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CTRI Number  CTRI/2024/04/065501 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 07/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   To study the effects of tolperisone and thiocolchicoside in combination with aceclofenac in females with low back pain 
Scientific Title of Study   To evaluate the clinical outcome of tolperisone and thiocolchicoside in combination with aceclofenac in females with low back pain 
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Daphika Dkhar 
Designation  Post Graduate Resident 
Affiliation  VMMC and Safdarjung Hospital 
Address  Room 27, PMR OPD, Ground Floor, Main OPD Building, VMMC and Safdarjung Hospital

South West
DELHI
110029
India 
Phone  7005635957  
Fax    
Email  daphika000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ajay Gupta 
Designation  Head of department 
Affiliation  VMMC and Safdarjung Hospital 
Address  Room 33, PMR OPD, Ground Floor, Main OPD Building, VMMC and Safdarjung Hospital

South West
DELHI
110029
India 
Phone  9810692375  
Fax    
Email  dragupta2013@gmail.com  
 
Details of Contact Person
Public Query  
Name  Daphika Dkhar 
Designation  Post Graduate Resident 
Affiliation  VMMC and Safdarjung Hospital 
Address  Room 27, PMR OPD, Ground Floor, Main OPD Building, VMMC and Safdarjung Hospital

South West
DELHI
110029
India 
Phone  7005635957  
Fax    
Email  daphika000@gmail.com  
 
Source of Monetary or Material Support  
VMMC and Safdarjung Hospital,Ansari nagar, New Delhi, India 110029 
 
Primary Sponsor  
Name  VMMC and Safdarjung Hospital 
Address  Ansari Nagar, Delhi, India, 110029 
Type of Sponsor  Government medical college 
 
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 Daphika Dkhar  VMMC and Safdarjung hospital   Ground Floor, PMR OPD Room no.27, Main OPD Building, VMMC and Safdarjung Hospital, Delhi,India -110029
South West
DELHI 		 7005635957

daphika000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, VMMC and Safdarjung Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aceclofenac and Tolperisone  Aceclofenac 100mg BD orally and Tolperisone 150mg TDS orally for 7 days or 14 days (wherever applicable) with standard care of treatment 
Comparator Agent  Aceclofenac and Thiocolchicoside  Aceclofenac 100mg BD orally and Thiocolchicoside 4mg TDS orally for 7 days or 14 days (wherever applicable) with standard care of treatment 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  45.00 Day(s)
Gender  Female 
Details  Female patients with non-specific low back pain of age group 18 years to 45 years with BMI 18.5 to 30 having symptoms for less than 12 weeks 
 
ExclusionCriteria 
Details  1. Received skeletal muscle relaxant and NSAIDs during past 1 week
2. Patient with rheumatological disorder
3. Recent history of spinal injections in the past 3 months
4. Gynaecological and obstetric symptoms
5. History of vertebral fracture
6. Contraindication of Aceclofenac, Tolperisone and Thiocolchicoside 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the clinical outcomes of Tolperisone and Thiocolchicoside used in combination with Aceclofenac on female patients with low back pain using
1. Visual Analogue Scale
2. Finger to Floor Distance
3. Oswestry Disability Index 		 Day 0, Day 7, Day 21, Day 42 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate the frequency of relapse and side effect in the study population in 6 weeks of follow up  Day 42 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/04/2024 
Date of Study Completion (India) 01/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [daphika000@gmail.com].

  6. For how long will this data be available start date provided 21-12-2025 and end date provided 21-03-2027?
    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
Modification(s)  		 Low back pain is defined as pain and discomfort localized below the costal margin and above inferior gluteal folds, with or without radiating to the legs.1 According to WHO, Acute low back pain is an episode that persist for less than 6 weeks and Subacute low back pain is pain between 6 to 12 weeks.2 The Global Burden of Disease Study 2016 reported that low back pain (LBP) contributes 57.6 million years lived with disability (YLD).3 The lifetime prevalence in LBP in India was found to be significantly higher in men, about 65% and 57% with women.4  According to WHO, LBP may be classified as specific and non-specific. Non-specific means that the pain experience cannot be account for another disease and is about 90% of cases. Specific LBP can be explained by an underlying disease (cancer, etc) and tissue damage (fracture, etc) or may referred from other organs (from kidney, aortic aneurysm. etc).2 The spasm-pain-spasm cycle suggest that muscle spasm caused by any injury, can induce pain and reduce range of motion. The feeling of pain can cause further muscle contractions that further increase the intensity of pain, resulting in self-perpetuation of the cycle and chronicity of LBP.5,6 According to a Canadian clinical practice guidelines 2015, the treatment recommended in acute and subacute low back pain are education and reassurance, advice to stay active, therapeutic exercise, heat and cold packs. Analgesia is provided by prescribing acetaminophen, NSAIDs, consider adding short course of muscle relaxant like benzodiazepines, cyclobenzaprine or anti-spasticity drugs as short term. Brief course of opioids can be used if pain is not in control with acetaminophen and NSAIDs.7 According to NICE guidelines, 2016 the pharmacological recommendation for treatment of low back pain consists of oral NSAIDs, paracetamol should not be used alone. Weak opioids with or without paracetamol can be used if NSAIDs is contraindicated. 
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