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CTRI Number  CTRI/2024/04/065249 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 31/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Herbal Nasal Spray For Nasal Blockage In Children 
Scientific Title of Study   A Randomised Controlled Clinical Study To Evaluate The Efficacy Of Herbal Nasal Spray In The Management Of Allergic Rhinitis In Children 
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 Anjali Parmar 
Designation  Pg Scholar 
Affiliation  Parul Institute Of Ayurved 
Address  Opd No 103 Department of Kaumarbhritya Parul Ayurved Hospital Parul University

Vadodara
GUJARAT
391760
India 
Phone  9106369581  
Fax    
Email  anjaliparmar2501@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipeeka Surwase 
Designation  Associate Professor  
Affiliation  Parul Institute Of Ayurved 
Address  Opd No 103 Department of Kaumarbhritya Parul Ayurved Hospital Parul University

Vadodara
GUJARAT
391760
India 
Phone  9860750957  
Fax    
Email  drdipeeka77@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dipeeka Surwase 
Designation  Associate Professor  
Affiliation  Parul Institute Of Ayurved 
Address  Opd No 103 Department of Kaumarbhritya Parul Ayurved Hospital Parul University

Vadodara
GUJARAT
391760
India 
Phone  9860750957  
Fax    
Email  drdipeeka77@gmail.com  
 
Source of Monetary or Material Support  
Parul University Limda Vadodara Gujarat 391760 
 
Primary Sponsor  
Name  Parul Institute Of Ayurved 
Address  Parul Institute Of Ayurved Parul University Limda Vadodara Gujarat 391760 
Type of Sponsor  Research institution and hospital 
 
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 
DR ANJALI PARMAR  PARUL AYURVED HOSPITAL  OPD NO 103 PARUL AYURVED HOSPITAL PARUL UNIVERSITY LIMDA VADODARA 391760
Vadodara
GUJARAT 		 9106369581

anjaliparmar2501@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic 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: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Normal Saline nasal drop Saline Nasal Drops Is A Isotonic Solution Which Contains Sodium Chloride
2Intervention ArmDrugOther than Classical(1) Medicine Name: Herbal Nasal Spray , Reference: NA, Route: Nasal, Dosage Form: Sprays, Dose: 0.036(mg), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients With Symptoms Of Allergic Rhinitis Like Nasa Srava, Nasa Avarodha, Kshavathu, Kandu Associated Symptoms Like Headache & Cough 
 
ExclusionCriteria 
Details  1.Patients Suffering From Any Chronic Illness Like Asthma And Any Systemic Illness Nasal Polyp Or Any Infection And Chronic Disease Like Tuberculosis, Copd, Pneumonia,DNS
2.Patients Will Be excluded Who Are Already Taking Any Antihistamine 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in nasal blockage
 		 Relief in nasal blockage within 1 hour further assessed in every followup
at baseline
3 days
5 days
 
 
Secondary Outcome  
Outcome  TimePoints 
relief in sneezing
relief in nasal itching 		 1 day 5 day 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   11/04/2024 
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 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   Vataja pratishyaya which is generally correlated with allergic rhinitis is typically addressed with easily administered oral medications in adults, including antihistamines, 
decongestants, mast cell stabilizers, corticosteroids, and anti- cholinergic agents.
Given the vulnerability of children as a population, there is a need for heightened care and attention during repeated medicine exposure. This research addresses the 
challenges of multi route administration by exclusively adopting the nasal route, aiming for successful results.
Herbal nasal spray can be effective for the management of allergic rhinitis as compared to the contemporary medicines.
Hence, there is a need to evaluate the efficacy of ayurvedic formulation which is easy to use,which can give good result with no side effect and can decrease the recurrence
of disease.
Study Drug : Drugs like Moringa Oleifera, Berberis Aristata, Piper Longum, Glycyrrhiza Glabra Will be Collected From Vadodara And Nearby Places Since They Are Easily Available.




 
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