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CTRI Number  CTRI/2025/07/090976 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 19/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of Migraine headache through Ayurveda  
Scientific Title of Study   AN OPEN LABEL SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFECT OF GAJAPIPPALI AGNIKARMA WITH RASNADASHAMOOLA KASHAYA GHANAVATI ABHYANTARA PRAYOGA IN THE MANAGEMENT OF ARDHAVABHEDAKA VIS-A-VIS 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 Ramyashree H S  
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College and Hospital, Mysuru 
Address  Department of PG Studies in Shalakya Tantra, JSS Ayurveda Medical College and Hospital, Lalithadripura road, Alanahalli, Mysuru - 570028 Karnataka Room No. 4
491, 4th cross, 2nd main, Vinayaka Layout, KR Nagar, Mysuru - 571602
Mysore
KARNATAKA
570028
India 
Phone  9740529360  
Fax    
Email  ramyagowdarhs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gavimath Shivanand  
Designation  Professor 
Affiliation  JSS Ayurveda Medical College and Hospital, Mysuru 
Address  Head of the Department, Department of PG Studies in Shalakya Tantra, JSS Ayurveda Medical College and Hospital, Lalithadripura road, Alanahalli, Mysuru - 570028 Karnataka Room No. 4
Head of the Department, Department of PG Studies in Shalakya Tantra, JSS Ayurveda Medical College and Hospital, Lalithadripura road, Alanahalli, Mysuru - 570028 Karnataka Room No. 4
Mysore
KARNATAKA
570028
India 
Phone  9448211075  
Fax    
Email  shiva.shalakya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramyashree H S  
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College and Hospital, Mysuru 
Address  Department of PG Studies in Shalakya Tantra, JSS Ayurveda Medical College and Hospital, Lalithadripura road, Alanahalli, Mysuru - 570028 Karnataka Room No. 4
491, 4th cross, 2nd main, Vinayaka Layout, KR Nagar, Mysuru - 571602
Mysore
KARNATAKA
570028
India 
Phone  9740529360  
Fax    
Email  ramyagowdarhs@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital 41 Lalitadripura Road Alanahalli Mysuru Karnataka India 570028 
 
Primary Sponsor  
Name  Dr Ramyashree H S 
Address  Post Graduate Scholar Department of PG Studies in Shalakya Tantra JSS Ayurveda Medical College and Hospital Lalitadripura Road Alanahalli Mysuru Karnataka India 570028 
Type of Sponsor  Other [] 
 
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 Ramyashree H S   JSS Ayurveda Medical College and Hospital   Department of PG Studies in Shalakya Tantra JSS Ayurveda Medical College and Hospital Lalitadripura Road Alanahalli
Mysore
KARNATAKA 		 09740529360

ramyagowdarhs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, JSS Ayurveda Medical College, Mysuru   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Charaka Samhita, Ashtanga Hridaya, Procedure details: Purvakarma- Patient is asked to lie down in lateral position and clean the Shankha pradesha with Triphala Kwatha Pradhana karma - Heat the Panchadhatu Shalaka till red hot and brand a mark on Shankha pradesha for 0.3 seconds Paschat Karma- Application of mixture of Madhu and Ghrita)
(1) Medicine Name: Pathyadi kwatha, Reference: Sharangdhar Samhita , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 22 Days
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta Samhita Sutrasthana, Charaka Samhita , Procedure details: Purva karma- Patient will be made to lie down on Lateral Position and Shankha Pradesha (Temporal region of face) will be thoroughly cleaned with Triphala Kwatha. Pradhana karma - Agnikarma with Gajapippali for 0.3-0.5 seconds 4 times at the interval of 7 days 1st, 8th, 15th and 22nd day Pashchat karma - Lepa of Madhu and Ghrita on the site.)
(1) Medicine Name: Rasnadashamoola Kashaya Ghanavati, Reference: Vangasena Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 22 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects presenting with signs and symptoms of Ardhavabhedaka irrespective of gender, race, religion and occupation.
Migraine without Aura
Subjects aged between 18 years to 70 years.
Subjects who fit for Agnikarma.

 
 
ExclusionCriteria 
Details  Migraine with aura and other type of Headache
Referred pain in one half of the head due to disorders of Eye, Ear, Nose, Throat, Teeth etc.
Subjects with HTN and other systemic illness.
Subjects on any other medications which is interfering with trial treatment.
Subjects under Ante-natal care and lactating women. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Reduction in Serum Pituitary Adenylate Cyclase Activating Polypeptide - 38 (PACAP-38)  22 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Bheda, Toda, Bhrama
Reduction in Ardha Shirashoola
Reduction in Nausea, Vomiting, Photophobia, Phonophobia
Reduction in Headache impact test-6 score 		 22 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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/08/2025 
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="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Ardhavabhedaka is characterized by Bheda (splitting type of pain), Toda (pricking type of pain), Bhrama (giddiness) and Shirashoola (headache) on half part of the cranium. It occurs once in 10 or 15 days or suddenly. Ardhavabhedaka can be correlated to migraine. Migraine affects more than one billion individuals each year across the world, and is one of the most common neurological disorders, with a high prevalence and morbidity, especially among young adults and females. Migraine headache reoccurs frequently, which is more severe and has unilateral involvement. The pain has pulsating quality, is aggravated by routine physical activities and is associated with nausea, photophobia and phonophobia. Pituitary adenylate cyclase-activating polypeptide -38 (PACAP) is one of the important mediators in the pathogenesis of Migraine. PACAP-38 causes dilatation of extracerebral vessels and Migraine attacks. It selectively activates the PAC1 receptor, which is a signaling pathway implicated in Migraine pain. Ardhavabhedaka is a Vata Dosha Pradhana condition and pain cannot occur without involvement of Vata. So Agnikarma pacify vata by virtue of its Ushna and Tikshna Guna. Pippali and Panchadhatu shalaka are the dahanopakaranas mentioned by Acharya Sushruta. Rasna dashamoola Kashaya and Pathyadi Kashaya are indicated in Ardhavabhedaka.  
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