| CTRI Number |
CTRI/2025/09/095246 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study On Treatment of Vattaj Shirashool With Special Reference to Tension Headache |
|
Scientific Title of Study
|
A Comparative Clinical Study To Asses The Efficacy Of Shirashooladi Vajra Rasa Along With Devdarvyadi Roll On And Shirashooladi Vajra Rasa In Vattaj Shirashool WSR To Tension Headache |
| 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 PRAJAKTA SHRINIVAS PARUNDEKAR |
| Designation |
Post Graduate Scholar |
| Affiliation |
Dr DY Patil School of AyurvedaDeemed To Be University ,Nerul ,Navi Mumbai 400706 |
| Address |
Opd No 5 1st floor Department of Shalakyatantra Dr DY Patil School of Ayurveda Deemed To Be UniversitSector7NerulNavi Mumbai Maharashtra India 400706
Thane
MAHARASHTRA
400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9834354425 |
| Fax |
|
| Email |
parundekarprajakta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUGDHA SAWLE |
| Designation |
Associate Professor,Shalakya Tantra Dept,D.Y.Patil School Of Ayurveda ,Deemed To Be University |
| Affiliation |
Dr DY Patil School of AyurvedaDeemed To Be University Nerul Navi Mumbai 400706 |
| Address |
Opd No 5 1st floor Department of Shalakyatantra Dr DY Patil School of Ayurveda Deemed To Be UniversitySector7NerulNavi Mumbai Maharashtra India 400706
Thane
MAHARASHTRA
400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9892079391 |
| Fax |
|
| Email |
mugdha.sawle@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR MUGDHA SAWLE |
| Designation |
Associate professor ,shalakyatantra Department |
| Affiliation |
Dr DY Patil school of Ayurveda Deemeed to be Univerity Nerul Navi Mumbai 400706 |
| Address |
Opd No 5 1st floor Department of shalakyatantra Dr DY patil school of ayurveda Deemed To be University sector 7 nerul navi Mumbai maharashtra India
Thane
MAHARASHTRA
400706
India |
| Phone |
9892079391 |
| Fax |
|
| Email |
mugdha.sawle@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| DR DY Patil school of Ayurveda and Hospital,Deemed to be university ,sector 7,Nerul,Navi Mumbai,Maharashtra India 400706 |
|
|
Primary Sponsor
|
| Name |
Dr DY Patil school of Ayurveda Deemed to be University |
| Address |
Dr DY Patil school of Ayurveda and Hospital,Deemed to be university ,sector 7,Nerul,Navi Mumbai,Maharashtra 400706 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 PRAJAKTA SHRINIVAS PARUNDEKAR |
D Y Patil Ayurvedic Hospital Navi Mumbai |
Department of Shalakya Tantra First Floor OPD NO 05 Thane MAHARASHTRA
Thane
MAHARASHTRA |
9834354425
parundekarprajakta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee DY Pati school of ayurveda deemed to be university Nerul Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G442||Tension-type headache. Ayurveda Condition: VATAJA-SIROROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHIRASHOOLADI VAJRA RASA, Reference: BHAISHAJYARATNAVALI SHIROROGADHIKAR, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: HONEY), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DEVDARVYADI ROLL ON , Reference: SHARANGADHAR SAMHITA TRITIYA KHANDA , Route: Topical, Dosage Form: Taila, Dose: 4(drops), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient of either sex or aged between 18 to 60yrs
2)Patient willing and able to participate in study
3)Patients presenting with symptoms of tension headache and vataj shirashool as described in subjective criteria |
|
| ExclusionCriteria |
| Details |
1)Age group less than 18 years and more than 60 years
2)Patient is not willing to participate in study
3)Patients with underlying pathological conditions like trauma Meningities Brain tumors Migraine headache through refractive errors will be excluded
4)Patient with history of addictive drugs drinks smokers alcohol consumers
5)Pregnant and lactating women
6)Through subjective criteria scoring 4&5 very severe and most severe pain will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of clinical symptoms-pain at temporal region ,pain in center of forehead,pain aggravated at night time ,stiffness in neck region ,phtophobia,giddiness
2)Improvement in Headache impact score 6 test filled n 1st and last day of follow up
3)Improvement in range of neck motion criteria |
28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence of clinical symptoms of vattaj shirashool -pain in temporal region,pain in centre of forehead,pain aggravated at night time,stiffness in neck region photophobia,giddiness |
28 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/10/2025 |
| 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 - NO
|
|
Brief Summary
|
TITTLE -A COMPARATIVE CLINICAL STUDY TO ASSES THE EFFICACY OF SHIRASHOOLADI VAJRA RASA ANLONG WITH DEVDARVYADI ROLL ON AND SHIRASHOOLADI VAJRA RASA IN VATTAJ SHIRASHOOL WSR TO TENSION HEADACHE The effectiveness of shirashooladi vajra rasa alone vs the combination of Devdarvyadi roll on and Shirashooladi vajra rasa in Vattaj Shirashool with tension headache can be studied .Snehan is main chikitasa in vataja shirashool so devdarvyadi roll on contains all the drugs that pacify the vatta dosha and to make it more fesiable we will convert it into roll on .Total 30 patients will be added in both groups group A will receive Devdarvyadi roll on and shirashooladi vajra rasa Group B will receive only shirashooladi vajra rasa .During first day of assesment patients will be selected on the basis of symptoms of vattaj shirashool pain at forehead pain in temporal region pain at night etc; range of neck motion criteria will also be noted and headache impact test score will be filled on 1st and last day to asses the progress. Outcomes will be assess on improvement in range of neck motion and reduction in symptoms of vattaj shirashool and improvement in Headache impact test |