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
|
|
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
|
|
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. |