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CTRI Number  CTRI/2022/03/041061 [Registered on: 14/03/2022] Trial Registered Prospectively
Last Modified On: 11/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic Management for Migraine (Ardhavabhedaka). 
Scientific Title of Study   “A comparative evaluation on efficacy of Brihat Dashmoola Taila Snehapana and Brihat Dashmoola Taila Nasya in the management of Ardhavabhedaka (Migraine)”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati 
Designation  PG Scholar 
Affiliation  Ch. Brahm Prakash Ayurved Charak sansthan 
Address  PG Dept. of Panchkarma, Ch. Brahm Prakash Ayurved Charak sansthan, Khera Dabar, Najafgarh

South West
DELHI
110073
India 
Phone  9983257427  
Fax    
Email  snahliya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Arun Gupta 
Designation  Professor and Head of Department 
Affiliation  Ch. Brahm Prakash Ayurved Charak sansthan 
Address  Room no. 142, PG Dept. of Panchkarma, Ch. Brahm Prakash Ayurved Charak sansthan, Khera Dabar, Najafgarh

South West
DELHI
110073
India 
Phone  8178361290  
Fax    
Email  arun24@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Arun Gupta 
Designation  Professor and Head of Department 
Affiliation  Ch. Brahm Prakash Ayurved Charak sansthan 
Address  Room no. 142,PG Dept. of Panchkarma, Ch. Brahm Prakash Ayurved Charak sansthan, Khera Dabar, Najafgarh

South West
DELHI
110073
India 
Phone  8178361290  
Fax    
Email  arun24@hotmail.com  
 
Source of Monetary or Material Support  
Ch Brahm Prakash Ayurved charak Sansthan 
 
Primary Sponsor  
Name  Ch Brahm Prakash Ayurved charak Sansthan 
Address  Ch Brahm Prakash Ayurved charak Sansthan, Khera Dabar, Najafgarh, New Delhi- 110073 
Type of Sponsor  Government medical college 
 
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 Swati  Ch Brahm Prakash Ayurved Charak Sansthan  Room no. 123, PG Department of Panchakarma, Ch Brahm Prakash Ayurved Charak Sansthan khera dabar, Najafgarh 110073
South West
DELHI 
9983257427

snahliya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CBPACS  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
1Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charak Samhita, Procedure details: (Procedure References Charaka samhita, Procedure details: Purva karma- Prepare the patient for Mukhabyanga by Tila oil extending it to neck and shoulder Nadi sweda with Dashmool kwath. Protections of eyes are taken during swedan. Ask patient to sit or lie down in a relaxed position. Pradhan karma- Brihat Dashmoola Taila Nasya 8 bindu(~4ml) in each nostril, two sittings for 7 days each with 7 days of gap period and follow up on 28th day. Paschat karma- Dhoomapana and Kavalgraha are done with luke)
2Intervention ArmProcedure-AByantarasnehaH , आभ्यन्तर स्नेहः (Procedure Reference: Charak Samhita, Procedure details: Brihat Dashmoola Taila Snehapana 2 karsha (~20ml) two sitting for 7 days each with 7 days of gap period and follow up on 28th day.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patient having the sign and symptoms of Ardhavabhedaka as mentioned in the literature.
2. Having recurrent attack of headache.
3. With or without nausea, vomiting, aura.
4. Patient of the both genders between age group of 20 - 50 yrs.
5. Patient fit for Nasya Karma.
 
 
ExclusionCriteria 
Details  1. Age group less than 20 and more than 50 yrs.
2. Patient suffering from any other types of Headaches.
3. Patient unfit for Nasya Karma as mentioned in Ayurvedic reference books.
4. Patient having history of Head Trauma.
5. Pregnant women and Lactating mothers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Brihat Dashmoola Taila Snehapana shows improvement on subjective symptoms like severity of headache, frequency of headache, duration of headache.  0, 7th, 21th, 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
Brihat Dashmoola Taila Snehapana shows improvement on other associated symptoms of migraine like vertigo, vomiting, nausea and aura.
 
0th, 7th, 21th, 28th day 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   25/03/2022 
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   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study is to compare the effect of Brihat Dashmoola Taila Snehapana and Brihat Dashmoola Taila Nasya in the management of Ardhavabhedaka. In one group Brihat Dashmoola Taila Snehapana in the dose of 2 karsha (~20 ml) OD  daily for 7 days in two sitting will be given. In another group Brihat Dashmoola Taila Nasya for 7 days 8 bindu (~4ml) in each nostril in two sitting will be given. The trial will be conducted in CBPACS with outcome of reduce subjective symptoms of Ardhavabhedaka mentioned in classic literature.  
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