| CTRI Number |
CTRI/2026/03/105566 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effectiveness of Marma therapy and Nasya Therapy in the management of Migraine. |
|
Scientific Title of Study
|
Comparative Clinico-Anatomical Study To Evaluate The Efficacy Of Marma Chikitsa And Shadbindu Taila Nasya In The Management Of Ardhavbhedaka |
| 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 Nirav Baraiya |
| Designation |
Pg Scholar |
| Affiliation |
MADAN MOHAN MALVIYA GOVT AYURVED COLLEGE UDAIPUR RAJASTHAN |
| Address |
Pg Department Of Rachana Sharir Madan Mohan Malviya Government
Ayurved College Udaipur Rajasthan 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9377878740 |
| Fax |
|
| Email |
nirav.baraiya1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jitendra Kumar Sharma |
| Designation |
Professor |
| Affiliation |
MADAN MOHAN MALVIYA GOVT AYURVED COLLEGE UDAIPUR RAJASTHAN |
| Address |
Pg Department Of Rachana Sharir Madan Mohan Malviya Government
Ayurved College Udaipur Rajasthan 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9784988488 |
| Fax |
|
| Email |
jk2011sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Jitendra Kumar Sharma |
| Designation |
Professor |
| Affiliation |
MADAN MOHAN MALVIYA GOVT AYURVED COLLEGE UDAIPUR RAJASTHAN |
| Address |
Pg Department Of Rachana Sharir Madan Mohan Malviya Government
Ayurved College Udaipur Rajasthan 313001
RAJASTHAN
313001
India |
| Phone |
9784988488 |
| Fax |
|
| Email |
jk2011sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College udaipur |
| Address |
Pg Department Of Rachana Sharir Madan Mohan Malviya Government
Ayurved College Udaipur Rajasthan 313001
|
| Type of Sponsor |
Government medical college |
|
|
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 Nirav Baraiya |
Madan Mohan Malviya Government Ayurved College Udaipur |
Pg Department Of Rachana Sharir Madan Mohan Malviya Government
Ayurved College Udaipur Rajasthan 313001
Udaipur
RAJASTHAN |
9377878740
nirav.baraiya1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MMM Govt Ayurved College Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Bhaishajya Ratnavali, Shiroroadhikar, 65/81-83, Procedure details: Three drops of lukewarm Shadbindu Taila will be instilled into each nostril(Total 6 drop),
daily morning on an empty stomach after evacuating bowels and bladder. The patient will
be asked to lie down with the head tilted back, remain in supine position for a few minutes,
and then spit out any oil that drains into the throat.)
(1) Medicine Name: Shadbindu Taila, Reference: Bhaishajya Ratnavali, Shiroroadhikar, 65/81-83, Route: Nasal, Dosage Form: Taila, Dose: 3(drops), Frequency: od, Duration: 2 Months | | 2 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: Angirasi Chikitsa, Procedure details: Using your thumb or fingertips, apply firm but painless pressure to each point. Perform a rhythmic press-and-release motion 15 times per point, practicing this routine once daily.)
|
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Ardhavbhedaka (migraine) as per classical Ayurvedic texts and fulfilling the
ICHD-3 criteria for migraine without aura.
2. Age between 14 and 60 years.
3. Both male and female patients.
4. Patients willing to give informed consent and adhere to the study protocol.
5. Patients with a history of migraine for at least 6 months.
6. Patients experiencing at least 2 migraine attacks per month. |
|
| ExclusionCriteria |
| Details |
1. Patients with secondary headaches (e.g., due to brain tumor, sinusitis, glaucoma, etc.).
2. Patients with other severe systemic illnesses Like - uncontrolled hypertension, diabetes mellitus, renal
failure, cardiac disorders.
3. Pregnant or lactating women.
4. Patients with psychiatric disorders.
5. Patients with a history of head injury or intracranial surgery.
6. Patients on prophylactic migraine medication for less than 3 months or unwilling to stop/adjust their
current medication under medical supervision (if deemed necessary and safe).
7. Patients with known hypersensitivity to Shadbindu Taila ingredients.
8. Patients with nasal polyps, severe deviated nasal septum, or acute sinusitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome Name: Change in Headache Intensity and Functional Disability.
Method of Measurement:
1. Visual Analogue Scale (VAS):
To assess the subjective intensity of pain on a scale of 0 to 10.
2. Migraine Disability Assessment (MIDAS) Score:
To evaluate the impact of headache on the patients daily life and functional productivity. |
Baseline (Day 0), Mid-treatment (Day 15), Post-treatment (Day 30), and Follow-up (Day 45 & 60). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2026 |
| 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="10"
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
|
Ardhavbhedaka Is A Debilitating Neurological Condition Correlated With Migraine In Modern Medicine Characterized By Intense Throbbing Pain Affecting One Side Of The Head Along With Symptoms Like Nausea And Photophobia.
This Research Is A Randomized Controlled Clinical Trial Designed As A Comparative Clinico Anatomical Study To Evaluate Two Traditional Ayurvedic Modalities In Managing This Condition. The Study Aims To Compare The Efficacy Of Marma Chikitsa Specifically Gentle Pressure On Selected Vital Points And Nasya Therapy Using Shadbindu Taila. The Selected Marma Points For Stimulation Include Shankha,Sthapani, Apanga, Avarta, Vidhura And Krikatika Which Hold Significant Anatomical And Physiological Importance In The Head And Neck Region.
Sixty Patients Will Be Recruited And Divided Into Two Groups Of Thirty Participants Each. Group A Will Receive Marma Chikitsa Once Daily For Two Months While Group B Will Undergo Nasya Therapy With Three Drops Of Shadbindu Taila In Each Nostril For The Same Duration. The Study Includes An In Depth Applied Anatomical Evaluation Of These Points Correlating Them With Modern Neurovascular Structures. Therapeutic Outcomes Will Be Assessed Based On Reduction In The Frequency Intensity And Duration Of Headache Attacks. Objective Improvement Will Be Measured Using The Midas Score To Evaluate Changes In Disability And Quality Of Life. This Research Will Provide Scientific Validation For Marma Chikitsa As A Non Invasive Intervention For Migraine Management. |