CTRI/2022/11/047501已完成未知
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Clinical Study to Evaluate the Efficacy of KSM-66 Ashwagandha® capsule (300 mg) for Improving Sexual Health in Healthy Men
Ixoreal Biomed0 个研究点目标入组 76 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 76
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
- •1.Male participants between 30 to 50 years of age having poor sexual satisfaction based on his own perception since at least past 3 months.
- •2.Participants whose IIEF-EF domain score is between 11 to 16 (i.e. moderately
- •3.Participants in a stable, monogamous behaviour and heterosexual relationship.
- •4.Participants who are willing to stay away from any other medicines or treatments for
- •Erectile Dysfunction (ED) during this study period.
- •5.Participants who are willing to have 4 or more attempts of sexual intercourse each
- •6.Participants who are willing to take proper contraceptives during the study and within
- •3 months after the study completed.
- •7.Participants who have voluntarily decided to participate in this study and signed the
- •informed consent form.
- •8.Participants having sufficient understanding to communicate effectively with the
- •investigator and are willing to discuss their sexual functioning with the investigative
- •9.Participants who are reliable, honest, compliant, and agree to cooperate with all trial
- •evaluations as well as to be able to perform them as per investigatorâ??s opinion.
- •10.Participants willing to follow the protocol requirements and agree to take an
- •investigational product till Day 56 ± 3.
排除标准
- •1. Participants on any medication or supplement (e.g., ginseng, Sildenafil, vardenafil, tadalafil, avanafil) for improving the sexual function during the 3 months prior to study commencement.
- •2. Participants having any clinically significant medical history, medical finding or an on-going medical or psychiatric condition or any acute illness which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- •3. Individuals participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements (for improving the sexual function during the 3 months prior to study commencement).
- •4. Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses).
- •5. Participants with anatomical malformations of the penis.
- •6. Participants with primary hypoactive sexual desire.
- •7. Participants with ED, which is caused by any other primary sexual disorder, like hypopituitarism, hypothyroidism, or hypogonadism.
- •8. Participants who have a spinal injury or have had a radical prostatectomy
- •9. Participants with ED, which is caused by the failure of surgery in the pelvic cavity.
- •10. Participants with penis deformity or penile implants.
- •11. Participants with a history of malignancy.
- •12. Participants with a major refractory psychiatric disorder or significant neurological abnormalities.
- •13. Participants with alcohol addiction or persistent abuse of drugs of dependence.
- •14. Participants who are participating or discontinued participation in the past 3 months from any other clinical trial or are planning to father a baby or are in a relationship with a pregnant partner.
研究者
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