CTRI/2023/03/050315进行中（未招募）不适用
Efficacy of TESNOR Supplementation on Libido, Sexual Function and Symptoms of Testosterone Decline in Aging Males.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Derogatis interview for sexual functioning-Self Report-Male (DISF-SR-M)
研究概览
简要总结
The purpose of this studyis to evaluate the efficacy of TESNOR supplementation on libido, sexualfunction and symptoms of Testosterone decline in aging males. Enrolled subjectswill receive either LN18178 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy males aged between 40-70 years with a Body Mass Index (BMI) of 20-29 kg/m
- •Male subjects with Erectile function domain of IIEF score between 17 and
- •Sexual desire domain (Q.11 and Q.12) of IIEF score of <3 each.
- •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.
- •Subjects agreed to refrain from drinking coffee or caffeinated drinks or beverages 24 hrs before the evaluation days.
- •Subjects with total testosterone ≥300 ng/dL.
- •Subjects who are recreationally active.
- •Subjects who are in a stable sexual relationship and sexually active during the study.
- •Subjects agree to maintain current diet and activity level.
- •Subject considered generally healthy as per the investigator opinion from health history and routine clinical investigations.
- •Subjects willing to follow an approved birth control measure; if partner has childbearing potential.
- •Subject should provide written informed consent and agree to be available throughout the study duration for follow-ups.
- •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
- •Subjects with blood pressure >140/90 mmHg, fasting plasma glucose >125 mg/dL and abnormal ECG.
- •Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- •Subject with any physical disability that may limit sexual function or erectile dysfunction.
- •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.
- •Subjects with clinical history of genital surgery, endocrine disorders e.g. hypopituitarism, pituitary tumors, hypo- and hyperthyroidism, hypogonadism, inherited (genetic and chromosomal) disorders, etc.
- •Subjects diagnosed with sleep apnea or related disorders.
- •Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
- •History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Subjects consuming alcohol (>3 standard drinks per week) or smokers (>3 cigarettes per day).
- •Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
- •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.
- •Subjects under medications including anti-hypertensives, antidepressants, anticholinergics, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc.
- •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.
- •Subjects who underwent major surgical procedures in last 6 months.
- •Subject with HIV positive or any other STDs.
- •Subject has participated in a clinical study within the last 30 days prior to recruitment or concurrently participating in another study.
结局指标
主要结局
Derogatis interview for sexual functioning-Self Report-Male (DISF-SR-M)
时间窗: Day 1, Day 14, Day 42 and Day 84
次要结局
- Change from baseline to the end of the study period in Erection hardness score (EHS questionnaire)(Day 1, Day 14, Day 42 and Day 84)
- Change from baseline to the end of the study period inMultidimensional fatigue inventory (MFI-20)(Day 1, Day 42 and Day 84)
- Change from baseline to the end of the study period inInternational index of erectile function (IIEF)(Day 1, Day 14, Day 42 and Day 84)
- Change from baseline to the end of the study period inPittsburgh sleep quality index (PSQI)(Day 1, Day 42 and Day 84)
- Change from baseline to the end of the study period in Six-minute walk test (6MWT)(Day 1, Day 14, Day 42 and Day 84)
- Change from baseline to the end of the study period inGrip strength (using digital hand dynamometer)(Day 1, Day 14, Day 42 and Day 84)
- Change from baseline to the end of the study period in General health survey (on libido, muscle mass, muscle strength, energy, stamina, and sleep)(Day 1, Day 14, Day 42 and Day 84)
研究者
研究点 (2)
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