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)â€. |
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
|
|
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
|
|
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 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (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)
| 2 | Intervention Arm | Procedure | - | AByantarasnehaH , आà¤à¥à¤¯à¤¨à¥à¤¤à¤°Â सà¥à¤¨à¥‡à¤¹à¤ƒ | (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. |