None listed
Conditions
Interventions
Intervention1: LN18178 200 mg: 1 capsule to be taken daily in
the morning after breakfast for
56 days
Intervention2: LN18178 400 mg: 1 capsule to be taken daily in
the morning after breakfast for
56 d
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: Male subjects aged between 21 and 35 years with a Body Mass Index (BMI) between 20 and 29 kg/m2. Willingness to do 40 min aerobic exercise per day (4 days a week)during the course of the study. Subject considered generally healthy as per health history and routine clinical investigations. Ability to understand the risks and benefits of the protocol. Subject should provide written informed consent and agree to be available for regular follow up throughout the study duration. Subjects agree to maintain the activity diary. Subject agrees not to start any new therapies for sexual health or energy boosting supplements or protein supplements or health drinks during the course of the study. Subjects willing to refrain from drinking coffee or caffeinated drinks or beverages during the study.
Exclusion criteria
Exclusion criteria: Subjects who are resistance trained or undergoing resistance training. Subjects with history of taking medications for erectile dysfunction, oligospermia or any other sexual problems, urinary & prostate diseases and muscular dystrophy. Subjects with clinical history of 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. Subjects who consume recreational drugs (such as cocaine,methamphetamine, marijuana, etc.) or chewable tobacco products. Subjects having history of Benign Prostate Hyperplasia (BPH),hypertension (BP >130/85 mmHg), diabetes (fasting plasma glucose >125 mg/dL), stroke, myocardial infarction, coronary artery disease,cardiac failure, angina, life-threatening arrhythmia within the past 6 months. Subjects under medications including anti-hypertensives, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc. Use of 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 illness as per the opinion of investigator. Subject has participated in a clinical study within the last 90 days prior to recruitment or concurrently participating in another study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Serum testosteroneTimepoint: Day 1,7, 14,28 and 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: Estradiol Luteinizing hormone (LH) Dihydrotestosterone (DHT) Cortisol Grip strength Mid-upper arm circumference (Arm girth)Timepoint: Estradiol and Luteinizing hormone (LH)at Day 1 and 56 Dihydrotestosterone(DHT),Cortisol,Grip strength and Mid-upper arm circumference (Arm girth) at Day 1,7,14,28 and 56 | — |
Countries
India
Contacts
Public ContactMr Prason Kumar
Laila Nutraceuticals
Outcome results
None listed