| CTRI Number |
CTRI/2026/02/103138 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the Effect of Katutaila and Anutaila Pratimarsha Nasya in Allergic rhinitis in Occupations Exposed to Dust |
|
Scientific Title of Study
|
A Randomized clinical study on the efficacy of Katutaila and Anutaila Pratimarsha Nasya in Allergic rhinitis in Occupations exposed to dust |
| 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 G |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital koppall |
| Address |
OPD NO 5 Ground floor Department of Swasthavritta Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal Karnataka 583231
Koppal KARNATAKA 583231 India |
| Phone |
9611934493 |
| Fax |
|
| Email |
meghagkalal333@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prabhu C Nagalapur |
| Designation |
Professor |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital koppal |
| Address |
OPD NO 5 Ground floor Department of Swasthavritta Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal Karnataka 583231 OPD No 5 Ground floor Department of Swasthavritta Shree Jagadguru Gavisiddeshwara Ayurvedic medical College and Hospital Koppal Karnataka 583231 Koppal KARNATAKA 583231 India |
| Phone |
9483315576 |
| Fax |
|
| Email |
asha57dsa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Somanath |
| Designation |
Professor |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital koppal |
| Address |
OPD NO 5 Ground floor Department of Swasthavritta Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal Karnataka 583231
Koppal KARNATAKA 583231 India |
| Phone |
9036199959 |
| Fax |
|
| Email |
dr.somu.the.moon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal |
|
|
Primary Sponsor
|
| Name |
Dr Megha g |
| Address |
OPD No 5 Ground floor Department of Swasthavritta Shree Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal Karnataka 583231 |
| 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 |
| Dr Megha G |
Shree Jagadguru Gavisiddeshwara Ayurvedic medical hospital |
OPD No 5 Ground floor Department of Swasthavritta Shree Jagadguru Gavisiddeshwara Ayurvedic medical College and hospital Koppal Karnataka 583231 Koppal KARNATAKA |
9611934493
meghagkalal333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Sushruta chikitsa 40/21, Procedure details: Katu taila pratimarsha nasya instilled in each nostrils) (1) Medicine Name: Katu taila, Reference: Yogaratnakra purvardha Dinacharya Adhyaya 34-35, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(ml), Frequency: od, Duration: 60 Days | | 2 | Comparator Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Sushruta samhita chikitsasthana 40/21, Procedure details: Anutaila pratimarsha nasya instilled in each nostril) (1) Medicine Name: Anutaila , Reference: Charaka samhita sutrasthana 5/58-62, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(ml), Frequency: od, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are regularly exposed to dust due to their occupation
Individuals with history of recurrent Allergic rhinitis
Symptoms including sneezing rhinorrhoea nasal congestion and nasal itching |
|
| ExclusionCriteria |
| Details |
Patients unfit for Nasya
COPD Asthma Pneumonia other infectious respiratory illness
DM HTN and other acute or chronic systemic illness Congenital anomalies structural or anatomical abnormalities of organs of URT
History of nasal surgery
Smokers Tobacco or alcohol users |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Katu taila Pratimarsh nasya would be very effective in reduction of the episodes of Allergic rhinitis in different occupations exposed to dust |
120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in entry of dust particle in the respiratory tract or deposition in the nasal mucosa following Pratimarsha nasya and thus prevent occurrence of Allergic rhinitis |
60 Days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/03/2026 |
| 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="0" Months="4" 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
|
Recurrent upper respiratory tract infections are a significant public health concern particularly among individuals in occupations with high exposure to environmental dust such as Traffic police construction workers street vendors sweepers Studies have shown that continuous inhalation of dust leads to inflammation of the nasal mucosa impaired mucociliary clearance and reduced local defense mechanisms As per the American College of Allergy Asthma and Immunology ACAAI allergic rhinitis has increased 100 percentage in each of the last three decades According to World Allergy Organisation WAO 400 million persons worldwide have Allergic rhinitis In India 26 percentage of population suffers from Allergic rhinitis Current therapeutic modalities for the management of Allergic rhinitis includes antihistamines decongestants mast cell stabilizers leukotriene receptor antagonists corticosteroids and anticholinergic agents in oral or topical nasal formulations But all these drugs give only symptomatic relief and none of these are free from adverse effects Long term corticosteroid use may cause mucosal thinning and systemic side effects In Ayurveda Pratimarsa Nasya a gentle daily nasal administration of medicated oil is described as a part of Dinacharya to maintain Urdhwajatrugata Bala protect nasal mucosa and prevent disease onset Anutaila is particularly known for its Tridoshaghna Indriya balaprada properties as the administered drug intranasally enters the nasal cavity through superior middle and inferior meatus which further stimulates six sinus openings all through and doshavilayana liquification of doshas is readily seen along with absorption of drug essence to exert the action The Katu taila being Sukshma guna enters the minutest channels of the body and it also get absorbed easily because of Snigdha guna and may also obstruct the entry of dust into the nasal cavity Due to Ushna veerya of Katu taila it pacifies Vata dosha Ushna guna of Katu taila also has Viliniam kurvanti property hence it softens and liquefies the morbid doshas and expel out through Nasya Karma Regular use of Katu taila promotes smooth functioning of sense organs and lightness in Urdhwajatru upper region Vimalendriya Brings purity to sense organs Katu taila may be cost effective due its fewer ingredients than Anutaila Hence there is a need to evaluate simple procedures of Dinacharya through a systematic clinical study and prove its preventive effect This study aims to evaluate the effectiveness of both Anutaila Pratimarsha nasya and Katu taila Pratimarsha nasya in reducing the frequency and duration of Allergic Rhinitis in individuals from different dusty occupational backgrounds |