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CTRI Number  CTRI/2018/07/014731 [Registered on: 04/07/2018] Trial Registered Prospectively
Last Modified On: 18/01/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study To Assess The Effect Of Pyridoxine Supplementation In Preventing Migraine Attacks  
Scientific Title of Study   A Randomized Controlled Trial To Study The Effect Of Pyridoxine As Adjuvant In Prophylaxis Of Migraine. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N Caroline Devakirubai  
Designation  Post graduate  
Affiliation  Chengalpattu Medical College 
Address  Department of Pharmacology Chengalpattu Medical College Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9442151228  
Fax    
Email  drcarol06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Vijayarani  
Designation  Associate Professor and HOD 
Affiliation  Chengalpattu Medical College 
Address  Department of Pharmacology Chengalpattu Medical College Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9444728805  
Fax    
Email  vijayapaed@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr N Caroline Devakirubai  
Designation  Post graduate  
Affiliation  Chengalpattu Medical College 
Address  Department of Pharmacology Chengalpattu Medical College Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9442151228  
Fax    
Email  drcarol06@gmail.com  
 
Source of Monetary or Material Support  
Chengalpattu Medical College Chengalpattu kanchipuram district Tamil Nadu 603001 India 
 
Primary Sponsor  
Name  Dr N Caroline devakirubai 
Address  Department of Pharmacology Chengalpattu Medical College Chengalpattu  
Type of Sponsor  Other [Self] 
 
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 N Caroline devakirubai  Chengalpattu Medical College  Department Of Neurology
Kancheepuram
TAMIL NADU 
9442151228

drcarol06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Migraine, (1) ICD-10 Condition: G43||Migraine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  amitryptyline sodium valproate propranolol   standard therapy alone for migraine prophylaxis amitryptyline 12.5 to 75 mg once daily or sodium valproate 200 mg to 600 mg per day or propranolol 20 to 120 mg per day for a period of 9months(entire study period) 
Intervention  Pyridoxine  Pyridoxine 80mg once daily for a period of six months along with standard drugs used in prophylaxis of Migraine. Standard therapy alone will be continued for another 3 months during follow up after stopping pyridoxine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients diagnosed as chronic migraine and on regular prophylaxis 6months or more
Patients willing to give a written informed consent
 
 
ExclusionCriteria 
Details  Patients with headache other than migraine
Patients with peripheral neuropathy or photosensitivity
Patients with major systemic illness
Patients taking vitamin supplements
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduction of MIDAS score  9 Months 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/07/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1.Sadeghi O, Nasiri M, Maghsoudi Z, Pahlavani N, Rezaie M, AskariGh.Effects of pyridoxine supplementation on severity, frequency and duration of migraine attacks in migraine patients with aura: A double-blind randomized clinical trial study in Iran. Iran J Neurol 2015; 14(2): 74-80.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Migraine is a debilitating , 2nd common cause of chronic  headache   affecting 15% women and 6% men annually. Migraine with aura (MA) and migraine without aura are 2 subtypes. 25 % patients experience aura preceding the onset of pain. Aura  is a transient disturbance in visual, sensory, language, or motor function. Pathophysiology of migraine includes genetic, environmental triggers, cerebral ischemia followed by stimulation of  trigeminovascular system which in turn results in the symptoms. Acute attack of mild migraine can be managed by oral agents, but the  average efficacy rate is only 50 – 70%. Patients with increased  frequency of migraine attacks or unresponsive or poorly responsive to currently prescribed  standard treatment, are started on long term prophylaxis and often expensive with side effects.Pyridoxine is a vitamin of B complex group involved in metabolism reactions of the nervous system. Previous studies were done with combination of B complex vitamins, or  Pyridoxine  as montherapy for a period of 12 weeks, found to have beneficial effects on severity and frequency of migraine attacks, but the participants were not followed up after stopping pyridoxine supplementation . Hence this study is  planned to supplement  pyridoxine in patients uncontrolled with standard prophylaxis to assess the effect of pyridoxine supplementation as an adjuvant  for reduction of symptoms frequency for a period of 6 months and recurrence during the  follow up period for 3 months after stopping pyridoxine, while standard therapy is continued.

 
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