CTRI/2024/03/064755尚未招募Phase 3 4
A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Comparative Evaluation of TLF-20 on Relevant Sexual Biomarkers in Middle Aged Men with Low Testosterone.
Akay Natural Ingredients Pvt. Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月1日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the effect of the TLF-20 compared to placebo on free testosterone, total testosterone, bioavailable testosterone, sex hormone binding globulin (SHBG), albumin, estradiol (E2), Dehydroepiandrosterone sulfate (DHEA-S) levels.
研究概览
简要总结
This is a randomized (1:1:1), double-blind, active-controlled clinical study. Subjects meeting all inclusion and no exclusion criteria will sign a written informed consent and will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into Placebo, 500mg of TLF-20, and 100mg of TLF-20, respectively for 12 weeks. All assessments will be performed for Baseline, Day 28, Day 56 and Day 84. Blood samples will be collected for safety and biomarker analysis.
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
- 35.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Subjects with morning total testosterone level less than 300 ng/dL
- •Subject with androgen deficiency symptoms assessed by Androgen Deficiency in Aging Male (ADAM) questionnaire items 1 or 7 or any 3 other questions as positive
- •Subjects with Basal Metabolic Index (BMI) greather than 25 Kg per m2
- •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 e.g., depression, anxiety disorder, eating disorder, psychosis/ schizophrenia,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, Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy that contributes to symptoms of low energy or fatigue, Any recent major stressful episodes like surgery, accidents, death in family etc
- •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
- •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 or any disabilities that significantly affect the data collected, such as severe deafness or blindness that may interfere with subject treatment, assessment or compliance with the protocol.
- •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
To evaluate the effect of the TLF-20 compared to placebo on free testosterone, total testosterone, bioavailable testosterone, sex hormone binding globulin (SHBG), albumin, estradiol (E2), Dehydroepiandrosterone sulfate (DHEA-S) levels.
时间窗: Day 0, Day 28, Day 56, Day 84
次要结局
- To assess the safety and efficacy of TLF-20(Day 0, Day 28, Day 56, Day 84)
研究者
Dr Shashank S Gowda
BGS Global Institute of Medical Sciences
研究点 (1)
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