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CTRI Number  CTRI/2025/03/082800 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nutritional Education]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Can a Nutrition-Based Education Program Reduce Headache Frequency and Disability in Migraine Patients? A Study at AIIMS, New Delhi. 
Scientific Title of Study   A Randomised Controlled Trial to assess the effectiveness of Optimised Nutritional Education on Headache Frequency and Disability among Migraine patients attending the Neurosciences OPD at AIIMS, New Delhi. 
Trial Acronym  N/A 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tamanna Kumari 
Designation  M.Sc. Nursing Student 
Affiliation  All India Institute of Medical Sciences 
Address  Porta Cabin - 2, College of Nursing, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029
College of Nursing, All India Institute of Medical Sciences, New Delhi 110029
South
DELHI
110029
India 
Phone  8447664642  
Fax    
Email  tamanna61210@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aditi Prashant Sinha 
Designation  Associate Professor 
Affiliation  All India Institute Of Medical Sciences, New Delhi 
Address  2nd floor, College of Nursing, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029

South
DELHI
110029
India 
Phone  9810784806  
Fax    
Email  aaditiprashant@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aditi Prashant Sinha 
Designation  Associate Professor 
Affiliation  All India Institute Of Medical Sciences, New Delhi 
Address  2nd floor, College of Nursing, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029

South
DELHI
110029
India 
Phone  9810784806  
Fax    
Email  aaditiprashant@gmail.com  
 
Source of Monetary or Material Support  
College Of Nursing All India Institute Of Medical Sciences New Delhi 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences, New Delhi 
Address  Porta cabin -2, College of Nursing, All India Institute Of Medical Sciences New Delhi- 110029 
Type of Sponsor  Research institution and hospital 
 
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 
Tamanna Kumari  All India Institute of Medical Sciences  Room No. 7, Ground Floor, Neurosciences OPD, CNC, AIIMS New Delhi
South
DELHI 		 8447664642

tamanna61210@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G439||Migraine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Optimised Nutritional Education  Structured Optimised Nutritional Education via written dietary plan and strategies incorporating migraine friendly foods with identification of dietary triggers. 
Comparator Agent  Standardised care   only standardised care will be given along with some knowledge of migraine and related triggers. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adults with more than 18 years diagnosed with episodic migraine.
2. Participants having 4 migraine attacks in last 1 month.
3. Willingness to adhere to the dietary education intervention.
4. Those who understand Hindi or English. 
 
ExclusionCriteria 
Details  1. Patient with chronic headache disorder.
2. Individual currently on a restrictive diet.
3. Presence of other Neurological Disorders or any Psychiatric condition.
4. Patient with significant co-morbid conditions (eg., Cancer, Diabetes, Chronic Renal insufficiency). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of patient with 30% reduction in headache frequency by Headache Diary.
2. Proportion of patient with 30% reduction in disability scores measured by MIDAS, HIT-6. 		 1. Migraine frequency
Baseline at day 1
Follow up at day 30
Follow up at day 60
Follow up at day 90

2. Migraine Disability
Baseline at day 1
Followup at day 90
 
 
Secondary Outcome  
Outcome  TimePoints 
3. To assess the adherence of optimised nutritional education among migraine patients at Neuroscience OPD, AIIMS New Delhi.

4. To assess the barriers in adherence to optimised nutritional education among migraine patients at Neuroscience OPD, AIIMS New Delhi. 		 Adherence for optimised nutritional education
Baseline at day 1
Day 90

Telephonic followup
Day 15
Day 45
Day 75

Barriers in adherence
Day 90 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   N/A 
Date of First Enrollment (India)   01/08/2025 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   A Randomised Controlled Trial to assess the effectiveness of Optimised Nutritional Education on Headache Frequency and Disability among Migraine patients attending the Neurosciences OPD at AIIMS, New Delhi
Headache disorders are among the most common disorders of the nervous system, ranking third (after stroke and dementia) in contributing to the overall neurological disease burden, as measured by age-standardized disability-adjusted life years (DALYs) in 2019.Migraine is a complex neurological illness with a genetic component, characterized by episodes of moderate-to-severe headaches, typically unilateral, and often accompanied by nausea, photophobia, and phonophobia.
According to the Global Burden of Disease study, migraines account for 4.9% of all years lived with disability, To evaluate the effectiveness of optimised nutritional education on headache frequency and disability among migraine patients attending the Neuroscience Outpatient Department(OPD) at AIIMS, New Delhi. Research approach : Quantitative approach, Research design : Randomized Controlled Trial (RCT) Trial Design: A parallel-group randomized controlled trial with a 1:1 allocation ratio. The sample size is calculated to detect a 30% reduction in primary outcomes (headache frequency and disability) with 90% power and a 5% significance level. Intervention Group: 
Structured Optimised Nutritional Education including:-Written dietary plans, Strategies for incorporating migraine-friendly foods., Identification of dietary triggers.
There will be significant difference in headache frequency after optimised nutritional education in intervention group in comparison with control group at the 0.05 level of significance.
 
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