| CTRI Number |
CTRI/2025/03/082621 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of two nasal drops in two groups of patients with allergic rhinitis |
|
Scientific Title of Study
|
To compare the efficacy of Shigru taila nasya with Shadbindhu taila nasya in Vataja pratisyaya Nasal eosinophilia An open label double arm controlled 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 Sreerenjini S |
| Designation |
Postgraduate scholar Department of Shalakyatantra |
| Affiliation |
SDM Institue of Ayurveda and Hospital |
| Address |
SDM Institute of Ayurveda and Hospital Anchepalya Kumbalagodu Bengaluru
Department of PG studies in Shalakya tantra , SDM Institute of Ayurveda and Hospital Anchepalya Kumbalagodu Bengaluru , Post 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
8547883628 |
| Fax |
|
| Email |
sreerenjini5191@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha K V |
| Designation |
Professor and HOD |
| Affiliation |
SDM Institue of Ayurveda and Hospital |
| Address |
Professor and HOD Department of Shalakya tantra SDM Institute Of Ayurveda and Hospital Anchepalya Kumalagodu Bengaluru
Professor and HOD Department pg studies in Shalakya tantra SDM Institute Of Ayurveda and Hospital Anchepalya Kumalagodu Bengaluru Post 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9845393236 |
| Fax |
|
| Email |
mamatha.sova@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreerenjini S |
| Designation |
Postgraduate scholar |
| Affiliation |
SDM Institue of Ayurveda and Hospital |
| Address |
SDM Institute of Ayurveda and Hospital Anchepalya Kumbalagodu Bengaluru
Department of PG studies in Shalaya tantra SDM Institute of Ayurveda and Hospital Anchepalya Kumbalagodu Bengaluru Post 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
8547883628 |
| Fax |
|
| Email |
sreerenjini5191@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Institute of Ayurveda and Hospital Anchepalya Kumbalagodu Bengaluru 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Sreerenjini S |
| Address |
SDM Institute Of Ayurveda and Hospital Anchepalya Kumbalagiodu Bengaluru |
| 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 Sreerenjini S |
SDM Institute Of Ayurveda and Hospital |
SDM Institute of Ayurveda and Hospital Anchepalya Kumbalagodu Bengaluru
Bangalore Rural
KARNATAKA |
08547883628
sreerenjini5191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , SDM Ayurveda and Hospital , Bengaluru |
Approved |
| Institutional ethics committee , SDM Ayurveda and Hospital , Bengaluru |
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 | Drug | Classical | | (1) Medicine Name: Shigru taila, Reference: Vnagasenasanhitha , Chikitsasara samgraha , Chapter 70, Route: Nasal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -doing in Aparahna | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shadbindhu taila , Reference: Bhaishajya ratnavali , nasarogadhikara , chapter 65, Route: Nasal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -doing in Aparahna |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting lakshanas of Vataja Pratisyaya
2.Nasal eosinophilia confirmed through Nasal smear
3.Patient with chronicity less than 5years
4.Patients fit for Nasya karma |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from upper respiratory tract infections
2.Patients who have uncontrolled Diabetes mellitus and Hypertension
3.Patient having recent medical therapy for Eosinophilia
4.Patients having Migraine headaches , Gross DNS, Adenoditis and Tonsillitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Global improvement in the signs and symptoms of Vataja pratisyaya
Reduction of Eosinophil count in Nasal smear |
0th day ,8th day ,15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
sustained effectbof teratment in subjective parameters
Improvement in TNNS questionnaire
To develop easily approachable cost effeective treatment |
0th day ,8th day, 15th day |
sustained effect of treatment on subjective parameters
Improvement changes in TNNS questionnaire
To develop easily approachable cost effective treatment |
0th day ,8th day ,15th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="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
|
An Open label double arm controlled clinical study to compare the efficacy of Shigru taila nasya with Shadbindhu Taila nasya in the management of Vataja pratisyaya - Nasal eosinophilia , age group of 20-40 years for a period 7 days.During this time period , 40 participants will be recruited and devided in to two groups Group A ( Trial group ) and Group B ( Control group) ,20 participants each.
Group A (Trial group ) 6 bindhu of Shigru taila Nasya will be instill to the nose of participants for 7 days.
Group B ( Control group ) 6 bindhu of Shadbindhu Tilam will be instill to the nose of participants for 7 days.
Clinical assesment will be done for both subjective and objective criteria on 0th day , 8th day and follow up on !5th day.
Statistical analysis will be done through data obtained on 0th day (BT) and 8th day (AT).
|