| CTRI Number |
CTRI/2025/07/091099 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparitive Clinical Study Of Hingwadi Taila And Shuntyadi Taila As Nasal Drops In Allergic Rhinitis |
|
Scientific Title of Study
|
An Open Label Double Arm Randomized Clinical Study To Compare The Efficacy Of Hingwadi Taila Nasya And Shuntyadi Taila Nasya In Vataja Pratishyaya W S R To 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 Shruti H K |
| Designation |
Pg Scholar |
| Affiliation |
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre |
| Address |
OPD No-21
Department of shalakya tantra
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre bangalore
10 pipeline road r p c layout vijayanagar bangalore
Bangalore KARNATAKA 560104 India |
| Phone |
9632034919 |
| Fax |
|
| Email |
hk.shruti98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hamsaveni V |
| Designation |
Professor |
| Affiliation |
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre |
| Address |
Department of shalakya tantra
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre bangalore
10 pipeline road r p c layout vijayanagar bangalore
Bangalore KARNATAKA 560104 India |
| Phone |
9900110912 |
| Fax |
|
| Email |
vimalbut@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Hamsaveni V |
| Designation |
Professor |
| Affiliation |
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre |
| Address |
Department of shalakya tantra
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre bangalore
10 pipeline road r p c layout vijayanagar bangalore
Bangalore KARNATAKA 560104 India |
| Phone |
9900110912 |
| Fax |
|
| Email |
vimalbut@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Shruti H K
Room No 21 Dept Of Pg Studies In Shalakya Tantra
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104 |
|
|
Primary Sponsor
|
| Name |
Dr Shruti H K |
| Address |
Room No 21 Dept Of Pg Studies In Shalakya Tantra
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104 |
| Type of Sponsor |
Other [Dr Shruti H K] |
|
|
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 Kiran M Goud |
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre bangalore |
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre bangalore
10 pipeline road r p c layout vijayanagar Bangalore
Bangalore KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| skamchrc |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Astanga Hrudaya, Procedure details: Nasya Karma is a therapeutic procedure in Ayurvedic medicine that involves the administration of medicated substances through the nasal route) (1) Medicine Name: Hingwadi Taila, Reference: Basavarajeeyam, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Nasya | (Procedure Reference: Astanga Hrudaya, Procedure details: Nasya Karma is a therapeutic procedure in Ayurvedic medicine that involves the administration of medicated substances through the nasal route ) (1) Medicine Name: Shuntyadi Taila, Reference: Astanga Hrudaya , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with lakshanas of vataja pratishyaya
Subjects with clinical features of allergic rhinitis
Subjects fit for Nasya Karma |
|
| ExclusionCriteria |
| Details |
Subjects with Nasal polyps and malignancies
Subjects with other systemic diseases which interferes with the course of treatment
Pregnant and lactating mother
Subjects presenting with Ama Pratishyaya lakshanas |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the reduction in nasal discharge, nasal obstruction, sneezing, itching of the nose, transverse nasal crease, nasal mucosal pallor, nasal mucosal oedema through nasal endoscopy and other parameters with the help of two modalities Hingwadi taila nasya and Shuntyadi taila nasya in vataja pratishyaya
w s r to Allergic Rhinitis |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
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)
|
15/05/2026 |
| 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="2" Months="1" Days="1" |
|
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, as described in the Pratishyaya Pratishedha Adhyaya of the Sushruta Samhita, presents with classical symptoms such as nasal obstruction (Aanaddha Pihita Nasa), thin watery nasal discharge (Tanusrava Pravartini), dryness of the throat and palate (Galataluosta Shosha), frontal headache (Shankha Nistoda), and hoarseness of voice (Swaropaghata). These clinical features closely resemble Allergic Rhinitis, a common condition in modern medicine. Allergic Rhinitis is an IgE-mediated Type I hypersensitivity reaction of the nasal mucosa triggered by airborne allergens. It is commonly characterized by nasal congestion, rhinorrhea, sneezing, and itching in the nose, eyes, palate, pharynx, and ears. In Ayurveda, Nasya Karma (nasal administration of medicated oil) is regarded as the primary line of treatment for diseases affecting the Urdhwajatrugata (region above the shoulders). Among the classical formulations, Hingwadi Taila and Shuntyadi Taila are prominently indicated in Vata-Kapha dominant disorders. Both oils are attributed with properties such as Vata-Kapha hara (dosha-pacifying), Shotha hara (anti-inflammatory), and Shoola prashamana (analgesic). Given the non-invasive nature and therapeutic potential of Nasya therapy, the present study aims to compare the clinical efficacy of Hingwadi Taila Nasya and Shuntyadi Taila Nasya in the management of Vataja Pratishyaya, with special reference to Allergic Rhinitis. |