| CTRI Number |
CTRI/2025/06/088273 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of Shigru taila and Kalingadi taila nasa pichu(nasal pack) in the management of Apeenasa w.s.r to Chronic simple rhinitis
|
|
Scientific Title of Study
|
An open label double arm randomized comparative clinical study to evaluate the efficacy of Shigru taila and Kalingadi taila nasapichu in the management of Apeenasa wsr to Chronic simple rhinitis
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S A Srivatsa Kumar |
| Designation |
Pg Scholar |
| Affiliation |
Sri Kalabyreshwara Swamy Ayurvedic Medical College Hospital & Research Centre Bangalore |
| Address |
Department Of Shalakya Tantra Room Number 21 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And
Research Centre
No 10 Pipeline Road RPC Layout
Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
8892233125 |
| Fax |
|
| Email |
srivatsakumar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hamsaveni V |
| Designation |
Professor |
| Affiliation |
Sri Kalabyreshwara Swamy Ayurvedic Medical College Hospital & Research Centre Bangalore |
| Address |
Department Of Shalakya Tantra Room Number 21 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And
Research Centre
No 10 Pipeline Road RPC Layout
Vijayanagar Bangalore 560104
Department Of Shalakya Tantra Room Number 21 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And
Research Centre
No 10 Pipeline Road RPC Layout
Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9900110912 |
| Fax |
|
| Email |
vimalbut@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hamsaveni V |
| Designation |
Professor |
| Affiliation |
Sri Kalabyreshwara Swamy Ayurvedic Medical College Hospital & Research Centre Bangalore |
| Address |
Department Of Shalakya Tantra Room Number 21 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And
Research Centre
No 10 Pipeline Road RPC Layout
Vijayanagar Bangalore 560104
Department Of Shalakya Tantra Room Number 21 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And
Research Centre
No 10 Pipeline Road RPC Layout
Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9900110912 |
| Fax |
|
| Email |
vimalbut@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Kalabyraweshwara swamy ayurveda medical college hospital and research center
No 10 pipeline road, rpc layout,vijayanagar,bangalore 560104 |
|
|
Primary Sponsor
|
| Name |
Dr S A Srivatsa Kumar |
| Address |
Department Of Shalakya Tantra Room Number 21 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And
Research Centre
No 10 Pipeline Road RPC Layout
Vijayanagar Bangalore 560104
|
| 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 Kiran M Goud |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre |
Department Of Shalakya Tantra Room Number 21 Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And
Research Centre
No 10 Pipeline Road RPC Layout
Vijayanagar Bangalore 560104
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:J310||Chronic rhinitis. Ayurveda Condition: APINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | picu, पिचु | (Procedure Reference: caraka samhita , chapter 11,sloka 55, Procedure details: Poorvakarma
Patient Is Made To Lie In Supine Position
Sambara Sangraha
Sterile Pichu Is Made With Cotton Gauze & Is Soaked In The Lukewarm Medicine
Pradhana Karma
Sterile Pichu Is Gently Inserted Into The Nasal Cavity & Is Retained For 20 Minutes The Procedure Is Then Repeated For Another Nasal Cavity
Paschat Karma
After The Removal Of Pichu Patient Is Given Steam Inhalation)
(1) Medicine Name: kalingadi taila, Reference: chakradatta ,chapter 58 ,sloka 7 and 8, Route: Nasal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 10 Days | | 2 | Intervention Arm | Procedure | - | picu, पिचु | (Procedure Reference: caraka samhita , chapter 11,sloka 55, Procedure details: Poorvakarma
Patient Is Made To Lie In Supine Position
Sambara Sangraha
Sterile Pichu Is Made With Cotton Gauze & Is Soaked In The Lukewarm Medicine
Pradhana Karma
Sterile Pichu Is Gently Inserted Into The Nasal Cavity & Is Retained For 20 Minutes The Procedure Is Then Repeated For Another Nasal Cavity
Paschat Karma
After The Removal Of Pichu Patient Is Given Steam Inhalation)
(1) Medicine Name: shigru taila, Reference: vangasena samhita ,chapter 3 5 ,sloka 102, Route: Nasal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with lakshanas of Apeenasa
Subjects with signs and symptoms of Chronic Simple Rhinitis
Subjects of either gender
|
|
| ExclusionCriteria |
| Details |
Subjects with atrophic rhinitis, nasal polyps, epistaxis,Benign and malignant nasal and paranasal tumours.
Pregnant and lactating mother.
Subjects presenting with major systemic diseases that may interfere with the course of treatment.
|
|
|
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 |
Shigru taila is more beneficial than Kalingadi taila in the management of Apeenasa
|
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
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)
|
20/06/2025 |
| 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="1"
Days="5" |
|
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
|
A pilot study was conducted on 10 cases of Apeenasa w.s.r.to Chronic Simple Rhinitis using Kalingadi
taila Nasa Pichu dharana for 20 minutes.As the results
were very much encouraging in terms of reducing the signs and symptoms of
Chronic Simple Rhinitis , including
reduction in the size of turbinates .The present study is being undertaken
using Shigru taila and Kalingadi taila to validate the comparative efficacy of both the medicines in
the management of Apeenasa w.s.r to Chronic Simple Rhinitis |