CTRI/2021/01/030391尚未招募未知
A randomized, double-blind, placebo-controlled, clinical study toevaluate the influence of ABE-0520 on vitality and quality of lifeamong healthy middle-aged male subjects characterized with androgen deficiency syndrome.
Akay Natural Ingredients Pvt Ltd0 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
- 未知
- 状态
- 尚未招募
- 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
- •1. Subjects with morning total testosterone level less than 300 ng/dL and confirming by repeating measurement of total testosterone level.
- •2. At screening, subject with androgen deficiency symptoms
- •3.Subjects with no history of surgical or medical castration, diagnosed erectile dysfunction or any physical disability that may limit sexual function
- •4. Non-smoker
- •5. Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
排除标准
- •1. Subjects with history of Uncontrolled diabetes and hypertension,Diagnosable mental health disorder,Cancer, Thyroid diseases, Liver and gall bladder diseases, Renal failure, Chronic fatigue syndrome, Asthma, Cardiovascular disorders, Subjects diagnosed with prostate cancer or benign prostatic hypertrophy, had an acute genitourinary disorder or history of genital surgery.
- •2. Subjects who has been administered any PDE-V inhibitors (sildenafil, tadalafil, or vardenafil) and chemotherapy, corticosteroid, anticoagulation, testosterone, antiandrogen medication within the four weeks prior to enrollment and during the entire course of the study
- •3. Subjects undergone any treatment/ therapy for any sexual disorder during last 6 months
- •4. Subjects having symptoms of viral infection, including COVID-19 infection
- •5. Subjects with known hypersensitivity to Ashwagandha extract
- •6. History of smoking, alcohol/drug abuse
- •7. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •8. History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- •9. Any condition that in opinion of the Investigator, does not justify the subjectâ??s participation in the study.
- •10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
研究者
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