None listed
Conditions
Interventions
Intervention1: LN18178: 400 mg Capsule
once Daily, to be taken orally for 56 Days treatment.
Intervention2: LN18178: 200 mg Capsule
once Daily, to be taken orally for 56 Days treatment.
Control Intervention1: Placebo: Identical
Control Intervention2: Placebo: Identical capsule
once Daily, to be taken orally for 56 Days treatment.
Sponsors
Laila Neutraceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male subjects aged between 36 and 55 years with a Body Mass Index (BMI) between 22 and 29 kg/m2. 2.Subjects with aging malesâ?? symptoms (AMS) total score between 27 and 43. 3.Willingness to walk for 30 min per day (5 days a week) during the course of the study. 4.Subjects should have willing partners; considered generally healthy as per health history and routine clinical investigations. 5.Ability to understand the risks and benefits of the protocol. 6.Subjects who provide written informed consent and agree to be available for regular follow up throughout the study duration. 7.Subjects agree to maintain the activity diary. 8.Subjects who agree not to start any therapies for sexual health or consuming energy boosting supplements or protein supplements or health drinks during the course of the study. 9.Subjects willing to refrain from drinking coffee or caffeinated drinks or beverages during the study.
Exclusion criteria
Exclusion criteria: 1.Subjects with history of taking medications for erectile dysfunction, oligospermia or any other sexual problems, urinary & prostate diseases and muscular dystrophy. 2.Subjects with clinical history of endocrine disorders e.g. hypopituitarism, pituitary tumors, hypo- and hyper-thyroidism, hypogonadism, inherited (genetic and chromosomal) disorders, etc. 3.Subjects diagnosed with sleep apnea or related disorders. 4.Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs. 5.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 6.Subjects consuming alcohol ( >6 standard drinks per week) or smoking. 7.Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products. 8.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 is prohibited. 9.Subjects having history of Benign Prostate Hyperplasia (BPH), hypertension (BP >130/85 mmHg), diabetes (fasting plasma glucose >125mg/dL) stroke, myocardial infarction, coronary artery disease, cardiac failure, angina, life-threatening arrhythmia within the past 6 months. 10.Subjects under medications including anti-hypetensives, inhaled beta agonists, anti-hyperlipidemics, psychotropic etc. 11.Subjects who underwent major surgical procedures in last 6 months. 12.Subjects with HIV positive or any other STDs. 13.Subject has illness as per the opinion of investigator. 14.Subjects 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 in Aging malesâ?? symptoms (AMS) scores from baseline to the end of the study periodTimepoint: Baseline, 7th, 14th, 28th, and 56 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: 1.Total testosterone 2.Free testosterone 3.Estradiol 4.Luteinizing hormone (LH) 5.Dihydrotestosterone (DHT) 6.Cortisol 7.Creatinine 8.Blood urea nitrogen 9.Grip strength 10.Perceived Stress Scale (PSS-10) 11.Endpoints for SafetyTimepoint: 1.Baseline, 7th, 14th, 28th, 56th Day 2.Baseline, 7th, 14th, 28th, 56th Day 3.Baseline, and 56 Days 4.Baseline, and 56 Days 5.Baseline, 7th, 14th, 28th, 56 Day 6.Baseline, 7th, 14th, 28th, 56 Day 7.Baseline, and 56 Days 8.Baseline, and 56 Days 9.Baseline, 7th, 14th, 28th, 56 Day 10.Baseline, 7th, 14th, 28th, 56 Day 11.Baseline, 7th, 14th, 28th, 56 Day | — |
Countries
India
Contacts
Public ContactMr Dheeraj Deep
Laila Nutraceuticals
Outcome results
None listed