CTRI Number |
CTRI/2025/06/089198 [Registered on: 20/06/2025] Trial Registered Prospectively |
Last Modified On: |
19/06/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effect of Ashwabaladi Ghrita Nasya and Anu Tail Nasya in the Management of Vataja Pratishyaya (Allergic Rhinitis) |
Scientific Title of Study
|
Evaluation of Comparative efficacy of Ashwabaladi Ghrita Nasya versus Anu Tail Nasya in the management of Vataja Pratishyaya (Allergic Rhinitis) |
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 Megha Tidke |
Designation |
Assistant Professor |
Affiliation |
Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha |
Address |
Room No 24 Shalakya Tantra OPD Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha Maharashtra India
Wardha MAHARASHTRA 442001 India |
Phone |
08329011170 |
Fax |
|
Email |
megha.tidke61@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pramod Borghare |
Designation |
professor |
Affiliation |
Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha |
Address |
Room No 24 Shalakya Tantra OPD Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha Maharashtra India
Wardha MAHARASHTRA 442001 India |
Phone |
9881225532 |
Fax |
|
Email |
drpramodborghare@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Pramod Borghare |
Designation |
professor |
Affiliation |
Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha |
Address |
Room No 24 Shalakya Tantra OPD Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha Maharashtra India
Wardha MAHARASHTRA 44 India |
Phone |
9881225532 |
Fax |
|
Email |
drpramodborghare@hotmail.com |
|
Source of Monetary or Material Support
|
Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha,Maharashtra,India 442001 |
|
Primary Sponsor
|
Name |
DrMegha Tidke |
Address |
Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha,Maharashtra,India 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 |
DrMegha Tidke |
Mahatma Gandhi Ayurveda College, hospital and Research Centre salod wardha,Maharashtra,India 442001 |
Room No 24 Shalakya Tantra OPD Mahatma Gandhi Ayurved Hospital Salod H Wardha Wardha MAHARASHTRA 422001 India Wardha MAHARASHTRA |
8329011170
drpramodborghare@hotmail.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:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ashwabaladi Ghrita, Reference: NA, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Anu , Reference: Charak Samhita Sutrasthan 5 /63-70, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Aged between 20to 60 years
Diagnosed as a case of Vataja Pratishyaya Allergic Rhinitis ICD 10 code J 30.9 will be selected irrespective of gender occupation and socio-economic status
Patients who complained of Allergic Rhinitis for more than 6 months
Patients who are fit for Nasya karma Nasyarha
Only those patients are willing to give informed consent
|
|
ExclusionCriteria |
Details |
Individuals suffering from additional allergy conditions such bronchial asthma or allergic purpura with nasal conchae DNS and nasal polyps
Individuals who are allergic to heterologous proteins
Individuals receiving steroid treatment
Suffering from additional biological conditions such AIDS vascular malformations hypertension diabetes mellitus hematologic abnormalities malignant tumors or mental illnesses
Rajaswala pregnant women women who were ready to conceive during the last six months and nursing mothers
Patients for whom Nasya is contraindicated
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in IgE level Total Nasal Symptom Score TNSS |
12 Weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Rhinoconjunctivitis Quality of Life Questionnaire RQLQ
Decrease in IgE level AEC Absolute Eosinophil Count
|
12 Weeks |
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
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)
|
24/11/2025 |
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="0" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [megha.tidke61@gmail.com].
- For how long will this data be available start date provided 18-12-2026 and end date provided 31-12-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
This study aims to evaluate and compare the efficacy of Ashwabaladi Ghrita Nasya and Anu Taila Nasya in managing Vataja Pratishyaya Allergic Rhinitis It is a randomized controlled clinical trial involving 104 participants aged 20–60 years, divided equally into two groups The intervention group receives Ashwabaladi Ghrita Nasya, and the control group receives Anu Taila Nasya. The trial assesses outcomes like Total Nasal Symptom Score (TNSS), IgE AEC levels and quality of life using the RQLQ scale Ashwabaladi Ghrita with its immunomodulatory and Vata shamaka properties is expected to provide better symptomatic relief The study duration is 10 weeks with a follow up on the 90th day If successful it may offer a safer natural alternative to conventional steroidal treatments. |