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CTRI Number  CTRI/2024/12/078403 [Registered on: 20/12/2024] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate Efficacy and Safety of 3-Drug-combination (Serratiopeptidase, Paracetamol and Diclofenac Sodium) in comparison with 2-Drug-combination (Paracetamol and Diclofenac Sodium) in adult patients with Acute Lower Backache associated with Muscle Spasm. 
Scientific Title of Study   A Randomized, Multicenter, Comparative, Phase-IV, Open label study to evaluate Efficacy and Safety of the 3-Drug-Fixed Dose Combination Tablet of Serratiopeptidase 10 mg, Paracetamol 325 mg and Diclofenac Sodium 50 mg in comparison with 2-Drug-Fixed Dose Combination Tablet of Paracetamol 325 mg and Diclofenac Sodium 50 mg administered TID in adult patients with Acute Lower Backache associated with Muscle Spasm 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
BSPL/2023/004 3.0 dated 02-Jan-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  Prime Care Hospital 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  BioDev Services Private Limited A 804, Privilon Off. S. G. 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  BioDev Services Private Limited A 804, Privilon Off. S. G. 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. “Unison House”, Near Prernatirth Derasar, Near Ratnadeep II, Satellite, Jodhpur, Ahmedabad-380 015, Gujarat, India. 
 
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  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandan Kumar  Ganesh Shankar Vidyarthi Memorial Medical College  Ganesh Shankar Vidyarthi Memorial Medical College, Department of Orthopedic, Swaroop Nagar, Kanpur - 208002
Kanpur Nagar
UTTAR PRADESH 		 9335313138

Ck131980@gmail.com 
Dr Paramesha KC  KR Hospital  Mysore Medical College and Investigator Research Institute, Department of Orthopaedics, Irwin Road, Mysuru-570001
Mysore
KARNATAKA 		 9343055819

parameshkennal@gmail.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 
 
Details of Ethics Committee  
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  
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 
Comparator Agent  DAN-P  DAN P, 2-Drug fixed dose combination of Paracetamol 325 mg + Diclofenac sodium 50 mg (Oral Tablet, TID) is approved for the treatment of acute pain. The drug has to be taken as prescribed by the physician till pain subsides. In current study, drug will be taken till day 8 or resolution of symptoms whichever occurs first. 
Intervention  DAN-SP  DAN SP is the fixed dose combination of Paracetamol,Serratiopeptidase and Diclofenac providing anti- inflammatory, analgesic, and anti-pyretic 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. The drug has to be taken as prescribed by the physician till pain subsides. In current study, drug will be taken till day 8 or resolution of symptoms whichever occurs first. 
 
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], orpartner agreeing to use male-condom).
07.Patients diagnosed (by the treating physician/PI) to have Acute Painful musculospastic condition such as prolapsed intervertebral disc, sprains and dislocations, spondylosis (lumbar, cervical, ankylosing spondylosis), spinal stenosis, periarthritis, frozen shoulder, prepatellar bursitis, spondylolisthesis, low-backpain, tendonitis, tenosynovitis, bursitis, 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 or in last three months.
2. Known allergy to the study drugs used in the trial. (Serratiopeptidase, Paracetamol, Diclofenac).
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 seizures or taking seizure drugs in pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
6. Patients with galactose or fructose intolerance.
7. Patients with severe renal impairment, including those receiving dialysis.
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, corticosteroids, antiplatelets, anticoagulants or any other aid for pain.
15. Patients needing any treatment (associated with acute lower backache 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’s participation in the study. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary 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 
 
Secondary 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 
 
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)   01/01/2025 
Date of Study Completion (India) 08/05/2025 
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, Phase-IV, Open label study to evaluate Efficacy and Safety of the 3-Drug-Fixed Dose Combination Tablet of Serratiopeptidase 10 mg, Paracetamol 325 mg and Diclofenac Sodium 50 mg in comparison with 2-Drug-Fixed Dose Combination Tablet of Paracetamol 325 mg and Diclofenac Sodium 50 mg administered TID in adult patients with Acute Lower Backache associated with Muscle Spasm. 200 subjects (adult male/female patients of age Between 18 -65) 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. Age: 18 Years to 65 Years (inclusive of both). Assessment 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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