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CTRI Number  CTRI/2022/06/043615 [Registered on: 30/06/2022] Trial Registered Prospectively
Last Modified On: 29/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Therapeutic Patient Education]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Randomised controlled trial for role of patient education in chronic migraine management 
Scientific Title of Study   Efficacy of combination of therapeutic patient education with standard of care versus standard of care alone for the management of chronic migraine: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Debashish Chowdhury 
Designation  Director Professor and Head, Department of Neurology 
Affiliation  GB Pant Institute Postgraduate Medical Education and Research 
Address  Neurology Office 5th floor, Academic Block G.I.P.M.E.R. 1, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi

Central
DELHI
110002
India 
Phone    
Fax    
Email  debashishchowdhury@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mridula Garg 
Designation  M.B.B.S. Student 
Affiliation  GB Pant Institute Postgraduate Medical Education and Research 
Address  Neurology Office 5th floor, Academic Block G.I.P.M.E.R. 1, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi

Central
DELHI
110002
India 
Phone  9811230029  
Fax    
Email  gargmridula7@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mridula Garg 
Designation  M.B.B.S. Student 
Affiliation  GB Pant Institute Postgraduate Medical Education and Research 
Address  Neurology Office 5th floor, Academic Block G.I.P.M.E.R. 1, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi

Central
DELHI
110002
India 
Phone  9811230029  
Fax    
Email  gargmridula7@gmail.com  
 
Source of Monetary or Material Support  
Institute of Study - GB Pant Insititute of Postgraduate Medical Education and Research, New Delhi  
 
Primary Sponsor  
Name  Not applicable  
Address  Not applicable  
Type of Sponsor  Other [Nil] 
 
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 
Mridula Garg  GB Pant Insititute of Postgraduate Medical Education and Research  GB Pant Institute of Postgraduate Medical Education and Research 1, Jawaharlal Nehru Marg, 64 Khamba, Raj Ghat, New Delhi, Delhi 110002
Central
DELHI 		 9811230029

gargmridula7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College and associated hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G437||Chronic migraine without aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard of care alone  The control group would be provided with standard of care for chronic migraine as per latest guidelines only.  
Intervention  Therapeutic patient education with standard of care   Imparted as lectre- type sessions to patients in intervention group at regular intervals. This will be accompanied by standard of care treatment for chronic migraine as per latest guidelines. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Any patient fulfilling diagnostic criteria for chronic migraine with or without aura as laid by ICHD-3 (International Classification of Headache Disorders) 
 
ExclusionCriteria 
Details  All patients with a clinical phenotype of chronic migraine but on further investigation, found to have a secondary cause for their headache  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Migraine Specific Quality of Life Score from baseline per 4 weeks for weeks 9-12 weeks  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in mean Headache Impact Test-6 from baseline per 4 weeks for weeks 9-12 weeks  12 weeks 
Change in mean Migraine Disability Assessment from baseline per 4 weeks for weeks 9-12 weeks  12 weeks 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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   N/A 
Date of First Enrollment (India)   01/07/2022 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study is a randomised control trial to objectively measure the efficacy of therapeutic patient education with standard of care compared with standard of care alone for the management of chronic migraine.
Chronic migraine is a prevalent, debilitating condition that affects patients lifelong and hampers their everyday life and productivity. While drug treatment is available, it comes with its own caveat of Medicine Overuse Headache (MOH), and other side effects. There is burning need for behavioral interventions such as education to make lifestyle modifications that lead towards better patient outcome. This is key to health promotion. 
 
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