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CTRI Number  CTRI/2025/03/082855 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 24/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   efficacy and safety of Aceclo MR Tablet in the patients having acute muscular pain associated with spasm. 
Scientific Title of Study   A Prospective Randomized Double blind Comparative Multicenter Phase IV Clinical Trial to evaluate the efficacy and safety of Aceclo MR Tablet Fixed dose combination tablet of Aceclofenac 100mg plus Paracetamol 325 mg plus Chlorzoxazone 500 mg in comparison with Aceclofenac 100mg plus Paracetamol 325 mg in the treatment of acute musculoskeletal pain associated with spasm. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AZ-C-ZIR-19-103 version- 05 Dated-04/03/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manish Maladkar 
Designation  President Medical and Regulatory affairs 
Affiliation  Aristo Pharmaceuticals Private Limited 
Address  Aristo Pharmaceuticals Private Limited 23 A Shah Industrial Estate off Veera Desai road Andheri west

Mumbai (Suburban)
MAHARASHTRA
400053
India 
Phone  02226739999  
Fax    
Email  scientific@aristopharma.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shrikant Patil 
Designation  Senior DGM Medical 
Affiliation  ARISTO Pharmaceuticals private limited. 
Address  Aristo Pharmaceuticals Private Limited 23 A Shah Industrial Estate off Veera Desai road Andheri west

Mumbai (Suburban)
MAHARASHTRA
400053
India 
Phone  02226739999  
Fax    
Email  aepvc.scientific@aristopharma.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Mahendra Chaudhari 
Designation  HOD Clinical Research 
Affiliation  Anazeal Analyticals and research private limited. 
Address  Anazeal Analticals and research Private Limited C 404 ttc Industrial area opp JISL MIDC Pawane Navi mumbai

Thane
MAHARASHTRA
400705
India 
Phone  02269060300  
Fax    
Email  ct1@anazeal.com  
 
Source of Monetary or Material Support  
Aristo Pharmaceuticals Private Limited. 23 A shah Industrial estate off veera desai road Andheri west Mumbai 400053 Maharashtra India. 
 
Primary Sponsor  
Name  Aristo Pharmaceuticals Private Limited 
Address  23 A Shah Industrial Estate off Veera Desai road Andheri west Mumbai 400053 Maharashtra India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dilip Nagarwal  JLN Medical College  JLN Medical College Ajmer Rajasthan India
Ajmer
RAJASTHAN 		 7737258659

kkcrc90@gmail.com 
Dr A Gopal Rao  Government Medical college and govt. General Hospital  Department of Medicine Government Medical college and govt General Hospital Srikakulam Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH 		 9912320517

muralidhargudla@yahoo.com 
Dr Ch V Murali Krishna  Government Medical College and Govt.General Hospital (Old RIMSGGH)  Dept of Orthopedics Government Medical College and Govt General Hospital old RIMSGGH Srikakulam Andhra Pradesh 532001 India
Srikakulam
ANDHRA PRADESH 		 09912320517

muralidhargudla@yahoo.com 
Dr Ajit Kumar Kar  Shanti Memorial Hospital  Shanti Memorial Hospital, Thoria Sahi, Patnaik Colony, Magalbag, Cuttack, Odisha
Cuttack
ORISSA 		 8249935725

ajittapu12@gmail.com 
Dr Manish Dhawan  Sir Gangaram Hospital  Sir Gangaram Hospital SGRH Marg Rajinder Nagar New Delhi 110060 India
New Delhi
DELHI 		 9910104842

vinay2013@gmail.com 
Dr Santosh Jadhav  Sukham Hospital  Sukham Hospital Jasdanwala Complex, Vishrali Naka, MG Road, Panvel, Raigad Maharashtra - 410206 India
Thane
MAHARASHTRA 		 9004657988

santoshjadhav5888@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Sukham Ethics Committee  Approved 
Govt Medical College Govt General Hospital Balaga Srikakulam  Approved 
Govt. Medical College Govt.General Hospital Balaga  Approved 
Jawahar Lal Nehru Medical College  Approved 
Shanti Memorial Hospital Pvt Ltd  Approved 
Sir Gangaram Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aceclo MR  Aceclofenac IP 100mg Plus Paracetamol IP 325mg plus Cholorzoxazone USP 500mg Duration: 7 days 
Comparator Agent  Aceclo Plus  Aceclofenac IP 100mg plus Paracetamol IP 325mg Duration: 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of either gender between 18 and 60 years of age (inclusive of both).
2. Patients of acute musculoskeletal pain with spasm having VAS score ≥ 40 (on 100 mm VAS scale)
3. Patients who are willing to provide written informed consent.
 
 
ExclusionCriteria 
Details  1. Patients with known hypersensitivity to study drugs.
2. History of auto-immune disease.
3. Concurrent use of corticosteroids.
4. Any medication or indication that might point to an increased risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel make the subject inappropriate for inclusion.
5. Participation in other clinical trials the last three months and during study participation.
6. Patients with history of epilepsy, or those at risk of seizures or taking seizure drugs.
7. In pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
8. Patients with galactose or fructose intolerance.
9. Patients with severe renal impairment, including those receiving dialysis.
10. Patients with pre-existing gallbladder disease.
11. Active peptic ulcer disease or history of peptic ulcer, bleeding disorder and fecal blood loss.
12. Patients taking muscle relaxants, NSAIDs (anti-inflammatory drugs) and pain relievers within last 14 days.
13. Patients with significant cardiac, hepatic dysfunction, and hematologic disorder.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of ACECLO MR Tablet Fixed-dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg plus Chlorzoxazone 500mg versus ACECLO PLUS Tablet Fixed dose combination tablet of Aceclofenac 100mg plus Paracetamol 325mg in the treatment of acute musculoskeletal pain associated with spasm.  Visit 1 Day 0 Screening and enrollment.
Visit 2 Day 4 Follow up visit.
Visit 3 Day 7 End of study.
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the safety of ACECLO MR Tablet (Fixed-dose combination tablet of Aceclofenac 100mg + Paracetamol 325mg + Chlorzoxazone 500mg) versus ACECLO PLUS® Tablet (Fixed dose combination tablet of Aceclofenac 100mg +Paracetamol 325mg) in the treatment of acute musculoskeletal pain associated with spasm.

 		 7 days 
 
Target Sample Size   Total Sample Size="260"
Sample Size from India="220" 
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)   30/03/2025 
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="1"
Months="0"
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   “A Prospective, Randomized, Double blind, Comparative, Multicentre, Phase IV Clinical Trial to evaluate the efficacy and safety of Aceclo MR  Tablet (Fixed dose combination tablet of Aceclofenac 100mg + Paracetamol 325 mg + Chlorzoxazone 500 mg) in comparison with Aceclofenac 100mg + Paracetamol 325 mg in the treatment of acute musculoskeletal pain associated with spasm.”

Test product: Aceclo MR Tablet (Fixed-dose combination tablet of Aceclofenac 100mg + Paracetamol 325 mg + Chlorzoxazone 500 mg)

Manufactured by: Aristo Pharmaceuticals Private Limited.

Reference Product: ACECLO PLUS® Tablet (Fixed dose combination tablet of Aceclofenac 100mg + Paracetamol 325 mg).

Primary Objective of the Study

To compare the efficacy of Aceclo MR Tablet (Fixed-dose combination tablet of Aceclofenac 100mg + Paracetamol 325 mg + Chlorzoxazone 500 mg) versus ACECLO PLUS® Tablet (Fixed dose combination tablet of Aceclofenac 100 mg + Paracetamol 325 mg) in the treatment of acute musculoskeletal pain associated with spasm.

Secondary Objective:

To compare the safety of Aceclo MR Tablet (Fixed-dose combination tablet of Aceclofenac 100mg + Paracetamol 325 mg + Chlorzoxazone 500 mg) versus ACECLO PLUS® Tablet (Fixed dose combination tablet of Aceclofenac 100 mg + Paracetamol 325 mg) in the treatment of acute musculoskeletal pain associated with spasm.  

Treatment Duration 7 days ± 2 days.

Study Endpoints

Efficacy:

  • Mean change in pain intensity (100 mm in VAS) from baseline to day 7.
  • Assessment of Muscle spasm scale (3-point scale assessing the severity of spasms ranging from ‘1=mild’ ‘2=moderate’ ‘3=severe’).
         Global assessment of Efficacy by Investigator and Patient

Safety :

·         Any adverse event reported voluntarily, observed or enquired during the study period.

·         Any clinically significant change in the value of laboratory tests, vital signs and physical examination findings during the study compared to baseline.

             Global assessment of Safety by Investigator and Patient.




 
 
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