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CTRI Number  CTRI/2026/01/101926 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Management of Allergic Rhinitis in Children 
Scientific Title of Study   Effect of Ayurvedic Management of Allergic Rhinitis in Children A Single Arm Interventional Clinical Study 
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 Happy Rameshbhai Prajapati 
Designation  P G Scholar 
Affiliation  J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital 
Address  Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, college road, Nadiad Kheda

Kheda
GUJARAT
387001
India 
Phone  9313209554  
Fax    
Email  hrprajapati37@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Rutu Patel 
Designation  Professor and HOD Department of Kaumarbhritya 
Affiliation  J S Ayurveda Mahavidalaya and P D Patel Ayurvedic Hospital 
Address  Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, college road, Nadiad Kheda

Kheda
GUJARAT
387001
India 
Phone  8200426314  
Fax    
Email  drrutu84@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Happy Rameshbhai Prajapati 
Designation  P G Scholar 
Affiliation  J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital 
Address  Department of Kaumarbhritya, J S Ayurveda Mahavidyalaya, college road, Nadiad Kheda

Kheda
GUJARAT
387001
India 
Phone  9313209554  
Fax    
Email  hrprajapati37@gmail.com  
 
Source of Monetary or Material Support  
Sundar Ayurved teaching pharmacy of J S Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital,Nadiad-387001,Gujarat,India  
 
Primary Sponsor  
Name  J S Ayurveda Mahavidyalaya 
Address  Department of Kaumarabhritya, J S Ayurved Mahavidhyalaya, College road, Nadiad-387001  
Type of Sponsor  Private medical college 
 
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 
Prof Dr Rutu Patel  P D Patel Ayurveda Hospital  Department of Kaumarbhritya, J S Ayurved Mahavidyalaya, College road, Nadiad-387001 Kheda Gujarat
Kheda
GUJARAT 		 9313209554

hrprajapati37@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-Maganbhai Adenwala Mahagujarat University, Nadiad.  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
1Intervention ArmProcedure-dhUmanasyam, धूमनस्यम् (Procedure Reference: Anubhuta yog, Procedure details: to take steam with boiled water added with yavani for 2 to 5 min twice a day. Precautions, Avoid exposure to direct & excessive wind. Avoid to take head bath with cold water. )
2Intervention ArmDrugClassical(1) Medicine Name: Balachaturbhadra churna, Reference: Govind Das Sen. (2025). Bhaishajya Ratnavali (S. Mishra, Ed., Hindi Vyakhyopeta ed., Chapter Bālarogādhikāra, Shloka 38, p. 1081). Varanasi: Chaukhambha Subharati Prakasha., Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -
(2) Medicine Name: Pathyadi Kwatha, Reference: Shaarangadhara. (2022). Shaarangadhara Samhita (Dr. Brahanand Tripathi, Ed. & Hindi Commentary, Madhyama Khanda, kashay kalpana Shlokas 143–145, pp.). Varanasi: Chaukhambha Surbharati Prakasha. , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -Guda), Additional Information: -
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. Patients with mild to moderate symptoms of Allergic Rhinitis (AR) according to Allergic Rhinitis
and its impact on asthma (ARIA) score.
2. Age group between 5 to 16 years irrespective of their gender, caste, religion and socioeconomic
status.  
 
ExclusionCriteria 
Details  1. Age Group below 5 year and above 16 years
2. Severe cases of Allergic Rhinitis associated with asthma and other disease of Lower
Respiratory tract infections including pneumonia, bronchitis.
3. Children suffering from any chronic debilitating or infectious diseases like Deviated Nasal
Septum, Nasal polyp, Sinusitis, fever (temp more than 100F), Tuberculosis, COPD, Congenital
lung and cardiac anomalies etc., which may interfere with present clinical trial.
4.Patients with history of nasal surgery.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate clinically the effect of Pathyadi Kvatha, Balachaturbhadra Churna, and Yavana Dhuma
Nasya in management of allergic Rhinitis.  		 Total duration of the study is 2 weeks of O.P.D. treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
To assess symptomatic improvement in patients with Allergic Rhinitis.  Total duration of the study is 2 weeks of O.P.D. treatment. 
 
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   N/A 
Date of First Enrollment (India)   01/02/2026 
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="6"
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   Allergic Rhinitis is one of the prime diseases of respiratory system found in all age groups irrespective of gender. Allergic Rhinitis (AR) is the most common atopic condition, affecting about 10 to 30 percent of adults and up to 40 percent of children worldwide. The conventional medical treatment of Allergic Rhinitis involves the use of antihistamines, antibiotics, nonsteroidal anti inflammatory drugs (NSAIDs), analgesics, and even corticosteroids, depending on the severity and recurrence of the disease. However, repeated and prolonged use of these medications can lead to various complications such as sedation, gastrointestinal disturbances, weakened immunity, antibiotic resistance, and other systemic side effects, thereby raising concerns about their long term safety and sustainability. Limitations of long-term antihistamines and corticosteroids in children, and considering the chronic relapsing nature of AR. Ayurveda provide holistic approach in management of AR. In Ayurveda there are multiple formulations are described for management of Pratishyaya. Interventions such as Pathyadi Kvatha, Balacaturbhadra Churna, and Yavani Dhuma Nasya may offer safe, and sustainable alternatives. The Ayurvedic principles targeting Nidana (causative factors), Samprapti (pathogenesis), and Dushyas (affected tissues) is warranted for effective prevention and management. Assessment will be done using general evaluating score and Total Nasal Symptom Score before and after treatment and the results will be analyzed statistically using Students paired t test. 
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