| CTRI Number |
CTRI/2025/07/091590 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nasya procedure in Watering of Nose Sneezing and Nasal obstruction |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Kustadi Taila And Lakshadi Taila Nasya In Vataja Pratishyaya W.S.R Allergic Rhinitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka R Sudi |
| Designation |
Pg Scholor |
| Affiliation |
Shri Vijay Mahantesh Ayurvedic medical college Ilkal |
| Address |
Mahanta Gangotri Near Bus stand R P Karadi Ayurvedic Hospital Ilkal Karnataka India
Department Of Shalakya Tantra Ground floor Room No 2
Pin Code 587125
Mahanta Gangotri Near Bus stand R P Karadi Ayurvedic Hospital Ilkal Karnataka India
Department Of Shalakya Tantra Ground floor Room No 2
Pin Code 587125
Bagalkot
KARNATAKA
587125
India |
| Phone |
6360496741 |
| Fax |
00000 |
| Email |
priyankasudi77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Jadhav |
| Designation |
BAMS Ms (Ayu) (Ph D) |
| Affiliation |
Shri Vijay Mahantesh Ayurvedic Medical College |
| Address |
Mahanta Gangotri Near Bus stand R P Karadi Ayurvedic Hospital Ilkal Karnataka India
Department Of Shalakya Tantra Ground floor Room No 2
Pin Code 587125
Mahanta Gangotri Near Bus stand R P Karadi Ayurvedic Hospital Ilkal Karnataka India
Department Of Shalakya Tantra Ground floor Room No 2
Pin Code 587125
Bagalkot
KARNATAKA
587125
India |
| Phone |
7204343105 |
| Fax |
00000 |
| Email |
vinu2966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka R Sudi |
| Designation |
Pg scholor |
| Affiliation |
Shri Vijay Mahantesh Ayurvedic medical college Ilkal |
| Address |
Mahanta Gangotri Near Bus stand R P Karadi Ayurvedic Hospital Ilkal Karnataka India
Department Of Shalakya Tantra Ground floor Room No 2
Pin Code 587125
Mahanta Gangotri Near Bus stand R P Karadi Ayurvedic Hospital Ilkal Karnataka India
Department Of Shalakya Tantra Ground floor Room No 2
Pin Code 587125
Bagalkot
KARNATAKA
587125
India |
| Phone |
6360496741 |
| Fax |
00000 |
| Email |
priyankasudi77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Vijay Mahantesh Ayurvedic Medical College and Research Center R P Karadi Ayurvedic Hospital
Ilkal Taluk Bagalkot District Karnataka State India Country
Pincode 587125 |
|
|
Primary Sponsor
|
| Name |
SHRI VIJAY MAHANTESH AYURVEDIC MEDICAL COLLEGE ILKAL BAGALKOT KARNATAKA |
| Address |
Shri Vijay Mahantesh Ayurvedic college and Research center Taluk-Ilkal District-Bagalkot State-Karnataka Country-India Pin Code-587125 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priyanka R Sudi |
Shri Vijay Mahantesh Ayurvedic Medical College Ilkal 587125 |
Mahanta Gangotri Campus Department Of ENT Ground Floor Room no 2 Ilkal Taluk Bagalkot District Karnataka state Pincode 587125
Bagalkot
KARNATAKA |
6360496741
00000
priyankasudi77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Vijay mahantesh Ayurvedic Medical College Ilkal 587125 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism. Ayurveda Condition: VATAJAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Sharandhar Madyam khand , Procedure details: Patient is instilled with trial medicine into the nostrils and aked to spit if reaches throat )
(1) Medicine Name: Kushtadi Taila , Reference: Sharandhar Madyam khand , Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days(2) Medicine Name: Lakshadi Taila , Reference: Sharandhar Madyam khand , Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Who Are Fit For Nasya Karma Will Be Selected.
2.Patients Between The Age Groups Of 18 to 60 Years of Either Sex
3.The Cases of Vataja Pratisyaya Presenting With Signs And Symptoms As Per Classics are Included |
|
| ExclusionCriteria |
| Details |
1.Patient Who Are Contraindicated For Nasya Karma Are Excluded.
2.Patient With Nasal Polyp, DNS, Sinusities, Tumors Are Excluded.
3.Patient with other Systemic Disorders.
4.Suffering from Any Infectious Disease of Nose And Endocranial Disorders Are Excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced symptoms of Running nose Nasal obstruction Sneezing |
22 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced All symptoms of Running nose Nasal obstruction and Sneezing |
22 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
|
N/A |
|
Date of First Enrollment (India)
|
29/08/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The Prevalence Of Allergic Rhinitis Is Approximately 20% Of Population In India Treatment Nasya karma for 7 days is undertaken and First Follow up on 15th day And 2nd Follow up on 22nd day Thus Ensuring its Beneficiency an Attempt is Made Through Comparative Study of Kustadi and Lakshadi Taila in Vataja Pratishyaya Aiming to Improve their Quality of life Hence the study taken and entitled as A Comparative Clinical Study To Evaluate The Efficacy Of Kustadi Taila Nasya and Lakshadi Taila Nasya In Vataja Pratishyaya W S R Allergic Rhinitis
|