CTRI/2024/01/061831招募中2 期
Evaluation of efficacy and safety of EL ED 01 in healthy individuals A Randomized, Double Blind, Placebo Controlled, Multi centric, Interventional, Prospective, Clinical Study - NI
Emil Pharmaceutical Industries Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •2. History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator.
- •3. Presence of any drug or therapy that may have relation with ED and
- •sexual dysfunction (nitrates, anti-androgens, chemotherapy agents,
- •radiotherapy, etc.)
- •4. Subjects with total erectile failure
- •5. Subjects with known hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie disease or penile trauma
- •6. Subjects with history of disorders that may cause priapism
- •7. Subjects who are taking any medication for psychiatric disorder
- •8. Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery
- •9. Subjects with hypotension or hypertension, diabetes, hepatic impairment, renal impairment, or hematological disorders
- •10. 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
- •11. Subjects with preexisting systemic disease necessitating long-term
- •medications, genetic and endocrinal disorders
- •12. Continuing history of alcohol and or drug abuse
- •13. Subjects with history of uncontrolled arrhythmia, acute ischemia and known active pulmonary tuberculosis
- •14. Subjects with significant abnormal laboratory parameters
- •15. Known cases of varicocele, hydrocele, HIV, AIDS, Hepatitis C and B, Cancer and major debilitating diseases
- •16. Subject having known hypersensitivity to any ingredient of the study products
研究者
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