FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/098809 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [prospective randomized controlled]  
Study Design  Other 
Public Title of Study   To see the effect of ayurvedic medicated ghee nasal drops in headache  
Scientific Title of Study   An open label two armed prospective randomized controlled phase II clinical study to evaluate the efficacy of Brahmi ghrut nasya in the management of Migraine Ardhavbhedak 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Adeeba asad 
Designation  2nd Year BAMS(UG) student 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 
Address  OPD no 11 Balaroga OPD

Nashik
MAHARASHTRA
422003
India 
Phone  9696191148  
Fax    
Email  asadadeeba77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Adeeba asad 
Designation  2nd Year BAMS(UG) student 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 
Address  OPD no 11 Balaroga OPD
ganeshwadi panchavati nashik 422002
Nashik
MAHARASHTRA
422003
India 
Phone  9696191148  
Fax    
Email  asadadeeba77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Adeeba asad 
Designation  2nd Year BAMS(UG) student 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 
Address  OPD no 11 Balaroga OPD
ganeshwadi panchavati nashik 422002
Nashik
MAHARASHTRA
422003
India 
Phone  9696191148  
Fax    
Email  asadadeeba77@gmail.com  
 
Source of Monetary or Material Support  
The Registrar Maharashtra University of Health Sciences Vani road Nashik 422004 Maharashtra India 
 
Primary Sponsor  
Name  Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 
Address  Ayurved Seva Sangh Ayurved mahavidyalaya Ganeshwadi panchavati Nashik 422003 Maharashtra India 
Type of Sponsor  Other [Maharashtra Govt aided Institution] 
 
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 Adeeba Asad  Arogyashala Hospital  OPD no 11 Balaroga OPD
Nashik
MAHARASHTRA 
9696191148

asadadeeba77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Ayurved Seva Sangh Ayurved mahavidyalaya, Nashik   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G508||Other disorders of trigeminal nerve. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Brahmi ghrita, Reference: Charak samhita , Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Ibuprofen 400mgIbuprofen 400 mg as per requirement for 30 days with water
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Adult individuals aged 18 50 years
Diagnosed with Migraine Ardhavbhedhak according to ICHD3 criteria migraine is characterized by recurrent headache attacks lasting 4 72 hours with at least two of the following unilateral location pulsating quality moderate or severe pain, and aggravation by or causing avoidance of routine physical activity
At least 2 4 episodes of migraine per month for the last 3 months
Able to provide written informed consent
 
 
ExclusionCriteria 
Details  Pregnant or lactating women
History of any significant neurological disorders other than migraine
Any other chronic medical conditions eg cardiovascular renal hepatic disease
Ongoing use of other migraine-specific treatments or herbal therapies during the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Monthly Migraine Days MMD baseline Day 30

Difference in number of migraine days in 28 day run in baseline vs days 1 30 end of treatment
 
30 days 
 
Secondary Outcome  
Outcome  TimePoints 
50% Responder Rate at Day 30 proportion with 50% reduction in MMD vs baseline


Change in Headache Intensity — mean change in NRS (0–10) for migraine attacksnbaseline Day 30


Rescue Medication Use change in number of acute medication doses taken in 30 days vs baseline month
 
30 days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2 
Date of First Enrollment (India)   26/12/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 migraine is a type of headache that is often intense and can cause severe pain usually on one side of the head In addition to the pain migraines can come with other symptoms like nausea vomiting and sensitivity to light and sound They can last anywhere from a few hours to several days and for some people they can be debilitating Migraines are believed to be caused by a combination of genetic and environmental factors They may be triggered by certain foods stress changes in sleep patterns hormonal fluctuations or weather changes   Ardhavbhedak is the Ayurvedic term for what is commonly known as migraine in modern medicine  The word Ardhavbhedak comes from two Sanskrit words Ardha meaning half and  Bhedak meaning to pierce or penetrate This refers to the characteristic of the pain being one-sided usually affecting one half of the head and severe like a sharp piercing pain often seen in migraines In Ayurveda Ardhavbhedak is typically attributed to an imbalance of the Vata and Pitta doshas though it can also involve Kapha imbalances in some case As per classical texts Brahmi is described as Medhya Rasayana helps to reduce stress and anxiety  hence bramhi ghrita is often prescribed for migraine  we will attempt to study the efficacy of Nasya process using bramhi ghrita in patients suffering from migraines 

 
Close