| 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
|
|
|
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
|
|
|
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. |