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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean change in hormonal levels
研究概览
简要总结
This is a randomized (1:1), double-blind, two arm, placebo-controlled clinicalstudy. Middle aged male subjects meeting all inclusion criteria and no exclusioncriteria will sign a written informed consent and will be enrolled in the study.After passing the eligibility criteria, subjects will be randomized into 2 treatment arms in a 1:1 ratio, toreceive ABE-0520 or placebo, twice a day, after breakfast and dinner, for a period of12 weeks (84 days).The subject will arrive at the study site early morning in a fasted state and blood samples will becollected for laboratory assessments.Post sample collection, the subjects will be administrated questionnaires to assess the androgen deficiency symptoms, stress, fatigue, sexual function, mood,Sleep and quality of life, The study is planned to be conducted in 4 visits over a period of 84 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •Subjects with morning total testosterone level less than 300 ng/dL and confirming by repeating measurement of total testosterone level.
- •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
- •Non-smoker
- •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
- •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.
- •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
- •Subjects undergone any treatment/ therapy for any sexual disorder during last 6 months
- •Subjects having symptoms of viral infection, including COVID-19 infection
- •Subjects with known hypersensitivity to Ashwagandha extract
- •History of smoking, alcohol/drug abuse
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- •Any condition that in opinion of the Investigator, does not justify the subject’s participation in the study.
- •Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Mean change in hormonal levels
时间窗: Day 0, Day 42, Day 84
次要结局
- Changes in Immunity biomarker levels(Day 0, Day 42, Day 84)
- Changes in Questionnaire based assessments(Day 0, Day 42, Day 84)