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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther 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: -
2Comparator ArmDrugClassical(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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [megha.tidke61@gmail.com].

  6. 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.

  7. 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.

 
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