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CTRI Number  CTRI/2025/02/080968 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Diagnostic
Screening
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check effect of two different drugs i.e. eperisone hydrochloride vs chlorzoxazone to releive muscle pain in head and neck region. 
Scientific Title of Study   To evaluate efficacy and safety of eperisone hydrochloride vs chlorzoxazone in patients with myofascial pain dysfunction syndrome :A randomized controlled double Blinded open labelled 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 Pranali Mohan Mane 
Designation  Post Graduate Student  
Affiliation  D Y Patil School Of Dentistry , Nerul ,Navi Mumbai , 
Address  Department Of Oral Medicine And Radiology, D Y Patil school Of Dentistry, Sector 7, Nerul ,Navi Mumbai.

Thane
MAHARASHTRA
400706
India 
Phone  9137493905  
Fax    
Email  pranalimane3335@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mandavi Waghmare 
Designation  Professor 
Affiliation  D Y Patil School Of Dentistry , Nerul ,Navi Mumbai  
Address  Department Of Oral Medicine And Radiology, Sector 7,Nerul,Navi Mumbai.
Department Of Oral Medicine And Radiology, Sector 7,Nerul,Navi Mumbai.
Thane
MAHARASHTRA
400706
India 
Phone  08108069665  
Fax    
Email  mandavi.waghmare@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Pranali Mohan Mane 
Designation  Post Graduate Student 
Affiliation  D Y Patil School Of Dentistry , Nerul ,Navi Mumbai  
Address  Department Of Oral Medicine And Radiology, Sector 7,Nerul,Navi Mumbai.

Thane
MAHARASHTRA
400706
India 
Phone  9137493905  
Fax    
Email  pranalimane3335@gmail.com  
 
Source of Monetary or Material Support  
School of Dentistry, D Y Patil Deemed to be University, Sector 07,Dr D Y Patil Vidyanagar ,Nerul, Navi Mumbai ,400706 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mandavi Waghmare  D Y Patil School Of Dentistry  Department Of Oral Medicine And Radiology, Sector 7,Nerul,Navi Mumbai.
Thane
MAHARASHTRA 		 8108069665

mandavi.waghmare@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research And Ethical Board D.Y. Patil Deemed To Be University School Of Dentistry ,Navi Mumbai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M624||Contracture of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorzoxazone  Chlorzoxazone Tablet (250mg) for twice a day for 7 days 
Intervention  Eperisone Hydrochloride  Tablet Eperisone hydrochloride (50mg) to be given per day twice for 7days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Patients attending outpatient department both male and female between 20 to 55 yrs.
2.Presence of unilateral pain, muscle tenderness, Clicking or popping noise in the TMJ, Limitation of jaw movement.
3.No radiographic evidence of bony pathology.
4.No tenderness in TMJ area on palpation via the external auditory meatus.
5.Willing to take medications as directed and come for follow up were included.

 
 
ExclusionCriteria 
Details  1.Bilaterally Edentulous arches
2.Pregnant or lactating women
3.Patient with known H/O hypersensitivity to any of the trial drugs
4.Medical disease like suffering from hematologic /endocrine/impaired liver function/kidney disorder.
5.Unwilling to be a part of study
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Benefit in improvement of pain intensity
2.Benefit in duration of pain reduction
3.Improvemet in mouth opening. 		 At baseline,3rd day,5th day,7th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of any adverse Effects  At baseline,7 days 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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 4 
Date of First Enrollment (India)   03/03/2025 
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="0" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pranalimane3335@gmail.com].

  6. For how long will this data be available start date provided 01-11-2025 and end date provided 01-11-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This is Double Blinded Randomized Controlled trial Open Labelled, comparing the efficacy of eperisone hydrochloride (50mg) and Chlorzoxazone (250mg) along with paracetamol twice daily for 7 days  in 28 patients with myofascial  pain dysfunction syndrome in India. The primary outcomes are expected to benefit in improvement in pain intensity ,duration of reduction. They will be assessed at baseline, day 3 ,day 5 and day 7.The secondary outcome will be evaluated as adverse effects at baseline and on 7th day. 
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