A Study To Assess The Effect Of Pyridoxine Supplementation In Preventing Migraine Attacks

Phase 4

Not yet recruiting

Conditions: Migraine,

Registration Number: CTRI/2018/07/014731

Lead Sponsor: Dr N Caroline devakirubai

Brief Summary: Migraine is a debilitating , 2ndcommon cause of chronic headache affecting 15% women and 6% men annually. Migraine with aura (MA) and migraine without aura are 2subtypes. 25 % patients experience aura preceding the onset of pain. Aura is a transient disturbance in visual,sensory, language, or motor function. Pathophysiology of migraine includesgenetic, environmental triggers, cerebral ischemia followed by stimulationof trigeminovascular system which inturn results in the symptoms. Acute attack of mild migraine can bemanaged by oral agents, but the averageefficacy rate is only 50 â€“ 70%. Patients with increased frequency of migraine attacks or unresponsiveor poorly responsive to currently prescribed standard treatment, are started on long term prophylaxis and often expensive with side effects.Pyridoxine is a vitamin ofB complex group involved in metabolism reactions of the nervous system. Previous studieswere done with combination of B complex vitamins, or Pyridoxine as montherapy for a period of 12 weeks, found to have beneficial effectson severity and frequency of migraine attacks, but the participants were notfollowed up after stopping pyridoxine supplementation .Hence this study is planned to supplement pyridoxine in patients uncontrolled with standardprophylaxis to assess the effect of pyridoxine supplementation as anadjuvant for reduction of symptomsfrequency for a period of 6 months and recurrence during the follow up period for 3 months after stoppingpyridoxine, while standard therapy is continued.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Patients diagnosed as chronic migraine and on regular prophylaxis 6months or more Patients willing to give a written informed consent.

Exclusion Criteria

Patients with headache other than migraine Patients with peripheral neuropathy or photosensitivity Patients with major systemic illness Patients taking vitamin supplements.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reduction of MIDAS score	9 Months

Secondary Outcome Measures

Name	Time	Method
The tolerability of the study drug will be assessed in migraine patients clinically	tolerability of the intervention drug pyridoxine for the period of 6 months and 3 months follow up

Trial Locations

Locations (1): Chengalpattu Medical College
🇮🇳
Kancheepuram, TAMIL NADU, India
Chengalpattu Medical College
🇮🇳Kancheepuram, TAMIL NADU, India
Dr N Caroline devakirubai
Principal investigator
9442151228
drcarol06@gmail.com