| CTRI Number |
CTRI/2025/12/099073 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Application of drug] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of Palasha kshara application over Inferior turbinate hypertrophy over 100 participants and the effect is noted compared to a standard group |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to evaluate the efficacy of Palasha Kshara Pratisarana in Nasanaha ( Grade 3 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 Sharada Madiwalar |
| Designation |
Associate professor |
| Affiliation |
Shri Jagadguru Gavisiddeshwara Ayurveda Medical College and Hospital |
| Address |
Shri Kalidas Ayurvedic Medical College and Hospital Badami 587201
Sharada Hospital
Gudneppamath road
Near tippu sultan circle
Kukanuru Koppal 583232
Koppal
KARNATAKA
587201
India |
| Phone |
8971170703 |
| Fax |
|
| Email |
shardamadiwalar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharada Madiwalar |
| Designation |
Associate professor |
| Affiliation |
Shri Jagadguru Gavisiddeshwara Ayurveda Medical College and Hospital |
| Address |
Shri Kalidas Ayurvedic Medical College and Hospital Badami 587201
Sharada Hospital
Gudneppamath road
Near tippu sultan circle
Kukanuru Koppal 583232
Koppal
KARNATAKA
587201
India |
| Phone |
8971170703 |
| Fax |
|
| Email |
shardamadiwalar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharada Madiwalar |
| Designation |
Associate professor |
| Affiliation |
Shri Jagadguru Gavisiddeshwara Ayurveda Medical College and Hospital |
| Address |
Shri Kalidas Ayurvedic Medical College and Hospital Badami 587201
Sharada Hospital
Gudneppamath road
Near tippu sultan circle
Kukanuru Koppal 583232
Koppal
KARNATAKA
587201
India |
| Phone |
8971170703 |
| Fax |
|
| Email |
shardamadiwalar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal
583231 KARNATAKA INDIA |
| Shri Kalidas Ayurvedic Medical College and Hospital Badami 587201 KARNATAKA INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Sharada Madiwalar |
| Address |
Associate professor Shalakya tantra department
Shri Kalidas Ayurvedic Medical College and Hospital Badami 587201 KARNATAKA INDIA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Veerayya R Hiremath |
Shri Jagadguru gavisiddeshwara Ayurvedic Medical College and Hospital |
Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal 583231
Koppal
KARNATAKA |
9448544376
drvrh.aug15@gmail.com |
| Dr Sharada Madiwalar |
Shri Kalidas Ayurvedic Medical College and Hospital |
Shri Kalidas Ayurvedic Medical College and Hospital Badami 587201
Sharada Hospital
Gudneppamath road
Near tippu sultan circle
Kukanuru Koppal 583232
Bagalkot
KARNATAKA |
08971170703
shardamadiwalar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SJGAMC&HK 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 | Comparator Arm | Procedure | - | vraNasyaShaShTi-upakrapratisAraNa-karma, प्रतिसारण-कर्म | (Procedure Reference: Sushruta Samhita, Procedure details: Apamarga Kshara Pratisarana on 1st day and 7th day over Nasanaha till jambuphalavat varna appears followed by lemon juice application)
(1) Medicine Name: Apamarga kshara, Reference: Astanga Hridaya, Route: Topical, Dosage Form: Kshara, Dose: 1(NA), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Procedure | - | pratisAraNa-karma, प्रतिसारण-कर्म | (Procedure Reference: Sushruta Samhita, Procedure details: Palasha Kshara Pratisarana on 1st and 7th day over nasanaha till jambuphalavat varna appears followed by lemon juice application)
(1) Medicine Name: Palasha Kshara, Reference: Astanga Hridaya, Route: Topical, Dosage Form: Kshara, Dose: 1(NA), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects showing symptoms of hypertrophied turbinate like nasal obstruction, difficulty breathing, nasal discharge, headache and sleep apnea
2.Subjects who are willing for the study |
|
| ExclusionCriteria |
| Details |
1.Subjects with Chronic systemic disorders like cardiac, renal, cerebral disorders and known case of diabetes mellitus
2.Subjects with thick nasal discharge, vestibulitis, DNS, Nasal polyp and any other inflammatory conditions in and around the nose |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Palasha Kshara pratisarana is more effective than apamarga kshara pratisarana in Nasanaha |
5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/01/2027 |
| 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="5"
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 - NO
|
|
Brief Summary
|
The study is to evaluate the efficacy of Palasha Kshara Pratisarana in Grade 3 turbinate hypertrophy which is compared with the control group of Apamarga Kshara Pratisarana which is already been proved to be having good result in turbinate hypertrophy. This study is to evaluate whether the Palasha kshara pratisarana is more effective than the Apamarga kshara pratisarana in Grade 3 inferior turbinate hypertrophy. |