| CTRI Number |
CTRI/2025/07/090643 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Kadali vs Apamarga Kshar Therapy in Nasal Blockage Due to Turbinate Swelling |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Kadali Kshara Pratisarana Nasya versus Apamarga Kshara Pratisarana in the management of Nasapratinaha Inferior Turbinate Hypertrophy Randomized Controlled Trial |
| 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 Gauri Ghate |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved college and research center salod Hirapur Wardha |
| Address |
Room No 24 Shalakyatanta OPD Mahatma Gandhi Ayurved college and research center salod Hirapur Wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7385373978 |
| Fax |
|
| Email |
gaurighate2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Borghare |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved college and research center salod Hirapur Wardha |
| Address |
Room No 24 Shalakyatanta OPD Mahatma Gandhi Ayurved college and research center salod Hirapur Wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9881225532 |
| Fax |
|
| Email |
drpramodborghare@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Borghare |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved college and research center salod Hirapur Wardha |
| Address |
Room No 24 Shalakyatanta OPD Mahatma Gandhi Ayurved college and research center salod Hirapur Wardha Maharashtra India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9881225532 |
| Fax |
|
| Email |
drpramodborghare@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Maharashtra
442001
India |
|
|
Primary Sponsor
|
| Name |
Dr Gauri Ghate |
| Address |
Room No 24 Shalakyatanta OPD Mahatma Gandhi Ayurved college and research center salod Hirapur Wardha Maharashtra India 442001 |
| 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 Gauri Ghate |
Mahatma Gandhi Ayurved College Hospital and Research Center |
Room No 24 Shalakyatantra OPD Salod Hirapur Wardha Maharashtra India 442001
Wardha
MAHARASHTRA |
7385373978
gaurighate2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Kadali, Reference: NA, Route: Topical, Dosage Form: Kshara, Dose: 3(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Kadali Kshar will be applied locally on inferior turbinate alternate days | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Apamarga, Reference: NA, Route: Topical, Dosage Form: Kshara, Dose: 3(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Apamarga Kshara applied locally on Inferior turbinate hypertrophy alternate days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient having Nasapratinaha(ITH) will be randomly select.
Patients above 20 to 80 years of age will be selected.
Selection is irrespective of gender, religion & socio economical class.
Subjects willing to participate in the study and sign the written informed consent.
|
|
| ExclusionCriteria |
| Details |
Bleeding Disorders (Raktapitta/Nosebleeds - Urdhva Raktapitta)
Atrophic Rhinitis (Pootinasa)
Nasal polyp
Allergic Rhinitis (Vata-Kapha Pratishyaya with hypersensitivity)
Nasal Septal Perforation/Ulcers (Nasa Pitta/Vrana).
Children & Very Elderly Patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce size of inferior turbinate hypertrophy |
6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Total nasal symptoms score |
6 Weeks |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
20/08/2025 |
| 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)
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gaurighate2@gmail.com].
- For how long will this data be available start date provided 01-09-2026 and end date provided 01-09-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study aims to evaluate and compare the efficacy of Kadali Kshara Pratisarana Nasya and Apamarga Kshara Pratisarana Nasya in managing Nasapratinaha Inferior Turbinated Hypertrophy. It is a randomized doubleblind clinical trial involving 76 patients. Both treatments are based on Ayurvedic Kshara Karma a minimally invasive alternative to surgery. Patients are assessed using TNSS DNE and X ray PNS. Kadali Kshara is hypothesized to be non-inferior to Apamarga Kshara with potentially better patient comfort. The study fills research gaps regarding comparative efficacy, standardization, and safety of these therapies.
|