| CTRI Number |
CTRI/2025/07/090589 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare the Effectiveness of Two Ayurvedic Nasal Therapies—Panchagavya Ghrita and Shadbindu Tail—in Managing Tension-Type Headache (Vataj Shirashoola), Considering Mental Strength (Sattva) |
|
Scientific Title of Study
|
Generation of Empirical Evidence in relation to Sattva Parikshan by Comparing Efficacy of Panchagavya Ghrita Nasya (Nasal Drops) against Shadbindu Tail Nasya in the Management of Vataj Shirashoola (Tension Type Headache) through RCT |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanashree vikas Ravekar |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research centre |
| Address |
Shalakya Tantra OPD Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India
Shalakya Tantra OPD Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
09763696560 |
| Fax |
|
| Email |
dhanashreehiwrale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dnyanesh Joshi |
| Designation |
Professor in Samhita Sidhanta Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research centre |
| Address |
Shalakya Tantra OPD Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India
Shalakya Tantra OPD Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8087374390 |
| Fax |
|
| Email |
dnyaneshj9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhanashree vikas Ravekar |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research centre |
| Address |
Shalakya Tantra OPD Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India
Shalakya Tantra OPD Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
09763696560 |
| Fax |
|
| Email |
dhanashreehiwrale@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Dhanashree Ravekar |
| Address |
Mahatma Gandhi Ayurved College Hospital & Research Center, Salod (H), Wardha, Maharashtra, 442001 |
| Type of Sponsor |
Other [self] |
|
|
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 Dhanashree Ravekar |
Shalakya OPD, Mahatma Gandhi Ayurved College, Hosptial and Research center, Salod(H), |
Shalakya OPD, Mahatma Gandhi Ayurved College, Hosptial and Research center, Salod(H), Wardha
Wardha
MAHARASHTRA |
9763696560
dhanashreehiwrale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: VATAJA-SIROROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchagavya Ghrita, Reference: Apasmaar Chuikitsa Adhyaya, Charak Chikitsa Sthan, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shadabindu Tail, Reference: NA, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, 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. Clinically diagnosed Vataj Shirashoola, with Pravara, Madhyam, Awara Satwa patients as per Satwa Parikshan
2. Patients fit for Nasya karma |
|
| ExclusionCriteria |
| Details |
1.Patients with underlying any other pathological conditions e.g., Meningitis, trauma, space occupying lesions etc.
2. Chronic sinusitis
3.Pregnant women, lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief from Vataj Shirashoola (Tension-Type Headache) with improvement
in Quality of Life
|
30 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess relief from Vataj Shirashool In all three types of Sattva- Pravara, MAdhyam, Avara Sattva |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
22/10/2025 |
| 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="2"
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
|
This study aims to compare the efficacy of Panchagavya Ghrita and Shadabindu tail in Vataj Shirashool of Pravara Sattva, Madhyam Sattva, and Avara Sattva patients. The interventional group will recieve Panchagavya Ghrita nasya and control group will receive Shadabindu tail nasya. The duration of the treatment will be for 30 days, in which 2 drops will be administered in each nostril daily. The outcome of the study will be improvemant in the Quality of Life. If the Interventional drug proves better than the control group then it may offer a better alternative for conventional allopathic treatment. |