Health Condition 1: G437- Chronic migraine without aura
Conditions
Interventions
Intervention1: Vitamin B12: Tablet Methylcobalamin 1mg once daily orally for 12 weeks
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
Sri Ramachandra Institute of Higher Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of chronic migraine according to ICHD-3 criteria At least 3 months history of stable migraine pattern Serum vitamin B12 less than 200 pgpermL at screening Ability to maintain headache diary and attend follow-up visits Written informed consent
Exclusion criteria
Exclusion criteria: Other primary or secondary headache disorders (cluster headache, medication-overuse headache) B12 supplementation or multivitamin use containing more than 5 g B12 in the past 3 months Pregnancy or lactation Significant renal (eGFR less than 60 mLpermin) or hepatic dysfunction Active malignancy or autoimmune disease requiring immunosuppression History of pernicious anaemia or malabsorption syndromes Change in migraine prophylactic medications within 3 months prior to enrolment Known allergy to cobalamin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Monthly Migraine Days (MMD)Timepoint: Baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Responder rate proportion of participants achieving more than or equal to 50% reduction in MMD at Week 12. Change in mean headache intensity (average NRS score on headache days) from baseline to Week 12 Change in headache-related disability (MIDAS score) from baseline to Week 12 Change in number of severe headache days (NRS more tahn or equal to 7) from baseline to Week 12Timepoint: Baseline and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Najma Sherin M
SRMC RI, SRIHER
Outcome results
None listed