| CTRI Number |
CTRI/2024/09/074182 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying B cell Activating Factor (BAFF) and Proliferation-Inducing Ligand (APRIL) Levels Before, During, and After Migraine Pain to Explore Possible Autoimmune Links |
|
Scientific Title of Study
|
Evaluating The Role of B cell activating factor (BAFF) and proliferation-inducing ligand (APRIL) Levels in Migraine Phases to determine autoimmune Characteristics |
| Trial Acronym |
Mig_BAFF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Murugesan Arumugam |
| Designation |
Assistant Professor in Pharmacology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
Pharmacology Lab, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
8870151588 |
| Fax |
|
| Email |
murugesan.a@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Murugesan Arumugam |
| Designation |
Assistant Professor in Pharmacology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
Pharmacology Lab, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
8870151588 |
| Fax |
|
| Email |
murugesan.a@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Smitha S |
| Designation |
Pharm D Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Pharmacology Lab, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur
Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9344990059 |
| Fax |
|
| Email |
nsmithi449@gmail.com |
|
|
Source of Monetary or Material Support
|
| NO 360, (NP), Sidco Industrial Estate, Ambattur, Chennai, Tamil Nadu, India, 600098 |
| Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu, India, 600116 |
|
|
Primary Sponsor
|
| Name |
AVICENCE Research Private Limited |
| Address |
NO 360, (NP), Sidco Industrial Estate, Ambattur, Chennai, Tamil Nadu, India, 600098 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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, SRIHER |
Department of Neurology No.1, Ramachandra nagar, Sri Ramachandra nagar, 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: G439||Migraine, unspecified, |
|
|
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 |
Both |
| Details |
Migraine patients with and without aura
Patients who are aged above 18 years |
|
| ExclusionCriteria |
| Details |
1.Patients with additional comorbidity conditions were not allowed to participate.
2.Patients who have recently taken any immunosuppressants
3.Pregnant women were excluded
4.Patients with previous head injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantification of BAFF and APRIL levels in different phases of migraine |
BAFF and APRIL levels will be quantified at specific time points during the pre-ictal, ictal, and post-ictal phases of a migraine. However, the exact timing of these phases may vary based on the development of migraine pain in each patient, so precise time points cannot be assured. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/09/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Migraine is a chronic neurological disorder characterized by a throbbing headache, typically on one side of the head, along with symptoms such as nausea, sensitivity to light, and disturbances in autonomic, mental, sensory, and motor functions. There are two subtypes of migraine: migraine with aura and migraine without aura. According to the Global Burden of Disease Study (2015), migraine is the most prevalent neurological condition and the third leading cause of disability worldwide, even though its exact cause is not fully understood. Due to our incomplete understanding of its underlying mechanisms, no specific treatment is available for migraine patients.
Previous research has indicated that levels of CD4+ and CD25+ regulatory T cells are lower in migraine patients compared to healthy volunteers. Furthermore, mutations in the Fox P3 gene were observed in migraine patients, which can lead to impairment in the regulation of Tregulatory cells and may be linked to the early onset of autoimmune dysfunction.
These findings suggest that migraine may be an autoimmune condition. Our current study aims to evaluate the levels of BAFF and APRIL in migraine patients (with and without aura) during the pre-ictal, ictal, and post-ictal phases. |