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CTRI Number  CTRI/2025/04/085094 [Registered on: 17/04/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to evaluate Efficacy and Safety of the 3-Drug Combination (Chlorzoxazone, Paracetamol and Aceclofenac) in comparison with 2-Drug Combination (Paracetamol and Aceclofenac) for treating adult patients with Acute Musculoskeletal Pain Associated with Spasm. 
Scientific Title of Study   A Randomized, Multicenter, Comparative, Open label, Phase-IV study to evaluate safety and efficacy of the 3-Drug-Fixed Dose Combination Tablet of Paracetamol 325 mg, Chlorzoxazone 250 mg and Aceclofenac 100 mg in comparison with Paracetamol 325 mg and Aceclofenac 100 mg Tablet administered BID in adult patients with Acute Musculoskeletal Pain Associated with Spasm. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
BSPL/2023/001 2.0 dated 26-Apr-2024   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunil Maheshwari 
Designation  Senior Consultant Orthopaedic Surgeon 
Affiliation  Prime Care Hospital 
Address  Department of Orthopaedics, B-403/404 Rudra Arcade Near Helmet Cross Road Ahmedabad-380052 Gujarat India.

Ahmadabad
GUJARAT
380052
India 
Phone  9898983555  
Fax    
Email  drsunilmaheshwari10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bharat B Doshi 
Designation  Chief Executive Officer 
Affiliation  BioDev Services Private Limited 
Address  A 804 Privilon Off SG Road ISKCON Ambli Road Ahmedabad GUJARAT 380059 India

Ahmadabad
GUJARAT
380059
India 
Phone  9586244544  
Fax    
Email  bharat.doshi@biodevservices.com  
 
Details of Contact Person
Public Query  
Name  Bharat B Doshi 
Designation  Chief Executive Officer 
Affiliation  BioDev Services Private Limited 
Address  A 804 Privilon Off SG Road ISKCON Ambli Road Ahmedabad GUJARAT 380059 India

Ahmadabad
GUJARAT
380059
India 
Phone  9586244544  
Fax    
Email  bharat.doshi@biodevservices.com  
 
Source of Monetary or Material Support  
Unison Pharmaceuticals Pvt. Ltd. 
 
Primary Sponsor  
Name  Unison Pharmaceuticals Pvt. Ltd. 
Address  “Unison House” Near Prernatirth Derasar Near Ratnadeep II Satellite Jodhpur Ahmedabad 380 015 Gujarat 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 = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravi Garg  Ganesh Shankar Vidyarthi Memorial Medical College  Department of Orthopedic, Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH 		 9793033111

dr_ravi_garg@yahoo.com 
Dr Sunil Maheshwari  Primecare Hospital   Department of Orthopaedics, B-403/404, Rudra Arcade, Near Helmet Cross Road, Ahmedabad- 380052, Gujarat, India
Ahmadabad
GUJARAT 		 9898983555

drsunilmaheshwari10@gmail.com 
Dr Kshitij Shah  Proactive orthopedic clinic   Department of Orthopaedics, Ground floor Juhu Sagar Juhu Versova Link Rd Kapaswadi Andheri West, Mumbai, Maharashtra 400053
Mumbai
MAHARASHTRA 		 9833040048

drkshitij22@gmail.com 
Dr Suraj Pattnayak  Rajiv Gandhi Institute of Medical Sciences and RIMS Govt. General Hospital  Department of Orthopaedics, Research Wing, 2nd Floor, Beside FM Ward, Srikakulam- 532001, Andhra Pradesh
Srikakulam
ANDHRA PRADESH 		 9000268524

drsurajpatnaik@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee, GSVM Medical College  Approved 
Indira IVF Hospital Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Medilink Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Akilos MR  AKILOS MR is the fixed dose combination of Paracetamol,Chlorzoxazone and Aceclofenac. All of them are having anti- inflammatory as well as analgesic effect. The combination of the drugs will help to eliminate the larger dose of the analgesics and yet attain the results. To reduce the pill burden on the patient and increase the patient compliance, the drugs could be given in a fixed dose combination. Hence the study focuses on the safety evaluation of the 3 Drug-FDC in the patients experiencing pain. Dosage regimen in the current study is of 8 days. 
Comparator Agent  Akilos P  Akilos P,2-Drug fixed dose combination of Aceclofenac 100mg + Paracetamol 325 mg (Oral Tablet, BID) is approved for the treatment of acute pain. Dosage regimen in the current study is of 8 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  01. Patients who have given their written consent to participate voluntarily and understand to adhere to protocol for completion of study.

02. Age 18.00 Years to 65.00 Years (inclusive both).

03. Patient is able to take oral medication and willing to adhere to schedule of treatment.

04.Patient’s willingness to comply with all study procedures and availability for the duration of the study.

05. If male, must agree to use a reliable contraception method (i.e., abstinence, condom or partner using an IUD)

06. If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e., abstinence, intrauterine device [IUD], or partner agreeing to use male-condom).

07.Patients diagnosed (by the treating physician/PI) to have acute pain of musculoskeletal nature and as self-rated by the patient 7 to 10 on Numerical pain scale

08. Patients must agree to not consume Alcohol, any other substance of abuse during their participation in the trial.  
 
ExclusionCriteria 
Details  1.Active participation in any other clinical trial.

2.Known allergy to the study drugs used in the trial. (Chlorzoxazone,Paracetamol, Aceclofenac).

3.Patients with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal,neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy, as judged by the investigator.

4.History of auto-immune disease.

5.Patients with the history of epilepsy, or those at risk of seizures, or taking seizure drugs.

6.Pregnant females, lactating women or women of childbearing age who are not using an acceptable method of birth control.

7.Patients with galactose or fructose intolerance.

8. Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.

9.Patients with pre-existing gallbladder disease.

10.Active peptic ulcer disease.

11. Patients taking any other medicines that might interact with one of the study medications.

12. Patient with known G6PD deficiency

13.Alcohol dependence, chronic malnutrition or dehydration, severe hypovolaemia (IV) or any other condition which may interfere with
the study, as judged by the Investigator.

14.Patients with concomitant use of other NSAIDs,antiplatelets, anticoagulants or any other aid for pain.

15.Patients needing any treatment (associated with muscle spasm) other than the study drugs - as diagnosed by the Investigator.

16. Any history/ symptoms/ suspicion of patients having hepatic or renal impairment, as judged by the Principal Investigator.

17.If patient is on any other treatment or additional treatment aid for pain (oral, dermal, drug-plaster, heat-pad or any similar contact
therapy, herbal, homeopathic or any other nature) during the study duration.

18. Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the patient participation in the study. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Percentage of patients who shows any incidence of drug associated adverse effect.
2.Percentage of patients where the PI needs to stop the treatment before day 8 due to drug associated toxicity. 		 8 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Percentage reduction in pain at day 8.
2.Percentage of the patients where the PI stops the treatment before the day 8, as the pain has subsided & the need for pain management does not exist anymore. 		 8 Days 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   28/04/2025 
Date of Study Completion (India) 06/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 Randomized, Multicenter, Comparative, Open label, Phase-IV study to evaluate safety and efficacy of the 3-Drug-Fixed Dose Combination Tablet of Paracetamol 325 mg, Chlorzoxazone 250 mg and Aceclofenac 100 mg in comparison with Paracetamol 325 mg and Aceclofenac 100 mg Tablet administered BID in adult patients with Acute Musculoskeletal Pain associated with spasm. 200 subjects (adult male/female patients of age between 18-65 years) having moderate to severe pain, who are diagnosed by rating the pain between grade 7 to 10 on numeric pain scale by principal investigator, would be screened for enrolment, as per Inclusion/Exclusion criteria. Assessment of efficacy will be done by Numeric Pain Scale by making three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours. The average of the 3 ratings will be used to represent the patient’s level of pain over the previous 24 hours.
 
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