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CTRI Number  CTRI/2022/08/044685 [Registered on: 05/08/2022] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Study of the role of hyperimmunity in half-headache 
Scientific Title of Study   Investigation of Autoimmunity in migraine patients: A perspective case-controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Murugesan Arumugam MPharm PhD 
Designation  Assistant Professor in Pharmacology  
Affiliation  Sri Ramachandra Faculty of Pharmacy Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Faculty of Pharmacy, Department of Pharmacology, Sri Ramachandra Institute of Higher Education and Research, Porur Chennai TAMIL NADU 600116 India

Chennai
TAMIL NADU
600116
India 
Phone  8870151588   
Fax    
Email  murugesan.a@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Murugesan Arumugam MPharm PhD 
Designation  Assistant Professor in Pharmacology  
Affiliation  Sri Ramachandra Faculty of Pharmacy Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Faculty of Pharmacy, Department of Pharmacology, Sri Ramachandra Institute of Higher Education and Research, Porur Chennai TAMIL NADU 600116 India

Chennai
TAMIL NADU
600116
India 
Phone  8870151588   
Fax    
Email  murugesan.a@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Pavithra M 
Designation  Masters in Pharmacology 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  Sri Ramachandra Faculty of Pharmacy, Department of Pharmacology, Sri Ramachandra Institute of Higher Education and Research, Porur Chennai 600116 India

Chennai
TAMIL NADU
600116
India 
Phone  8610377592  
Fax    
Email  pavimurugan2003@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Hospital, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai 600116, Tamil Nadu, India  
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research DU 
Address  No.1 Ramachandra nagar Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116  
Type of Sponsor  Other [Funding Society] 
 
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 Murugesan Arumugam  Sri Ramachandra hospital, Department of Neurology   No.1 Ramachandra nagar Sri Ramachandra Institute of Higher Education and Research Porur Chennai 600116
Chennai
TAMIL NADU 
8870151588

murugesan.a@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, SRIHER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G894||Chronic pain syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Migraine with aura and without aura patients
2. Patients between 18 to 60 years old
3. Patients affected by COVID-19
4. Patients with other autoimmune disorder
 
 
ExclusionCriteria 
Details  1. Migraine patients with other comorbid diseases
2. Patients who had not taken any medications for migraine
3. Pregnant and lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will compare the levels of autoantibodies in migraine patients with those of healthy volunteers in order to determine whether immunological malfunction may be the cause of migraine attacks.   Investigation of 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
This study will detect the autoantibody levels in migraine patients and will help in better understanding of migraine as an autoimmune disorder  Investigation of 1 year 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Migraine is a neurological disorder characterized by repeated, moderate to severe headaches. Usually, one side of the brain is affected by throbbing episodes that last between a few hours to three days. Though the exact pathophysiology of migraine is still unclear, several initial treatments such as monoclonal antibodies, NSAIDs, Triptans etc., are currently available to treat migraine. Unfortunately, none of these treatments provide sufficiently tangible therapeutic advantages for migraine patients. On the other hand, our recent analysis found that CD4+CD25+ regulatory T cells (Treg) are reduced in migraine patients as compared with healthy volunteers. Tregs are the subset of CD4+ T cells that play a role in regulating or suppressing other cells in the immune system.

In support of this, during the impact of COVID-19, people with pre-existing migraine or those who had never experienced a headache in their lifetime were affected. Headache is a common symptom of SARS-CoV2 (active COVID-19), and people develop a persistent headache after having COVID-19, which is said to be a post-COVID headache, even though it continues after having a negative result of the infection. People who have been exposed to COVID-19 may experience post-COVID headaches, but this effect is worsening in migraine patients. Accordingly, covid vaccination also aggravates the migraine attacks in patients. After the vaccination, pre-existing migraine patients develop a more severe, long-lasting, and hard-wearing migraine attacks compared to normal patients. Overall, it suggests that an immunological imbalance in the body plays a major role in migraine’s progression.

Therefore, in this observational study, an autoantibody test will be conducted on the migraine patient’s blood samples which may confirm that migraine could be an autoimmune disorder.

 
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