| CTRI Number |
CTRI/2026/02/102770 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know the effect of Vishnu taila Nasya in Migraine |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Vishnu Taila Nasya in the Management of Ardhavabhedaka wsr to Migraine |
| 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 Rakshitha |
| Designation |
Postgraduate |
| Affiliation |
KVG Ayurveda Medical College |
| Address |
Department of Panchakarma
Room no 1
KVG Ayurveda Medical College and Hospital
Ambate Adka Kurunjibagh Sullia- 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
7026364321 |
| Fax |
|
| Email |
rakshitha151999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanath Kumar D G |
| Designation |
Professor and HOD |
| Affiliation |
KVG Ayurveda Medical College |
| Address |
Dr Sanath Kumar D G
Professor and HOD
Department of Panchakarma
Room no 1
Panchakarma OPD
KVG Ayurveda Medical College and Hospital
Ambate Adka Kurunjibagh Sullia-574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448152543 |
| Fax |
|
| Email |
sanathdg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanath Kumar D G |
| Designation |
Professor and HOD |
| Affiliation |
KVG Ayurveda Medical College |
| Address |
Dr Sanath Kumar D G
Professor and HOD
Department of Panchakarma
Room no 1
Panchakarma OPD
KVG Ayurveda Medical College and Hospital
Ambate Adka Kurunjibagh Sullia-574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448152543 |
| Fax |
|
| Email |
sanathdg@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Ayurveda Medical College and Hospital Ambate Adka Kurunjibagh Sullia Dakshina Kannada Karnataka India Pincode 574327 |
|
|
Primary Sponsor
|
| Name |
Dr Rakshitha |
| Address |
KVG Ayurveda Medical College
Ambate Adka Kurunjibagh Sullia- 574327 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rakshitha |
KVG Ayurveda Medical College and Hospital |
Room no.1 Panchakarma OPD KVG ayurveda medical college and hospital Ambate adka Kurunjibagh Sullia Dakshins kannada-574327
Sullia Dakshina Kannada
Dakshina Kannada
KARNATAKA |
7026364321
rakshitha151999@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Ayurveda Medical College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam | (Procedure Reference: Charaka samhitha siddhi sthana 9th chapter , Procedure details: Poorvakarma- Snehana & Swedana
Pradhana karma - Nasal instillation of 8 bindu vishnu taila into each nostril alternatively
Pashchat karma - Mardhana & spitting of medicine followed by Kavala & Dhoomapana)
(1) Medicine Name: Vishnu Taila, Reference: Bhaishajya Rathnavali, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with classical lakshanas of Ardhavabhedaka and symptoms of migraines
2. Patients of both genders who are Nasya Yogya according to ayurvedic classics
3. Patients in between 18 years and 70 years of age |
|
| ExclusionCriteria |
| Details |
1.Patients who are Nasya Ayogya according to Ayurvedic classics
2.Patients below 18 years and above 70 years of age
3.Patients suffering from any other forms of headaches apart from Ardhavabhedaka
4. Headache secondary to Meningitis, Tumour, Encephalitis, Spondylosis, or any other intracranial lesions and refractive errors |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Vishnu taila nasya in Ardhavabhedaka(Migraine)
To study Nasya karma in detail
To study Ardhavabhedaka in detail |
Nasya - 7 days
Follow up - 14 days
Total duration- 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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 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
|
Ayurveda is a holistic science of life and also called as ‘Mother of all healings’. Ardhavabhedaka is one among the Jatru Urdwagata roga, elaborately described under eleven types of shirorogas mentioned by Acharya Sushrutha. Lakshanas include severe pain in one half of shirts ie, Manya, Bhru, Karna, Akshi, Shankha and Lalaata. It can be correlated to Migraine due to its cardinal features of half sided headache. In Contemporary science, treatment of migraine involves analgesics, NSAIDs, neurotoxins, antipsychotics etc which relieve pain and its other symptoms resulting in hepatotoxicity, cardiotoxicity and nephrotoxicity on prolonged use. Panchakarma are a set of treatment procedures in ayurveda in which utklishta doshas are expelled out of the body through the nearest route. It is a unique approach of Ayurveda, which has a role in promotive, preventive and curative aspects. Vishnu taila which has Tridosha shamaka property is mentioned in Bhaishajya Ratnavali under Vatavyadhi Chikitsa adhikaara with a specific indication in Ardhavabhedaka. Nasya karma is one among the Panchakarma procedures especially mentioned for urdwajatrugata vikaras in which medicines or medicated oils are administered through nostrils (Nasa) which is considered as gateway to the shiras. So the present study is designed to evaluate the efficacy of Vishnu Taila nasya in the management of Ardhavabhedaka
|