| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G508||Other disorders of trigeminal nerve. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Ibuprofen 400mg | Ibuprofen 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 |