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CTRI Number

CTRI/2025/09/095498 [Registered on: 30/09/2025] Trial Registered Prospectively

Last Modified On:

10/11/2025

Post Graduate Thesis

No

Type of Trial

PMS

Type of Study

Nutraceutical

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

A Study Comparing the Effectiveness of Myo Fatige Forte Supplementation and Physiotherapy in Managing Chronic Lower Back Pain

Scientific Title of Study

Comparative Efficacy of Myo Fatige Forte Tablet Palmitoylethanolamide Supplementation over physiotherapy in the management of chronic lower back pain A randomized control Bi centric trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
Nil	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr G Sudhir
Designation	Senior Consultant Spine Surgeon
Affiliation	Sri Ramachandra Institute of Higher Education and Research
Address	Department of Orthopedics Sri Ramachandra Hospital b2 second floor SRMC Block 1 Ramachandra Nagar Porur Chennai Chennai Chennai TAMIL NADU 600116 India
Phone	09962277126
Fax
Email	spinesurgeonsudhir@sriramachandra.edu.in

Details of Contact Person
Scientific Query

Name	Dr G Sudhir
Designation	Senior Consultant Spine Surgeon
Affiliation	Sri Ramachandra Institute of Higher Education and Research
Address	Department of Orthopedics Sri Ramachandra Hospital b2 second floor SRMC Block 1 Ramachandra Nagar Porur Chennai Chennai TAMIL NADU 600116 India
Phone	09962277126
Fax
Email	spinesurgeonsudhir@sriramachandra.edu.in

Details of Contact Person
Public Query

Name	Dr G Sudhir
Designation	Senior Consultant Spine Surgeon
Affiliation	Sri Ramachandra Institute of Higher Education and Research
Address	Department of Orthopedics Sri Ramachandra Hospital b2 second floor SRMC Block 1 Ramachandra Nagar Porur Chennai Chennai TAMIL NADU 600116 India
Phone	09962277126
Fax
Email	spinesurgeonsudhir@sriramachandra.edu.in

Source of Monetary or Material Support

Fourrts India Laboratories Pvt Limited Address 1 Fourrts Avenue Annai Indira Nagar Okkiyam Thoraipakkam Chennai India

Primary Sponsor

Name	Fourrts (India) Laboratories Pvt.Limited
Address	1 Fourrts Avenue Annai Indira Nagar Okkiyam Thoraipakkam Chennai India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sudhir G	Sri Ramachandra Hospital	Department of Orthopedics Sri Ramachandra Hospital b2 second floor SRMC Block 1 Ramachandra Nagar Porur Chennai Chennai TAMIL NADU 600116 India Chennai Chennai TAMIL NADU	09962277126 spinesurgeonsudhir@sriramachandra.edu.in
Dr T V Raja	VISA HOSPITAL	27/1 South West Boag Rd, T Nagar CIT Nagar West T. Nagar Chennai TAMIL NADU Chennai TAMIL NADU	9841038388 drtvraja@gmail.com

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
Institutional Ethics Committee Sri Ramachandra Institute of Higher Education & Research	Approved
Universal Ethics Committee	Submittted/Under Review

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M99-M99\|\|Biomechanical lesions, not elsewhere classified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Conventional physiotherapy group	Intervention: participants will undergo the physical therapy as mentioned by the protocol and will be monitored by the physical therapy instructors. In situation of using any instruments for the physical therapy, the patient will be requested to come in person for the total duration of study Duration: the participants will attend the physical therapy sessions for the entire 12 week study period
Comparator Agent	Myo Fatige Forte tablet and Physiotherapy group	Myo Fatige Forte tablets provided by the study team will be taken once daily. Physical therapy as instructed Duration: participants will continue supplementation and physical therapy for the entire 12 weeks study period
Intervention	Myofatigue Forte Tablets	It is a combination of Palmitoylethanolamide and Acetyl-L-Carnitine which are Nutraceuticals that have demonstrated analgesic and anti-inflammatory properties with no major side effects Dosage:600 MG taken once daily. Administration: oral capsules provided by the study team. Duration: participants will continue supplementation for the entire 12 weeks study period

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Adults aged 18-65 years. Clinical diagnosis of chronic lower back pain lasting more than three months. Minimum pain intensity of 4 on the Visual Analog Scale (VAS) at baseline. Ability to provide informed consent and comply with study protocols Degenerative discs disease without prolapses

ExclusionCriteria

Details

Acute pain conditions or recent injury within the last three months.
History of spinal surgery within the past six months.
Pregnant or breastfeeding women.
Severe comorbidities that could interfere with study outcomes.
Participation in other clinical trials for lower back pain.
Participants with Disc Prolapse, Lysis, Listhesis, Trauma, Tumors, Inflammatory pathologies are excluded.

Method of Generating Random Sequence

Random Number Table

Method of Concealment

An Open list of random numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Change in pain intensity measured by the visual Analog scale (VAS) and questionaries from Week 0 Baseline visit Week 2 In person assessment Week 4 In person assessment Week 6 Telephonic check in Week 8 Inperson assessment Week 10 Telephonic check in Week 12 Final in person assessment This endpoint will help to determine the primary effectiveness of PEA versus physical therapy in alleviating pain.	Change in pain intensity measured by the visual Analog scale (VAS) and questionaries from Week 0 Baseline visit Week 2 In person assessment Week 4 In person assessment Week 6 Telephonic check in Week 8 Inperson assessment Week 10 Telephonic check in Week 12 Final in person assessment This endpoint will help to determine the primary effectiveness of PEA versus physical therapy in alleviating pain.

Secondary Outcome

Outcome	TimePoints
Functional improvement, accessed by the Oswestry disability index (ODI) which evaluates the degree of disability related to lower back pain. Quality of life evaluated, using short form health survey (SF-36), RMDQ which matches health-related quality of life across multiple domains.	Week 0 Baseline visit Week 2 In person assessment Week 4 In person assessment Week 6 Telephonic check in Week 8 In person assessment Week 10 Telephonic check in Week 12 Final in person assessment

Target Sample Size

Total Sample Size="150"
Sample Size from India="150"
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

Post Marketing Surveillance

Date of First Enrollment (India)

13/10/2025

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="3"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

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

Primary objectives

· To evaluate the effectiveness of Myo Fatige Forte Tablet in reducing the pain intensity, compared to physical therapy in patient with chronic lower back pain.

Secondary objectives

· To assess improvement in functional outcomes as measured by the Oswestry Disability index (ODI)

· To evaluate changes in their quality of life as assessed by short form health survey (SF-36)

· To monitor any adverse effects associated with each intervention through participant diaries.

· To assess the overall psychological state during the study period through participant diaries

· To Assess primary care patients with low back pain for prognostic indicators that are relevant to initial decision making (The Keele STarT Back Screening Tool)

· To assess improvement and clinical outcomes using the Roland Morris disability questionnaire for back pain.

Exploratory objective

· To assess the effectives of combination therapy relative to isolated interventions

End points and safety assessment

Primary Endpoints

· Change in pain intensity measured by the visual Analog scale (VAS) and questionaries from baseline to week six and week 12. This endpoint will help to determine the primary effectiveness of Myo Fatige Forte Tablet over physical therapy in alleviating pain.

Secondary endpoints

· Functional improvement, accessed by the Oswestry disability index (ODI) which evaluates the degree of disability related to lower back pain.

· Quality of life evaluated, using short form health survey (SF-36), RMDQ which matches health-related quality of life across multiple domains.

Exploratory endpoints

· Change in pain intensity measured by the visual Analog scale (VAS) and questionaries from baseline to week six and week 12. This endpoint will help to determine the Combined effectiveness of Myo Fatige Forte Tablet as a nutraceutical supplement in aiding the treatment of cLBP with minimal to no side effect.