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CTRI Number  CTRI/2010/091/000077 [Registered on: 12/03/2010]
Last Modified On: 21/03/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study
Modification(s)  		 A clinical trial to study the effects of Eperisone SR in patients suffering from acute muscle spasms. 
Scientific Title of Study
Modification(s)  		 A prospective, active-controlled, randomized, double blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of Eperisone SR (150 mg)in patients suffering from acute muscle spasms. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
EP/TML/06/09  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Chandrakant Thorat Dr Harshad G Argekar 
Designation   
Affiliation   
Address  Dr. Thorat, Dept. of Orthopaedics, Government Medical College, Aurangabad - 431 003
Dr. Argekar, Dept. of Orthopaedic, Criticare Hospital & Research Centre, Plot No. 38/39, Main Gulmohar Road, J.V.P.D. Scheme, Andheri (West), Mumbai
Mumbai
MAHARASHTRA
431 003 & 400 049
India 
Phone  09820654780  
Fax    
Email  argekar@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Chandrakant Thorat Dr Harshad Argekar 
Designation   
Affiliation   
Address  Government Medical College, Aurangabad
Criticare Hospital, Plot No. 38/39, Main Gulmohar Road, J.V.P.D. Scheme, Andheri (West)
Mumbai
MAHARASHTRA
431 003 & 400 049
India 
Phone  09820654780  
Fax    
Email  argekar@gmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Sumedh M Gaikwad 
Designation  Director - Medical Services 
Affiliation   
Address  Themis Medicare Limited
11/12, Udyog Nagar, S. V. Road, Goregaon (West)
Mumbai
MAHARASHTRA
400 104
India 
Phone  67603333  
Fax  67607070  
Email  sumedh.gaikwad@themismedicare.com  
 
Source of Monetary or Material Support
Modification(s)  
Themis Medicare Limited 
 
Primary Sponsor
Modification(s)  
Name  Themis Medicare Limited 
Address  11/12, Udyog Nagar, S. V. Road, Goregaon (West), Mumbai - 400 104 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
NIL   
 
Countries of Recruitment
Modification(s)  		   India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshad Argekar  Criticare Hospital & Research Centre  Plot No. 38/39, Main Gulmohar Road,,J.V.P.D. Scheme, Andheri (West)-400 049
Mumbai
MAHARASHTRA 		 9820654780

argekar@gmail.com 
Dr. Chandrakant Thorat  Government Medical College  Dept. of Orthopaedic,-431 003
Aurangabad
BIHAR 		 09422202702

drcrt2007@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Independent Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Acute Muscle Spasms,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Eperisone   Immediate Release (50 mg - 3 times a day for maximum of 10 days) 
Intervention  Eperisone   Sustained Release (150 mg - once a day for maximum of 10 days) 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients of either sex in the age group between 18 to 70 years.
2. Patients painful muscle spasms and contractions associated with cervical and lumbar spondylosis, rheumatoid arthritis, osteoarthritis, blunt superficial trauma, low back pain.
3. Subjects who provide a written informed consent to abide by the study requirements. 
 
ExclusionCriteria 
Details  1. Patients with acute muscle spasms who need parenteral therapy / surgery / hospital admission for management. 2. Patients treated with any other oral / parenteral muscle relaxants, analgesics (NSAIDs & Opioids) medications within 1 week prior to the study. 3. Patients suffering from organic neurological disorders (Upper motor neuron disorders, cerebral palsy, pyramid tract injury, multiple sclerosis, cerebrovascular events, myelopathy, encephalomyelitis, etc), peripheral vascular diseases (arteriosclerosis obliterans, diabetic angiopathy, thrombangiitis obliterans, Raynaud's disease, diffuse scleroderma) as well as syndromes developing on the basis of impaired vascular innervation (acrocyanosis, dysbasia angioneurotica intermittent), Little's diseases and other encephalopathies accompanied by dystonia. 4. Patients suffering from myasthenia gravis or myopathies with muscle weakness as the prominent symptom. 5. Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation. 6. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases. 7. Pregnant and lactating females. 8. Simultaneous participation in another clinical study. 
 
Method of Generating Random Sequence
Modification(s)  		 Computer generated randomization 
Method of Concealment
Modification(s)  		 Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking
Modification(s)  		 Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Pain intensity, tenderness, Joint mobility, Spasm relief, Need for rescue medication, Time needed for the patient to be symptom free  0, 3 days, 7 days, 10 days  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size
Modification(s)  		 Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  		 Phase 3 
Date of First Enrollment (India)
Modification(s)  		 27/01/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  27/01/2010 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 1.Ábrányi,I.(1977)The Myoto-nolytic Effect of Mydocalm Injectable Solution Studied with Double Blind Method. Internal Study Report RGD 12022 2.Szobor,A.(1991)Mydocalm: 30 Years in Therapy. Gyógyszereink 41:110-117. RGD 42475 3.Blazsó, S.(1962) New Possibilities for the Therapy of Various Forms of Childhood Encephalopahty with 1-Piperidino-2-Methyl-3, P-Tolyl-Propane-3 Mydocalm. La Presse Medicale 9 Juin, 1393-1396. RGD 2036 4.S.Inoue et al Mechanisms of action of eperisone on isolated dog saphenous arteries and veins, Jpn J Pharmacol. 1989 Jul;5(3) :271-82 5.Sakai Y et al, The effect of muscle relaxant on the paraspinal muscle blood flow: a randomized controlled trial in patients with chronic low back pain. Spine. 2008 Mar 15;33(6):581-7 6.Bose, K. The efficacy and safety of eperisone in patients with cervical spondylosis: Results of a randomized, double-blind, placebo-controlled trial Methods Find Exp Clin Pharmacol 1999, 21(3): 209 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 A prospective, active - controlled, randomized, double blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of Eperisone Sustained Release (150 mg) in patients suffering from acute muscle spasms. (200 PATIENTS ENROLLED) 
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