| CTRI Number |
CTRI/2026/04/107478 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic treatment for headache. |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF DASHMOOLA TAILA NASYA WITH VIDDHA KARMA AND APAMARGA TAILA NASYA WITH VIDDHAKARMA IN ARDHAVABHEDAKA W.S.R TO MIGRAINE |
| Trial Acronym |
NAVAM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suyash Dhaigude |
| Designation |
PG Scholar |
| Affiliation |
Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Bagalkot, Karnataka. |
| Address |
Department of Shalakyatantra, OPD no-2, Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Bagalkot, Karnataka.
Department of Shalakyatantra, OPD no-2,Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Bagalkot, Karnataka.
Bagalkot
KARNATAKA
587125
India |
| Phone |
9673528482 |
| Fax |
|
| Email |
suyashdhaigude@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Pujari |
| Designation |
Associate Professor |
| Affiliation |
Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Bagalkot, Karnataka. |
| Address |
Department of Shalakyatantra, OPD no-2, Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Bagalkot, Karnataka.
Department of Shalakyatantra, OPD no-2, Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Bagalkot, Karnataka.
Bagalkot
KARNATAKA
587125
India |
| Phone |
8951079943 |
| Fax |
|
| Email |
pujar9943@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Pujari |
| Designation |
Associate Professor |
| Affiliation |
Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Bagalkot, Karnataka. |
| Address |
Department of Shalakyatantra, OPD no-2, Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Bagalkot, Karnataka.
Department of Shalakyatantra, OPD no-2, Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Bagalkot, Karnataka.
Bagalkot
KARNATAKA
587125
India |
| Phone |
8951079943 |
| Fax |
|
| Email |
pujar9943@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, OPD no-2, Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Karnataka. |
|
|
Primary Sponsor
|
| Name |
Shri Vijay Mahantesh Ayurvedic Medical College Ilkal Karnataka |
| Address |
Department of Shalakyatantra, OPD no-2, Shri Vijay Mahantesh Ayurvedic Medical College, Ilkal, Karnataka. |
| Type of Sponsor |
Private 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 Suyash Dhaigude |
S.V.M Ayurvedic Medical College and PG Research centre |
OPD NO.2 shri vijayamahentesh ayurvedic medical college and PG Research centre, R.P kardi hospital Ilkal District-Bagalkot-587125, Karnataka
Bagalkot
KARNATAKA |
9673528482
suyashdhaigude@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Svmamc/ethical/2025 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G43C||Periodic headache syndromes in child or adult. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Viddhakarma | (Procedure Reference: Bhaishajya Ratnavali, Procedure details: Viddha Karma was performed under strict aseptic precautions as per classical Ayurvedic principles.
Purva Karma (Pre-procedure):
The patient was examined & selected Viddha points were identified & marked. The area was cleaned with antiseptic solution & the patient was made comfortable in a suitable position.
Pradhana Karma (Main procedure):
Sterile disposable needle was used to perform controlled pricking (Viddhana) at the selected points. The depth & number of pricks were maintained as per classical reference & patient tolerance until appearance of mild blood oozing (Rakta Srava).
Paschat Karma (Post-procedure):
The site was cleaned with sterile gauze & mild pressure was applied to control bleeding. No bandaging was required unless necessary. The patient was advised to avoid exertion & exposure to dust & cold immediately after the procedure.)
| | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Bhaishajya Ratnavali, Procedure details: Purva Karma (Pre-procedure):
The patient was made to lie in supine position. Gentle facial massage (Mukha Abhyanga) with suitable oil was performed followed by mild fomentation (Swedana) over face & forehead.
Pradhana Karma (Main procedure):
The patient’s head was slightly tilted back. Lukewarm medicated oil (Taila) was instilled into each nostril (as per prescribed dose) using a dropper, one nostril at a time, while the other nostril was closed. The patient was advised to inhale gently during administration.
Paschat Karma (Post-procedure):
The patient was asked to spit out the expelled secretions. Gentle massage over palms, soles, and shoulders was done. The patient was advised to avoid talking loudly, exposure to dust, cold, and intake of cold food immediately after the procedure.)
(1) Medicine Name: Dashmoola taila nasya, Reference: Bhaishajya Ratnavali, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days(2) Medicine Name: Apamarga taila nasya, Reference: Bhaishajya Ratnavali, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of both genders of different socio economic group will be selected irrespected of caste and religion. |
|
| ExclusionCriteria |
| Details |
Patients with any other systemic disorders Cerebral Haemorrhagic Conditions,hypertension, Major Vascular Diseases.
Pathological conditions occurring In Eye, Ear, Nose, Throat and Teeth.
Patients who are suffering from secondary headaches like Meningitis, Brain Tumour, Encephalitis, Cervical spondylitis and Glaucoma.
Pregnant and lactating women are excluded from the study.
Any other blood related disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nasya and Viddhakarma have an effective role in Viddhakarma |
first follow up 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient can do his/her work without any complaints |
first follow up 15 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2026 |
| 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="1"
Months="0"
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
|
This randomized comparative clinical study aims to evaluate the efficacy of Dashmoola Taila Nasya with Viddha Karma and Apamarga Taila Nasya with Viddha Karma in the management of Ardhavabhedaka, correlated with migraine. Ardhavabhedaka is a type of Shiroroga in Ayurveda, presenting with unilateral, severe, and episodic headache resembling migraine. Patients will be randomly divided into two groups to receive either of the interventions. The assessment will be based on changes in frequency, intensity, and duration of headache along with associated symptoms such as nausea and photophobia. The outcomes will be statistically analyzed to compare the effectiveness of both therapies. This study aims to generate clinical evidence for Ayurvedic treatment modalities in the management of migraine. |