| CTRI Number |
CTRI/2026/03/105809 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Know the Effect of Herbal Oil Head Massage With and Without Herbal Decoction in the Management of Tension Type Headache. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study of Balahathadi Taila Shiroabhyanga With and Without Pathyakshadhatryadi Kashaya Pana in the Management of Vataja Shirashoola With Special Reference to Tension Type 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 PRATHIKSHA |
| Designation |
PG SCHOLAR |
| Affiliation |
Muniyal Institute of Ayurveda Medical Science, Manipal |
| Address |
Outpatient department of Kayachikitsa,Room no 4,Ground floor,
Muniyal instutute of ayurveda medical sciences,manipal,udupi,
Karnataka.576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986903110 |
| Fax |
|
| Email |
prathikshamr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PROF SHRIPATHI ACHARYA G |
| Designation |
Professor and Head of department |
| Affiliation |
Muniyal Institute of Ayurveda Medical Science, Manipal |
| Address |
Outpatient department of Kayachikitsa,Room no 4,Ground floor, Muniyal instutute of ayurveda medical sciences,manipal,udupi, Karnataka.576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845387720 |
| Fax |
|
| Email |
shripathi_acharya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PRATHIKSHA |
| Designation |
PG SCHOLAR |
| Affiliation |
Muniyal Institute of Ayurveda Medical Science, Manipal |
| Address |
Outpatient department of Kayachikitsa,Room no 4,Ground floor,
Muniyal instutute of ayurveda medical sciences,manipal,udupi,
Karnataka.576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986903110 |
| Fax |
|
| Email |
prathikshamr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Muniyal Institute of Ayurveda Medical Science, Manipal |
| Address |
Muniyal instutute of Ayurveda Medical Sciences,Manipal,Udupi
Karnataka.
576104
|
| 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 PRATHIKSHA |
Muniyal instutute of Ayurveda Medical Sciences,Manipal |
Outpatient department of Kayachikitsa,Room no 4,Ground floor,
Muniyal instutute of ayurveda medical sciences,manipal,udupi,
Karnataka
576104
Udupi
KARNATAKA |
9986903110
prathikshamr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| muniyal institute of ayurveda institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: SIROROGAH/SIRAHSULA/SIRASTAPA/SIROBITAPA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Balahathadi Taila, Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 00(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Balahathadi Taila massage with oral pathyakshadhatryadi kashaya. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pathyakshadhatryadi Kashaya, Reference: Sharangadhara samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with classical signs & symptoms o f Vataja shirashoola (Tension Type Headache) as mentioned in diagnostic criteria.
2.Patients aged between 18 and 60 years.
3.Patients irrespective of Gender, Religion, or occupation.
4.Patients who are willing to participate in the trial. |
|
| ExclusionCriteria |
| Details |
1.Patients pre diagnosed with Meningitis, brain tumor, encephalitis, intracranial pathologies
& also headache due to refractive errors (Eye pathologies), glaucoma, ear or nose inflammation.
2.Patients pre diagnosed with Coronary artery disease, Diabetes mellitus, and Hypertension.
3.Patients pre diagnosed with TB, HIV, cancer & other chronic illnesses.
4.Pregnant and lactating women.
5.Patients pre diagnosed with migraine, cluster headache, trigeminal neuralgia, or all other form of headache.
6.Head trauma, dental issues, Known sinusitis cases, and seizure disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the severity and frequency of headache, assessed using the Visual Analog Scale and number of headache episodes per week. |
Baseline, 30th day, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in duration of headache and associated symptoms |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/04/2026 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Tension-type headache (TTH) is the most common neurological disorder. It causes significant problems such as reduced work productivity, stress, and difficulty in daily activities. Vataja Shirashoola closely resembles tension-type headache. Ayurvedic management includes therapies like Snehana, Svedana, and Nasya, along with medicines that balance Vata. Balahathadi Taila" is a medicated oil mentioned in Sahasrayogam, This possess mainly Vathahara & Balya properties along with Tridosha Shamaka. However, there are limited clinical studies comparing the combined use of Balahathadi Taila (external therapy) with Pathyakshadhatryadi Kashaya (internal medicine) versus the Kashaya alone.Therefore, this study aims to evaluate and compare the effectiveness of these two treatment approaches in managing Vataja Shirashoola (Tension-type headache). |