| CTRI Number |
CTRI/2025/12/099917 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Kshara Pratisarana Karma] |
| Study Design |
Other |
|
Public Title of Study
|
SNUHI KSHARA PRATISARANA KARMA IN THE MANAGEMENT OF APEENASA - CHRONIC HYPERTROPHIC RHINITIS AN OPEN LABEL DOUBLE ARM CONTROL CLINICAL TRIAL |
|
Scientific Title of Study
|
A RANDOMISED OPEN LABEL DOUBLE ARM CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SNUHI KSHARA PRATISARANA KARMA IN THE MANAGEMENT OF APEENASA - CHRONIC HYPERTROPHIC RHINITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjai S Menon |
| Designation |
PG Scholar |
| Affiliation |
SDM INSTITUTE OF AYURVEDA AND HOSPITAL |
| Address |
Department of Shalakya Tantra SDM Institute of Ayurveda Hospital Anchepalya Kumbalgodu Post Bengaluru Karnataka
Department of Shalakya Tantra Anchepalya, Kumbalgodu Post
Bengaluru, Karnataka ,Pin: 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
8848700242 |
| Fax |
|
| Email |
drsanjaimenon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mamatha K V |
| Designation |
Professor and HOD |
| Affiliation |
SDM Institute of Ayurveda Hospital |
| Address |
Department of Shalakya Tantra OPD 16 SDM Institute of Ayurveda Hospital Anchepalya Kumbalgodu Post Bengaluru Karnataka
Department of Shalakya Tantra OPD 16
Bangalore
KARNATAKA
560074
India |
| Phone |
9845393236 |
| Fax |
|
| Email |
mamatha.sova@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDr Mamatha K V |
| Designation |
Professor and HOD |
| Affiliation |
SDM Institute of Ayurveda Hospital |
| Address |
Department of Shalakya Tantra OPD 16 SDM Institute of Ayurveda Hospital Anchepalya Kumbalgodu Post Bengaluru Karnataka
Department of Shalakya Tantra OPD 16
Bangalore
KARNATAKA
560074
India |
| Phone |
9845393236 |
| Fax |
|
| Email |
mamatha.sova@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Institute of Ayurveda and Hospital |
|
|
Primary Sponsor
|
| Name |
Sanjai S Menon |
| Address |
SDMIAH Anchepalya Kumbalgodu Post 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 |
| Sanjai S Menon |
SDM Institute of Ayurveda and Hospital |
Department of Shalakya Tantra OPD numbers 10,1116,22 SDMIAH Anchepalya, Kumbalgode Post BANGALORE
Bangalore
KARNATAKA |
8848700242
drsanjaimenon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SDMIAH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Snuhi kshara, Reference: Susrutha Samhitha, Route: Nasal, Dosage Form: Kshara , Dose: 0.5(mg), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Kshara Pratisarana karma | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Apamarga Kshara , Reference: Susrutha Samhitha , Route: Nasal, Dosage Form: Kshara , Dose: 0.5(mg), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Kshara Pratisarana Karma |
|
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Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Both |
| Details |
Patients presenting with lakshanas of Apeenasa Chronic hypertrophic rhinitis
Age 20-50 years
|
|
| ExclusionCriteria |
| Details |
Malignancy
Nasal Papilloma Nasal polyp
Congenital anomalies of Nose and Sinus
Subjects with gross Deviated Nasal Septum More than 150
Subjects with history of systemic illness that interferes the course of treatment |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the size of Hypertrophic turbinates after kshara pratisarana karma from the base score |
On first assessment day zero and second assessment day eight of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in symptoms of apeenasa from before & after treatment.
Changes in Nasal obstruction symptom evaluation (NOSE) scale from base score
Standardization of the instrument to measure hypertrophied turbinate
|
On first assessment day zero & second assessment day eight of the study |
|
|
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)
|
18/01/2026 |
| 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 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
|
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Brief Summary
|
This study is a randomized open label double arm controlled clinical trial designed to evaluate the efficacy of Snuhi Kshara Pratisarana Karma in the management of Apeenasa Chronic Hypertrophic Rhinitis in comparison with Apamarga Kshara Pratisarana which is taken as the control. Chronic hypertrophic rhinitis is a common cause of persistent nasal obstruction due to irreversible hypertrophy of the inferior turbinates, and in Ayurveda it closely correlates with Apeenasa characterized by features such as nasanaha nasa srava shirashula gurgura swasam and gandha ajnana. Classical Ayurvedic texts particularly Charaka and Sushruta Samhitas describe Kshara Pratisarana as an appropriate line of management in conditions involving adhimamsa hypertrophy especially in anatomically delicate areas like the nasal cavity.
The study includes 40 patients aged 20 to 50 years diagnosed with Apeenasa Chronic hypertrophic rhinitis who are randomly allocated into two groups of 20 each. Group A receives Apamarga Kshara Pratisarana while Group B receives Snuhi Kshara Pratisarana with 0.5 to 0.7 g of Kshara applied over the hypertrophied inferior turbinates until pakwa jambu phala varna is attained, followed by neutralization and post procedure care. The duration of the intervention is 8 days with assessments conducted before and after treatment. Outcome measures include subjective improvement in symptoms such as nasal obstruction headache abnormal respiratory sounds and olfactory disturbance as well as objective assessment of turbinate size using anterior rhinoscopy photographic documentation a modified Castroviejo caliper and the Nasal Obstruction Symptom Evaluation scale. Statistical analysis will be performed using appropriate parametric and non-parametric tests. The study aims to determine whether Snuhi Kshara Pratisarana is superior or comparable to Apamarga Kshara in reducing turbinate hypertrophy and alleviating symptoms thereby providing an effective minimally invasive Ayurvedic alternative to conventional medical and surgical management of chronic hypertrophic rhinitis.
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