| CTRI Number |
CTRI/2025/06/088873 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate the analgesic effect of LI13108F in healthy subjects with Musculoskeletal pain |
|
Scientific Title of Study
|
A randomized, double blind, placebo-controlled study to evaluate the analgesic effect of LI13108F among healthy subjects with Musculoskeletal pain. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LN/MP/LI13108F/24 Protocol Version 1.0 Dated 23rd Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Prasad |
| Designation |
Overall Trial Coordinator |
| Affiliation |
Aastha Lok Hospital |
| Address |
Room 1, Ground Floor, N/4, near Kendriya Vidyalaya Road, Professor Colony, Jogipur, Kankarbagh, Bankman Colony
Patna
BIHAR
800020
India |
| Phone |
9835607881 |
| Fax |
|
| Email |
drmahesh25d@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Golakoti Trimurthulu |
| Designation |
Senior Vice President Technical |
| Affiliation |
LAILA NUTRA PRIVATE LIMITED |
| Address |
D.No.40-15-14,Sudarsan Apartment,Brindavan Colony, Vijayawada (Urban)
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
08666626666 |
| Fax |
08662546216 |
| Email |
drgt@lailanutra.com |
|
Details of Contact Person
Public Query
|
| Name |
Alluri Venkatakrishna Raju |
| Designation |
General Manager |
| Affiliation |
LAILA NUTRA PRIVATE LIMITED |
| Address |
D.No.40-15-14,Sudarsan Apartment,Brindavan Colony, Vijayawada (Urban)
Krishna
ANDHRA PRADESH
520010
India |
| Phone |
08666626666 |
| Fax |
08662546216 |
| Email |
avkr@lailanutra.com |
|
|
Source of Monetary or Material Support
|
| Laila Nutra Private Limited,D.No.40-15-14,Sudarsan Apartment,Brindavan Colony,Vijayawada (Urban), Krishna- 520010, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Laila Nutra Private Limited |
| Address |
D.No.40-15-14,Sudarsan Apartment,Brindavan Colony,Vijayawada (Urban), Krishna- 520010, Andhra Pradesh |
| Type of Sponsor |
Other [Nutraceutical 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 Mahesh Prasad MBBS MS Orthopedics |
Aastha Lok Hospital |
N/4, near Kendriya Vidyalaya Road, Professor Colony, Jogipur, Kankarbagh, Bankman Colony
Patna
BIHAR |
9835607881
drmahesh25d@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Ram Hospital and Research Centre Private Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Musculoskeletal Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LI13108F – 100 mg |
On day 3, one capsule in the morning after breakfast with water |
| Intervention |
LI13108F – 200 mg |
On day 3, one capsule in the morning after breakfast with water |
| Comparator Agent |
Placebo |
On day 3, one capsule in the morning after breakfast with water |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Untrained, active, healthy, male and female ambulatory subjects (not involved in any kind of physical exercise protocols; involved in day-to-day regular activities) aged between 25 and 45 years with BMI of 20 to 29.9 kg/m2.
2.Willing to participate in a recommended eccentric exercise program of upper arm (elbow flexor) during specified visit.
3.Subjects who are not nutritionally deprived or malnourished as per Mini Nutritional Assessment (MNA-SF) score.
4.Subjects who are not receiving NSAID/analgesic therapy/ nutritional supplements for muscle pain.
5.Subjects who are non-smokers and non-alcohol user.
6.Female subjects of childbearing potential must be using a medically acceptable form of birth control e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit.
7.Subjects with clinical lab observations within normal range or considered not clinically significant by the principal investigator.
8.Subject willing to provide written informed consent and agree to be available for regular follow up throughout the study duration.
9.Willing to keep dietary records.
|
|
| ExclusionCriteria |
| Details |
1.History of OA or RA or any joint disorder.
2.Medical history of upper limb injury in the past six months.
3.History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections.
4.Subjects who are diabetic and/or hypertensive.
5.Subjects on nutritional supplement or herbal product since last one month.
6.Enrolment in another investigational study or intake of investigational drug within the previous three months.
7.Physical therapy treatment during the last 3 months
8.Any abnormal clinical laboratory test results or vital signs considered clinically significant in the opinion of the Investigator
9.Subjects with HIV Positive.
10.Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.)
11.Suspected or known allergy to any components of the study supplement.
12.Women who are pregnant, lactating or planning to become pregnant.
13.Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the 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 the baseline to end trial period in Pain intensity during eccentric movement (using VAS 100 mm scale) |
(At Pre-dose and 1, 2, 3 & 5 hours post supplementation) on day 3. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from the baseline to end trial period in Pain pressure threshold (Pressure algometry) of biceps brachii at 5, 9, and 13 cm above the elbow crease |
(Pre-dose, 1, 2, 3, and 5 hours post dosing) on day 3 |
| Change from the baseline to end trial period in Range of Motion (ROM) |
(Pre-dose, 1, 2, 3, and 5 hours post dosing) on day 3 |
| Change from the baseline to end trial period in Use of Rescue medication. |
Baseline to End of the study |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/06/2025 |
| 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="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 this study is to evaluate the efficacy of LI13108F in alleviating musculoskeletal pain. A total of 120 (40 in each group) Male and female subjects aged between 25 and 45 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 LI13108F - 100mg, LI13108F - 200mg or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast on day 3. A part from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LI13108F will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention. |