| CTRI Number |
CTRI/2025/04/085639 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An ayurvedic treatment for nasal block and discharge |
|
Scientific Title of Study
|
Pilot Study to Evaluate the Efficacy of Topical Application of
Kadali Kshara on 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 |
Deepak Kumar Verma |
| Designation |
Junior resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalakya Tantra Faculty of Ayurveda Dhanwantari
Bhawan, Institute of Medical Science, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8429569221 |
| Fax |
|
| Email |
dr.dkverma@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Akshata nara |
| Designation |
Assistant professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalakya Tantra Faculty of Ayurveda Dhanwantari
Bhawan, Institute of Medical Science, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08722196150 |
| Fax |
|
| Email |
akshatanara@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Kumar Verma |
| Designation |
Junior resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalakya Tantra Faculty of Ayurveda Dhanwantari
Bhawan, Institute of Medical Science, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8429569221 |
| Fax |
|
| Email |
dr.dkverma@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Department of Shalakya Tantra Faculty of Ayurveda Dhanwantari
Bhawan, Institute of Medical Science, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Deepak Kumar Verma |
S.S Hospital |
Department of Shalakya Tantra Faculty of Ayurveda Dhanwantari
Bhawan, Institute of Medical Science, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH |
08429569221
dr.dkverma@bhu.ac.in |
|
|
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 | Comparator Arm (Non Ayurveda) | | - | Nasal decongestant | Topical use of Nasal decongestant (Xylometazoline Oxymetazoline Hydrochloride Nasal
Solution IP on ITH for 5 days | | 2 | Intervention Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: CHARAK CHIKITSA 26/157, Procedure details: A. Purva Karma • All the aseptic precautions will be taken throughout the procedure. • Procedure will be done empty stomach. • Lignocaine × 4% spray will be sprayed into the nostril to anesthetize the turbinate in order to avoid sneezing reflex & sensitivity. • Patient will be made to sit in comfortable position with the head extended by placing a pillow under the shoulders to expose the nasal cavity properly. • A gauze piece soaked in Go ghrita will be placed into the septal side of nostrils nasal cavity away from the turbinate to avoid involvement of other normal structures. B. Pradhana karma • The nasal cavity will be exposed using Thudicum’s Nasal Speculum and a secretion over the turbinate will be wiped out using gauze piece. • 0.5 gm Kadali kshara will be applied over the medial surface of the exposed turbinate, by using the cotton rolled over Jobson aural probe. • Applied kshara will be kept for 1-2 min. After sometime, the color changed to reddish brown (Jambuphalavat, i.e. the fruit of Syzizium cumini Linn.). • The kshara will be then removed with cotton rolled with Jobson aural probe. • Lemon juice will be applied over the turbinate to neutralize the remaining kshara. • Go ghrita will be applied over the burnt wound to overcome daha (burning sensation) if required. C. Paschata karma • The patient will be advised to avoid exposure to air or breeze, dust, smoke, etc., The patient will be advised to take light diet. ))
(1) Medicine Name: KADALI KSHARA, Reference: Sushruta Samhita (Su. Ut 11/11-12), Route: Topical, Dosage Form: Kshara, Dose: 30(mg), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of Nasanaha.
Patients having ITH.
Friedman Grading System of Inferior Turbinate Hypertrophy.
Nasal endoscopic grading system of inferior turbinate hypertrophy.
Patients ready to sign informed consent form. |
|
| ExclusionCriteria |
| Details |
Cases complicated with Nasal Polyposis.
Deviated Nasal Septum with Concha bullosa.
Age group of below 18 year and above 60year of age.
Pansinusitis
Pregnancy or lactating women.
Patient who starts developing complications will be excluded from the study.
Patient not willing for the treatment.
Ongoing systemic infection.
Ear, Nose & Throat malignancy.
Congenital deformity.
Cases which required surgical intervention. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in NOSE score from baseline to 15th day.
2. Friedman Grading System of Inferior Turbinate Hypertrophy from baseline to 15th Day |
Day 0, Day 7, Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in inferior turbinate hypertrophy size. |
Day 0, Day 15 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
12/05/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The patient diagnosed with inferior turbinate hypertrophy fulfilling inclusion and exclusion criteria attending OPD Shalakya tantra and ENT OPD, S.S.Hospital ,IMS BHU will be assigned into control and trial group by simple randomization. Present pilot study sample size is 15 in trial group and 10 in control group. In the trial group, topical application of kadali kshara was done while in the control group nasal decongestants Xylometazoline oxymetazoline hydrochloride nasal solution was given for 5 days.The patient will be assessed based on subjective and objective parameters and follow up for 7th and 15th day. Subjective parameters will be assessed according to NOSE(Nasal obstruction symptom evaluation) scores - Nasal congestion or stuffiness, Nasal blockage or obstruction, trouble breathing my nose, Unable to get enough air through my nose during exercise or exertion, Trouble sleeping, just before commencing treatment , after treatment and during follow up. Objective parameters include Friedman grading system of inferior turbinate hypertrophy, Nasal endoscopic grading system of inferior turbinate hypertrophy, Laboratory test CBC and ESR and Pictorial presentation of inferior turbinate hypertrophy before treatment and after treatment, assessed on before and after treatment. The data collected will be analysed statistically by using appropriate test. |