| CTRI Number |
CTRI/2025/07/091371 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of LN18178 in improving muscle strength, aerobic capacity and body composition in healthy young males. |
|
Scientific Title of Study
|
A randomized, double blind, placebo controlled parallel arm clinical study to evaluate the efficacy of LN18178 in improving muscle strength, aerobic capacity and body composition in healthy young males. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GNC/MS/LN18178/25 Version 01 20-Jan-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashutosh Mishra |
| Designation |
Principal Investigator |
| Affiliation |
Panacea Hospital and Diabetes Care Organization |
| Address |
OPD No. 1, Ground Floor, Department of Medicine,
B36/44 B-4, Kabir Nagar, Durgakund, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9554572190 |
| Fax |
|
| Email |
dramishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Golakoti Trimurtulu |
| Designation |
Senior Vice President Technical |
| Affiliation |
Laila Nutra Private Limited |
| Address |
Room No 13 Ground Floor R&D Block Survey No 181 by 2 JRD Tata Industrial Estate Kanuru,
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
|
| Email |
drgt@lailanutra.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr A V Krishna Raju |
| Designation |
General Manager–R & D |
| Affiliation |
Laila Nutra Private Limited |
| Address |
Room No 17 Ground Floor R&D Block Survey No 181 by 2 JRD Tata Industrial Estate Kanuru,
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
08666636666 |
| Fax |
|
| Email |
avkr@lailanutra.com |
|
|
Source of Monetary or Material Support
|
| GENCOR lifestage solutions |
|
|
Primary Sponsor
|
| Name |
GENCOR lifestage solutions |
| Address |
7801 N Lamar Blvd,
Suite E210, Austin, Texas 78752, US. |
| Type of Sponsor |
Other [Nutraceuticals] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Laila Nutra Private Limited |
D.No.40-15-14,Sudarsan Apartment, Brindavan Colony, Chandramoulipuram, Vijayawada (Urban), Krishna- 520010, Andhra Pradesh, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashutosh Mishra |
Panacea Hospital and Diabetes Care Organization |
B36/44 B-4, Kabir Nagar, Durgakund,
Varanasi
UTTAR PRADESH |
9554572190
dramishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shivnath Hospital Private Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy ageing males |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LN18178 (400 mg) |
One capsule to be consumed in the morning after breakfast with water for 12 weeks |
| Comparator Agent |
Placebo |
One capsule to be consumed in the morning after breakfast with water for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
36.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Untrained healthy male subjects aged between 36 and 50 years with a Body Mass Index (BMI) between 22 and 27 kg/m2.
2. Willingness to do exercise training program during the course of the study.
3. Subject considered generally healthy as per health history and routine clinical investigations.
4. Ability to understand the risks and benefits of the protocol.
5. Subject should provide written informed consent and agree to be available for regular follow up throughout the study duration.
6. Subjects who are sexually active must agree to use adequate non-hormonal contraception during the study
7. Subjects agree to maintain current diet and activity level.
8. Subject agrees not to start any new therapies for 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 who are resistance trained or undergoing resistance training.
2. Subjects with blood pressure more than or equal to 140/90 mmHg, fasting plasma glucose more than 125 mg/dL and abnormal ECG.
3. Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
4. Evidence or history of musculoskeletal, respiratory, haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
5. Subjects diagnosed with sleep apnea or related disorders.
6. Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
7. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
8. Subjects consuming alcohol (more than 3 standard drinks per week) or smokers ( more than 3 cigarettes per day).
9. Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
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 history of 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 in Muscle strength (1-RM leg press) |
Week 0, Week 2, Week 4, Week 8 and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Muscle strength ( 1-RM bench press) |
Week 0, Week 2, Week 4, Week 8 and Week 12 |
| Change in Muscle endurance (Repetitions to failure for leg press and bench press using 80% 1RM) |
Week 0, Week 2, Week 4, Week 8 and Week 12 |
| Change in training volume/capacity |
Week 0, Week 2, Week 4, Week 8 and Week 12 |
| Change in VO2 max testing (graded exercise test while O2 consumption measured) |
Week 0 and Week 12 |
| Change in Lean body mass (DEXA) |
Week 0 and Week 12 |
| Change in Rate of Perceived Exertion (RPE) using 6-20 point borg scale for exercise intensity |
Week 0, Week 2, Week 4, Week 8 and Week 12 |
| Change in subjective rating of Energy, Fatigue, Focus and Confidence using VAS |
Week 0, Week 2, Week 4, Week 8 and Week 12 |
| Change in subjective feeling of mental acuity, concentration, calmness and quality of sleep using VAS |
Week 0, Week 2, Week 4, Week 8 and Week 12 |
| Change in Physical Activity Enjoyment Scale-8 (PACES) |
Week 0, Week 2, Week 4, Week 8 and Week 12 |
| Change in Serum biomarkers (IGF-1 and Myostatin) |
Week 0 and Week 12 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Purpose of the study is to evaluate the efficacy of LN18178 in improving muscle strength, aerobic capacity and body composition in healthy young males. A total of 120 male subjects aged between 36 and 50 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either LN18178:400 mg or Placebo arm at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast with water for 12 weeks. Apart from primary and secondary outcomes, the study will also record the vital sign and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LN18178 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention. |