| CTRI Number |
CTRI/2026/01/102174 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomised Study To See If The Dadimadi Ayurvedic Regimen And Medicated Ghee Nasal Drops Help Relieve Allergy Symptoms In Children.
|
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Scientific Title of Study
|
A Randomised Controlled Study To Evaluate The Efficacy of Dadimadi Yoga and Panchalavana Siddha Ghrita Nasya 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 Swagatika Swain |
| Designation |
Junior Resident |
| Affiliation |
Institute Of Medical Science Banaras Hindu University |
| Address |
Department of Kaumarbhritya Balaroga Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7735944817 |
| Fax |
|
| Email |
swagatikaswain3124@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Patni |
| Designation |
Assistant Professor |
| Affiliation |
Institute Of Medical Science Banaras Hindu University |
| Address |
Department of Kaumarbhritya Balaroga Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9456140578 |
| Fax |
|
| Email |
kalpana.patni@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Patni |
| Designation |
Assistant Professor |
| Affiliation |
Institute Of Medical Science Banaras Hindu University |
| Address |
Department of Kaumarbhritya Balaroga Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9456140578 |
| Fax |
|
| Email |
kalpana.patni@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University Varanasi |
| Address |
Department Of Kaumarbhritya Balaroga Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University Varanasi (U.P.) INDIA 221005 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swagatika swain |
Sir Sundarla Hospital BHU |
OPD No 25 Kaumarbhritya Balaroga OPD Department Of Kaumarbhritya Balaroga Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University
Varanasi
UTTAR PRADESH |
7735944817
swagatikaswain3124@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute Of Medical Science Institutional Ethics Committee Varanasi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Levocetirizine dihydrochloride | Name/agent: Levocetirizine dihydrochloride (oral syrup/tablet).
Dosage form/strength: Syrup 2.5 mg/5 mL or tablet 5 mg (as age-appropriate).
Route: Oral.
Dose and frequency:
4–6 years: 0.125 mg/kg once daily (given as syrup).
6–12 years: 2.5 mg once daily.
Administration time: Evening, after food.
Duration: 60 days.
Concomitant meds: Avoid other antihistamines/decongestants/intranasal steroids during the study; normal saline nasal irrigation permitted; rescue medication per protocol | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Sushruta Samhita, Procedure details: Panchalavana Siddha Ghrita Nasya (Pratimarsha Nasya)
Dose: 2 drops in each nostril (approx. 0.08–0.1 mL/nostril), once daily.
Route: Intranasal (nasya), administered by a qualified Ayurveda physician.
Administration details: Child supine with head low; gentle nasal clearance prior; remain 1–2 minutes post-instillation; avoid nose blowing for ~30 minutes.
Duration: 60 days.
Preparation/quality: Ghrita prepared as per classical method; GMP-certified pharmacy; stored in amber bottle at room temperature.)
(1) Medicine Name: Dadimadi Yoga, Reference: Ashtanga Hridayam, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 60 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dadimadi Yoga, Reference: Ashtanga Hridayam, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
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Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged 4-12 yrs of either sex
Patients diagnosed with allergic rhinitis
Parents submitting written consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Children with any genetic disease
Any chronic diseases like Tuberculosis, COPD and Pneumonia.
Nasal polyp
Allergic rhinitis associated with immunodeficiency like HIV
Any other systemic illness |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in total IgE level and Absolute eosinophil count
Response in the improvement of signs and symptoms |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life |
60 days |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
19/02/2026 |
| 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
|
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Brief Summary
|
Allergic Rhinitis is an inflammatory disorder of the nasal mucosa marked by nasal congestion, rhinorrhea, and itching, often accompanied by sneezing and conjunctival inflammation. Its recognition as a major chronic respiratory disease of children derives from its high prevalence, detrimental effects on quality of life and school performance,and comorbidities. Children with Allergic Rhinitis often have related conjunctivitis, sinusitis, otitis media, serous otitis, hypertrophic tonsils and adenoids, and eczema. Two factors necessary for the expression of Allergic Rhinitis are sensitivity to an allergen and the presence of the allergen in the environment. Allergic Rhinitis classification as seasonal or perennial is giving way to the designations intermittent and persistent. The 2 sets of terms are based on different suppositions, but inhalant allergens are the main cause of all forms of Allergic Rhinitis , irrespective of terminology. |