmonary tuberculosis
- •Subjects with significant abnormal laboratory parameters
- •Known cases of varicocele, hydrocele, HIV, AIDS, Hepatitis C and B, Cancer and major debilitating diseases
- •Subject having known hypersensitivity to any ingredient of the study products.
结局指标
主要结局
1. Change in erectile function of penis on Erectile function subscale of IIEF Questionnaire
时间窗: Day 0, Day 15 and Day 30
2. Change in hardness of penis
时间窗: Day 0, Day 15 and Day 30
次要结局
- 1. Change in sexual desire, libido and other parameters of IIEF questionnaire(2. Change in male sexual health on EDITS questionnaire)
研究者
Dr Shailesh V Deshpande
Parul Institute of Ayurveda and Hospital, Parul university