| CTRI Number |
CTRI/2025/05/086992 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare The Efficacy Of Application Of Moolaka Alkali And Apamarga Alkali In Inferior Turbinate Hypertrophy |
|
Scientific Title of Study
|
An Open Label Double Arm Randomised Clinical Study To Compare The Efficacy Of Moolaka Pratisaraneeya Kshara And Apamarga Pratisaraneeya Kshara In The Management Of Nasanaha Wsr To Inferior Turbinate Hypertrophy |
| 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 Bindushree S B |
| Designation |
Post Graduate Scholar |
| Affiliation |
shri kalabyraveshwaraswamy ayurvedic medical college and research center |
| Address |
Room no 21 Department Of Shalakya Tantra Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Center Bengaluru Karnataka India 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9900529987 |
| Fax |
|
| Email |
bindushreesb1720@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hamsaveni v |
| Designation |
Professor |
| Affiliation |
shri kalabyraveshwaraswamy ayurvedic medical college and research center |
| Address |
Room no 21 Department Of Shalakya Tantra Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Center Bengaluru Karnataka India 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 Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Center |
| Address |
Room no 21 Department Of Shalakya Tantra Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Center Bengaluru Karnataka India 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9900110912 |
| Fax |
|
| Email |
vimalbut@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 21 Department Of Shalakya Tantra Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Center Bengaluru Karnataka India 560104 |
|
|
Primary Sponsor
|
| Name |
Dr Bindushree s b |
| Address |
Room no 21 Department Of Shalakya Tantra Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Center Bengaluru Karnataka India 560104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
not applicable |
|
|
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 Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Center |
Room no 21 Department Of Shalakya Tantra Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital And Research Center Bengaluru Karnataka India 560104
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| shri kalabyraveshwaraswamy ayurvedic medical college and research center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J343||Hypertrophy of nasal turbinates. Ayurveda Condition: NASAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः | (Procedure Reference: Sushrutha samhitha, Procedure details: Application of Apamarga Kshara 2.5mg in Inferior Turbinate Hypertrophy)
(1) Medicine Name: Apamarga Kshara, Reference: Sushrutha Samhitha, Route: Topical, Dosage Form: Kshara, Dose: 2.5(mg), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Procedure | - | pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः | (Procedure Reference: Sushrutha samhitha, Procedure details: Application of Moolaka Kshara 2.5mg in Inferior Turbinate Hypertrophy)
(1) Medicine Name: Moolaka Kshara, Reference: Ayurveda sara sangraha, Route: Topical, Dosage Form: Kshara, Dose: 2.5(mg), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with lakshanas of Nasanaha
Subjects with inferior turbinate hypertrophy
Subjects of either gender between 20 to 60 years of age
Subjects fit for kshara karma
|
|
| ExclusionCriteria |
| Details |
Subjects with history of Atrophic rhinitis Nasal polyps Epistaxis and history of Benign and Malignant nasal and paranasal tumours
Pregnant and lactating mother
Subjects presenting with 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 |
| to check the reduction of size of inferior turbinate hypertrophy using compass caliper nose score and friedman grading system of inferior turbinate hyper trophy through anterior rhinoscopy and other parameters in two treatment modalities viz moolaka pratisaraneeya kshara ans apamarga pratisaraneeya kshara in nasanaha w s r to inferior turbinate hypertrophy |
11day of study 1 day application, 3rd and 7 th day follow up |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="7" |
|
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
|
The main aim of the study is to reduce the size of the hypertrophied
inferior turbinates which causes nasal obstruction breathing problems frequent infection Hence in the present study Kshara karma pratisarana is
selected in the management of Nasanaha w s r Inferior turbinate
hypertrophy |