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CTRI Number  CTRI/2026/01/100106 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   A Study on Pathyadi Kwatha Nasya and Pathyadi Kwatha Pana In The Management Of Ardhavbhedaka 
Scientific Title of Study   A Randomized Comparative Clinical Study On Pathyadi Kwatha Nasya And Pathyadi Kwatha Pana In The Management Of Ardhavbhedaka With Special Reference 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 Aditi Sharma 
Designation  M.D. Scholar 
Affiliation  Jammu Institute Of Ayurveda And Research 
Address  P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123

Jammu
JAMMU & KASHMIR
181123
India 
Phone  8899576374  
Fax    
Email  sakshiaditi4516@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Mahajan 
Designation  Professor 
Affiliation  Jammu Institute Of Ayurveda And Research 
Address  P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9419119123  
Fax    
Email  Dr.nitinmahajan1608@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Sharma 
Designation  M.D. Scholar 
Affiliation  Jammu Institute Of Ayurveda And Research 
Address  P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123

Jammu
JAMMU & KASHMIR
181123
India 
Phone  8899576374  
Fax    
Email  sakshiaditi4516@gmail.com  
 
Source of Monetary or Material Support  
Jammu Institute Of Ayurveda And Research, Nardni, Jammu, Jammu And Kashmir, 181123, INDIA 
 
Primary Sponsor  
Name  Jammu Institute Of Ayurveda And Research 
Address  Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123 
Type of Sponsor  Research institution and hospital 
 
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 Aditi Sharma  Jammu Institute Of Ayurveda And Research  P.G. Department Of Kayachikitsa, OPD and IPD of hospital Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu, Jammu And Kashmir 181123
Jammu
JAMMU & KASHMIR 		 8899576374

sakshiaditi4516@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jammu Institute Of Ayurveda And Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G431||Migraine with aura. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Pathyadi Kwatha Pana, Reference: Brahmanand Tripathi, Sharangadhara Samhita of Acharya Sharanadharacharya (Deepika Hindi commentatry), 2006edition,Varanasi,chaukambha Surbharati Prakashan, Madhyamkhanda, Dwitiyodhyaya 2/143-145. Page No. 24, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Follow up :- on 15th day, 30th day and 45th day -Drug free Follow up :- on 45th day
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtang sangrah, Procedure details: 6 drops of Kwatha in each nostril for 5 days and then 5 days washout period and repeat this three times in 30 days.)
(1) Medicine Name: Pathyadi kwatha, Reference: Bhavaparkash, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of either sex of age between 18 years to 60 years.
2.Patients with clinical features of Ardhavbhedaka i.e.Headache,Nausea ,Vomitting,Aura.
3.Patients with Chronicity of disease more than 6 months and less than 3 years.
4.Patients willing to participate and able to provide signed informed consent.

 
 
ExclusionCriteria 
Details  1.Patients who are suffering from Hypertension, Diabetes Mellitus and likewise other Chronic diseases.
2.Patients suffering from Cervical Spondolysis,Middle ear infections,Trigeminal Neuralgia and Refractive error.
3.Patients suffering from Fever,Sinusitis.
4.Patients suffering from Secondary Headaches caused by Meningitis,Tumour Encephalitis.
5.Patients with history of Head injury and Brain Infections.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in subjective parameters of Ardhavbhedaka
Subjective:1.Severity of headache.
2.Frequency of Headache : Assessed in terms of Frequency in days
3.Duration of Headache : Assessed in terms of Hours/day
4.Nausea
5.Vomiting
6.Vertigo
7.Aura
 		 Assessment: Percentage relief in symptoms and signs after 30 days of
treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Overall Percentage Improvement Score
2.Patient-Reported Quality of Life Improvement 		 Assessment after the Drug Free follow up at 45th day. 
 
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 2 
Date of First Enrollment (India)   01/05/2026 
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="6"
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   The proposed study is a randomized, open-label, comparative clinical trial designed to evaluate and compare the efficacy of Pathyadi Kwatha Nasya and Pathyadi Kwatha Pana in the management of Ardhavbhedaka (Migraine). Ardhavbhedaka, described in classical Ayurvedic texts as a severe unilateral headache involving the Manya, Bhru, Shankha, Karna, Akshi, and Lalata regions, closely correlates with migraine in contemporary medicine. Given the rising prevalence of migraine and limitations of modern pharmacotherapy, this study aims to explore safe and holistic Ayurvedic interventions. Thirty patients fulfilling diagnostic criteria will be randomly allocated into two groups—Group A receiving Pathyadi Kwatha Nasya and Group B receiving Pathyadi Kwatha Pana for 30 days. Assessment will be conducted using validated subjective parameters including severity, frequency, duration of headache, nausea, vomiting, vertigo, and aura. Outcomes will be analyzed statistically to determine therapeutic effectiveness and comparative superiority, thereby contributing to evidence-based management of Ardhavbhedaka through Ayurveda. 
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