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CTRI Number  CTRI/2019/02/017506 [Registered on: 06/02/2019] Trial Registered Prospectively
Last Modified On: 17/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness and safety of a herbal composition to improve Aging Male Symptoms 
Scientific Title of Study   A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of a Novel Herbal Composition Improving Aging Male Symptoms 
Trial Acronym  AMS Study 
Secondary IDs if Any  
Secondary ID  Identifier 
LN/TB/AM/LN18178/18 Version 01 Dated 07-Aug-2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Venkateshwarlu 
Designation  Consultant, Herbal and Ayurvedic Clinical Trials  
Affiliation  D2L Clinical Solutions Private Ltd 
Address  Nandi Infotech, 1st Floor, KIADB Plot No. 8, 1st Cross, Sadaramangala Industrial Area, Mahadevpura Post, Bengaluru

Bangalore
KARNATAKA
560 048
India 
Phone  9945232107  
Fax    
Email  drvenkatesh64@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr AVK Raju 
Designation  Head-Project Management 
Affiliation  Laila Nutraceuticals 
Address  Survey No. 181/2,181/3, 181/4B, JRD Tata Industrial Estate, Kanuru, Vijayawada

Visakhapatnam
ANDHRA PRADESH
520007
India 
Phone  0866-6636666  
Fax    
Email  avkr@lailanutra.in  
 
Details of Contact Person
Public Query  
Name  Mr Dheeraj Deep 
Designation  Head, Clinical Research 
Affiliation  D2L Clinical Solutions Pvt. Ltd 
Address  Nandi Infotech, 1st Floor, KIADB Plot no.8,1st Cross, Sadaramangala Industrial Area, Mahadevpura Post

Bangalore
KARNATAKA
560 048
India 
Phone  9686861185  
Fax    
Email  dheeraj@d2lclinical.com  
 
Source of Monetary or Material Support  
Laila Neutraceuticals Pvt Ltd Auto Nagar 7th Line, Auto Nagar, Vijayawada, Andhra Pradesh 520007 
 
Primary Sponsor  
Name  Laila Neutraceuticals Pvt Ltd 
Address  Auto Nagar 7th Line, Auto Nagar, Vijayawada, Andhra Pradesh 520007 
Type of Sponsor  Other [Nutraceutical Industry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dayanand Yaligar  Narayana Hrudayalaya  Taluk, Anekal, 258/A, Hosur Rd, Bommasandra Industrial Area, Bengaluru
Bangalore
KARNATAKA 		 08071222222

alben.sigamani.dr@narayanahealth.org 
Dr L Sucharitha   Shetty’s Hospital  Plot No 11 and 12, 12th F Main, Kaveri Nagar
Bangalore
KARNATAKA 		 08026612042

sucharitha.pandit@gmail.com 
Dr Annapoorna bhat  Sri Venkateshwara Hospital  NH 7, Hosur Rd, Zuzuvadi, Madiwala, 1st Stage, BTM Layout-560068
Bangalore
KARNATAKA 		 08040416789

svhethics@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Narayana Health Medical Ethics Committee  Approved 
Shetty’s hospital ethics committee  Approved 
Sri Venkateshwara Hospital ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LN18178  200 mg Capsule; once Daily, to be taken orally for 56 Days treatment. 
Intervention  LN18178  400 mg Capsule; once Daily, to be taken orally for 56 Days treatment. 
Comparator Agent  Placebo  Identical capsule; once Daily, to be taken orally for 56 Days treatment. 
 
Inclusion Criteria  
Age From  36.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  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 males‟ 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. 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Aging males‟ symptoms (AMS) scores from baseline to the end of the study period   Baseline, 7th, 14th, 28th, and 56 Days 
 
Secondary Outcome  
Outcome  TimePoints 
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 Safety 		 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 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/02/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The study outcome will be published by the sponsor after completion of the study.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This proposed study is a randomized, double-blind, placebo-controlled trial, investigating the efficacy and safety of two different doses of LN18178 (200mg, and 400 mg) versus placebo in improving the symptoms of aging in men aged between 36-55 years. The improvement in symptoms will be analysed by the standard scoring system for aging males symptoms and  associated serum bio-markers. 
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