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CTRI Number  CTRI/2025/03/083054 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening 
Study Design  Single Arm Study 
Public Title of Study   Managing Migraine through Ayurveda: Insights on Ardhavabhedaka and the Therapeutic Role of Vidangadi Taila and Shiro Lepa 
Scientific Title of Study   "Etiopathological Study of Ardhavabhedaka (Migraine) and Evaluation of the Therapeutic Effect of Vidangadi Taila Nasya and Vidangadi Shiro Lepa"  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sabita Pradhan 
Designation  PG Scholar 
Affiliation  Government Ayurvedic College and Hospital Balangir Odisha India 
Address  Post Graduate Department of Roga Nidana Evum Vikriti Vigyana Government Ayurvedic College and Hospital Balangir Odisha India

Balangir
ORISSA
767001
India 
Phone  6371654842  
Fax    
Email  sabitasumi14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Sarita Mohanta 
Designation  Professor 
Affiliation  Government Ayurvedic College and Hospital Balangir Odisha India 
Address  Post Graduate Department of Roga Nidana Evum Vikriti Vigyana Government Ayurvedic College and Hospital Balangir Odisha India

Balangir
ORISSA
767001
India 
Phone  8144848636  
Fax    
Email  sagar.siba2010@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sabita Pradhan 
Designation  PG Scholar 
Affiliation  Government Ayurvedic College and Hospital Balangir Odisha India 
Address  Post Graduate Department of Roga Nidana Evum Vikriti Vigyana Government Ayurvedic College and Hospital Balangir Odisha India


ORISSA
767001
India 
Phone  6371654842  
Fax    
Email  sabitasumi14@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College and Hospital Balangir Odisha 
 
Primary Sponsor  
Name  Sabita Pradhan 
Address  Post Graduate Department of Roga Nidana Evum Vikriti Vigyana Government Ayurvedic College and Hospital Balangir Odisha 767001 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
Government Ayurvedic College and Hospital Balangir Odisha  Government Ayurvedic College and Hospital Balangir Odisha 767001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sabita Pradhan  Government Ayurvedic College and Hospital Balangir Odisha  IPD and OPD of Roganidan Evum Vikriti Vigyan
Balangir
ORISSA 		 6371654842

sabitasumi14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurvedic College and Hospital Balangir  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vidangadi Taila Nasya and Vidangadi Shirolepa, Reference: Yogaratnakara Uttartantra Shiroroga Chikitsa Adhyaya, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having the classical signs and symptoms of Ardhavabhedaka and Migraine
Patient between 16 to 60 years
Patient of either sex 
 
ExclusionCriteria 
Details  Patients age less than 16 years and more than 60 years
Patient suffering from other types of headaches
Patient suffering from sinusitis hypertension and fever secondary headache caused by meningitis tumour encephalitis cervical spondylitis and refractive errors
Patients using any other systemic drugs which may alter the results of the study

 
 
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 
Reduction of pain in head  In 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in photophobia phonophobia filling of nausea aura and associated symptoms  30 days 
 
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   N/A 
Date of First Enrollment (India)   01/04/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Nil

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This is an etiopathological study of Ardhavabhedaka W.S.R. to Migraine and to evaluate the Upasaya effect of Vidangadi Taila Nasya and Vidangadi Shirolepa. This is done compulsory part of Post Graduate Course. Total number of patients to be studied is 30 with duration of 30 days.This is single arm interventional study. Purpose of the study is the ayurvedic management of migraine 
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