| CTRI Number |
CTRI/2023/05/052652 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of LI12542F6 supplementation on Testosterone level and its tolerability |
|
Scientific Title of Study
|
A randomized, double blind, placebo-controlled clinical study to evaluate the effect of LI12542F6 supplementation on Testosterone level and its tolerability in healthy ageing males |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LN/TI/LI12542F6/22 Version 01 Dated 13-Oct-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshith Jain |
| Designation |
Principle Investigator |
| Affiliation |
Jain Clinic |
| Address |
Room No 2, Ground Floor, 8XFWC5G, Vidyapeeth Rd, Below Subhakamana Wedding Hall, Maldahiya, Chetganj
Rameshwar Road Harahua
Varanasi
UTTAR PRADESH
221105
India |
| Phone |
9793036567 |
| Fax |
|
| Email |
harsh656@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Golakoti Trimurthulu |
| Designation |
Senior Vice President Technical |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals
Room No 13 Ground Floor
R & D Block Survey
No 181 by 2 JRD Tata Industrial Estate Kanuru
Vijayawada
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666626666 |
| Fax |
08662546216 |
| Email |
drgt@lailanutra.com |
|
Details of Contact Person
Public Query
|
| Name |
Alluri Venkatakrishna Raju |
| Designation |
General Manager |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals
Room No 17 Ground Floor
R & D Block Survey
No 181 by 2 JRD Tata Industrial Estate Kanuru
Vijayawada
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666626666 |
| Fax |
08662546216 |
| Email |
avkr@lailanutra.com |
|
|
Source of Monetary or Material Support
|
| Laila Nutraceuticals R&D Block Survey No 181 by 2 JRD Tata Industrial Estate Kanuru Vijayawada Krishna District Andhra Pradesh 520007 India |
|
|
Primary Sponsor
|
| Name |
Laila Nutraceuticals |
| Address |
40-15-14, Brindavan Colony, Labbipet Vijayawada-520010 |
| Type of Sponsor |
Other [Nutraceuticals Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshith Jain |
Jain Clinic |
Room No 2, Ground Floor, 8XFWC5G, Vidyapeeth Rd, Below Subhakamana Wedding Hall, Maldahiya, Chetganj, Varanasi, Uttar Pradesh 221002
Varanasi
UTTAR PRADESH |
9793036567
harsh656@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vatsalya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Ageing Males |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: LI12542F6, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 325(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: One capsule (325 mg) daily morning after the breakfast for 56 days administered orally | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 325(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: One capsule (Placebo -325mg) daily morning after the breakfast for 56 days administered orally |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1.Healthy males aged between 40-65 years with a Body Mass Index (BMI) of 22-29 kg/m2.
2.Subjects with total Testosterone levels > 300ng/dL.
3.Subjects who are recreationally active (Participating in any cardiovascular exercise
like cycling, jogging, brisk walking, running, swimming not more than five times weekly) but not participating in resistance training.
4.Subjects agree to maintain current diet and activity level.
5.Subject considered generally healthy as per the investigator opinion from health history and routine clinical investigations.
6.Ability to understand the risks and benefits of the protocol.
7.Subject should provide written informed consent and agree to be available throughout the study duration for follow-ups.
8.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.
9.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
10.Subjects agreed to refrain from drinking coffee or caffeinated drinks or beverages 24hrs before the evaluation days.
|
|
| ExclusionCriteria |
| Details |
1.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
2.Subjects with history of taking medications for erectile dysfunction, oligospermia or any other sexual problems, urinary & prostate diseases and muscular dystrophy.
3.Subjects with clinical history of endocrine disorders e.g. hypopituitarism, pituitary
tumors, hypo- and hyperthyroidism, hypogonadism, inherited (genetic and chromosomal) disorders,etc.
4.Subjects diagnosed with sleep apnea or related disorders.
5.Subjects consuming medications that caninterfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
6.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
7.Subjects consuming alcohol (>3 standard drinks per week) or smokers (>3 cigarettes per day).
8.Subjects who consume recreational drugs (such as cocaine, methamphetamine,
marijuana, etc.) or chewable tobacco products.
9.Subjects having history of Benign Prostate Hyperplasia (BPH), hypertension (BP>140/90 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.
10.Subjects under medications including anti-hypertensives, antidepressants,anticholinergics, inhaled beta agonists,anti-hyperlipidemics, psychotropics etc.
11.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.
12.Subjects who underwent major surgical procedures in last 6 months.
13.Subject with HIV positive or any other STDs.
14.Subject has participated in a clinical study within the last 30 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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study period in Serum total testosterone |
Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study in Grip strength (by using hand dynamometer |
Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56 |
| Change from baseline to the end of the study in Changes in sexual function questionnaire (CSFQ) |
Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56 |
| Change from baseline to the end of the study period in Quality of life questionnaire (SF-36 – Vitality scale only) |
Day 1 (Baseline), Day 28 and Day 56 |
| Change from baseline to the end of the study period in Perceived stress scale (PSS) |
Day 1 (Baseline), Day 28 and Day 56 |
| Change from baseline to the end of the study period in Athens insomnia scale (AIS) |
Day 1 (Baseline), Day 28 and Day 56 |
| Change from baseline to the end of the study period in Chalder fatigue scale (CFQ 11) |
Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56 |
| Change from baseline to the end of the study period in Serum free testosterone |
Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56 |
| Change from baseline to the end of the study period in Dihydrotestosterone (DHT) |
Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56 |
| Change from baseline to the end of the study period in Estradiol |
Day 1 (Baseline) and Day 56 |
| Change from baseline to the end of the study period in Testosterone : Estradiol |
Day 1 (Baseline) and Day 56 |
| Change from baseline to the end of the study period in Cortisol |
Day 1 (Baseline), Day 7, Day 14, Day 28 and Day 56 |
| Change from baseline to the end of the study period in Sex hormone binding globulin (SHBG) |
Day 1 (Baseline) and Day 56 |
| Change from baseline to the end of the study period in Body composition (using DEXA) – including total fat, android fat and gynoid fat |
Day 1 (Baseline) and Day 56 |
| Change from baseline to the end of the study period in DHEA |
Day 1 (Baseline) and Day 56 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "69"
Final Enrollment numbers achieved (India)="69" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/05/2023 |
| Date of Study Completion (India) |
05/09/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to evaluate the effect of LI12542F6 supplementation on Testosterone levels in healthy ageing males. Enrolled subjects will receive either LI12542F6 or placebo daily in the morning for 56 days |