CTRI

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CTRI Number

CTRI/2026/01/102594 [Registered on: 30/01/2026] Trial Registered Prospectively

Last Modified On:

30/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

A Study to assess the benefit of Ear washing and medicated Ear Oil Treatment in patients suffering from Chronic Ear Discharge.

Scientific Title of Study

A Clinical study on Curative effect of Karnaprakshalan with Panchvalkaladi Kwath and Kshara Taila Karna Pichu in Karnasrava with special reference to Chronic Suppurative Oitis Media.

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 Sunder Singh
Designation	PG Scholar
Affiliation	Government Ayurvedic College and Hospital,Kadamkuan,Patna
Address	Department of Shalakya Tantra Government Ayurvedic College and Hospital,Kadamkuan Patna BIHAR 800003 Patna BIHAR 800003 India
Phone	9877744283
Fax
Email	DRSUNDERSINGHMS@GMAIL.COM

Details of Contact Person
Scientific Query

Name	Dr prof Kumari Uma Pandey
Designation	Professor and Head of Department
Affiliation	Government Ayurvedic College and Hospital,Kadamkuan,Patna
Address	Department of Shalakya Tantra Government Ayurvedic College and Hospital,Kadamkuan Patna BIHAR 800003 Patna BIHAR 800003 India
Phone	9431646285
Fax
Email	umapandey.nipun@gmail.com

Details of Contact Person
Public Query

Name	Dr prof Kumari Uma Pandey
Designation	Professor and Head of Department
Affiliation	Government Ayurvedic College and Hospital,Kadamkuan,Patna
Address	Department of Shalakya Tantra Government Ayurvedic College and Hospital,Kadamkuan Patna BIHAR 800003 Patna BIHAR 800003 India
Phone	9431646285
Fax
Email	umapandey.nipun@gmail.com

Source of Monetary or Material Support

Government Ayurvedic Medical College and Hospital,Kadamkuan,Patna,Bihar 800003,India

Primary Sponsor

Name	Government Ayurvedic College and Hospital KadamkuanPatna
Address	Department of Shalakya Tantra, Government Ayurvedic College and Hospital,Kadamkuan,Patna,BIHAR,INDIA
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sunder Singh	Government Ayurvedic College and Hospital,Patna	ROOM NO3,Shalakya Tantra OPD ,Patna BIHAR Patna BIHAR	9877744283 DRSUNDERSINGHMS@GMAIL.COM

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Government Ayurvedic College and Hospital,Patna	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:H661\|\|Chronic tubotympanic suppurative otitis media. Ayurveda Condition: KARNA-SRAVAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Panchvalkaladi Kwath, Reference: Sushruta Samhita Chapter no 21 Verse 42 , Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: This Kwath is used for Karnaprakshalan(Ear Cleansing ) After that moping with dry cotton karna pichu(cotton wicks) is done with Kshara Taila for Same 15 Days
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Kshara Taila , Reference: Charaka Samhita Chapter no 26 verse 216-220 , Route: Topical, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: This Medicated Ear oil is Mentioned in Charaka Samhita i used this oil in the form of cotton wicks(karna pichu) after ear cleansing with panvalkaladi kwath

Inclusion Criteria

Age From	10.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients full fill following condition will be Enrolled in the Trials 1)The patients having age between 10 to 70 years. 2)The patient having clinical sign and symtoms of karnasrava i.e CSOM irrespective of sex and socio-ecnomical status.

ExclusionCriteria

Details

Patients have following condition will not be Enrolled in the Trials
1)Age above 70 and less than 10 years.
2)Immunocompromised patients e.g. HIV,DM,TB etc.
3)Severe deformities of external and middle ear with severe SNHL.
4)Known cases of vertigo.
5)Patient with subtotal perforation or perforation with destruction of annulus tympani.
6)Patient with ear polyp ,marginal perforation and intra temporal and intra cranial complication.
7)Patient with atticoantral CSOM(unsafe/dangerous type).

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To Determine the Mean change in size of Tympanic Membrane Perforation	day7, day14, day 21, day28

Secondary Outcome

Outcome	TimePoints
1)To determine the Mean change in Conductive deafness With The help of Pure Tone Audiometry. 2)To determine the mean change in Otological Sign and symptoms like change in amount of otorrhea 3)To Study the Effect of Most Ayurvedic Medicine kshara Taila in Karnasrava.	day1,day28

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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)

10/02/2026

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="0"
Months="4"
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

Introduction Chronic Suppurative Otitis Media (CSOM) is a common chronic ear disease characterized by persistent ear discharge through a perforated tympanic membrane, often leading to hearing impairment and reduced quality of life. In Ayurveda, a similar condition is described as Karnasrava, which is mentioned in classical texts such as Sushruta Samhita and Charaka Samhita.

PurposeThe present study is planned to evaluate the curative and symptomatic effects of Karnaprakshalana with Panchvalkaladi Kwath followed by Karna Pichu with Kshara Taila in patients suffering from Karnasrava with special reference to CSOM. Panchvalkaladi Kwath possesses cleansing, anti-inflammatory, and wound-healing properties, while Kshara Taila is traditionally indicated in chronic ear diseases due to its antimicrobial and healing actions.

This is an open-label, randomized, single-group clinical study in which 30 clinically diagnosed patients of Karnasrava (CSOM) aged between 10 and 70 years will be selected from the OPD and IPD of the Department of Shalakya Tantra, Government Ayurvedic College and Hospital, Patna. Karnaprakshalana will be performed using Panchvalkaladi Kwath, followed by Karna Pichu with Kshara Taila for a treatment duration of 30 days, with follow-up up to 2 months.

Main outcome measures Assessment will be done based on changes in ear discharge, size of tympanic membrane perforation, and hearing status, evaluated clinically, otoscopically, and audiometrically. The study aims to establish the therapeutic efficacy of these Ayurvedic procedures and to provide a safe, cost-effective alternative for the management of CSOM, thereby helping in early prevention of hearing loss.