CTRI/2023/03/050315进行中（未招募）Unknown
Efficacy of TESNOR Supplementation on Libido, Sexual Function and Symptoms of Testosterone Decline in Aging Males.
aila Nutraceuticals0 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
- Unknown
- 状态
- 进行中（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. Healthy males aged between 40-70 years with a Body Mass Index (BMI) of 20-29 kg/m2.
- •2. Male subjects with Erectile function domain of IIEF score between 17 and 25. Sexual desire domain (Q.11 and Q.12) of IIEF score of <3 each.
- •3. Subject agrees to not use supplements including vitamins and minerals or herbals for at least 15 days before screening visit, and for the duration of the study.
- •4. Subjects agreed to refrain from drinking coffee or caffeinated drinks or beverages 24 hrs before the evaluation days.
- •5. Subjects with total testosterone >=300 ng/dL.
- •6. Subjects who are recreationally active.
- •7. Subjects who are in a stable sexual relationship and sexually active during the study.
- •8. Subjects agree to maintain current diet and activity level.
- •9. Subject considered generally healthy as per the investigator opinion from health history and routine clinical investigations.
- •10. Subjects willing to follow an approved birth control measure; if partner has childbearing potential.
- •11. Subject should provide written informed consent and agree to be available throughout the study duration for follow-ups.
- •12. Subject agrees not to start any new therapies for sexual health or energy boosting or protein or testosterone supplements or health drinks during the course of the study.
排除标准
- •1. Subjects with blood pressure >140/90 mmHg, fasting plasma glucose >125 mg/dL and abnormal ECG.
- •2. Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- •3. Subject with any physical disability that may limit sexual function or erectile dysfunction.
- •4. Subjects with history of taking medications for oligospermia or any other sexual problems, including PDE-5 inhibitors, and dysfunctions related to genito-urinary system, muscular dystrophy and coagulation.
- •5. Subjects with clinical history of genital surgery, endocrine disorders e.g. hypopituitarism, pituitary tumors, hypo- and hyperthyroidism, hypogonadism, inherited (genetic and chromosomal) disorders, etc.
- •6. Subjects diagnosed with sleep apnea or related disorders.
- •7. Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
- •8. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •9. Subjects consuming alcohol ( >3 standard drinks per week) or smokers ( >3 cigarettes per day).
- •10. Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
- •11. Subjects having history of Benign Prostate Hyperplasia (BPH), stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months.
- •12. Subjects under medications including anti-hypertensives, antidepressants, anticholinergics, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc.
- •13. Subjects using any centrally acting anorectic agents, drugs that inhibit the absorption of nutrients and endocannabinoid neuromodulators during the two weeks prior to enrolment into the study.
- •14. Subjects who underwent major surgical procedures in last 6 months.
- •15. Subject with HIV positive or any other STDs.
- •16. Subject has participated in a clinical study within the last 30 days prior to recruitment or concurrently participating in another study.
研究者
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