CTRI

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CTRI Number

CTRI/2023/06/054025 [Registered on: 16/06/2023] Trial Registered Prospectively

Last Modified On:

26/05/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

An ayurvedic treatment for Ear Discharge

Scientific Title of Study

Efficacy of an Ayurvedic Intervention on Chronic Suppurative Otitis Media

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	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
Phone	08722196150
Fax
Email	dr.akshatanara3389@gmail.com

Details of Contact Person
Scientific Query

Name	Prof Manoj Kumar
Designation	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
Phone	9793127744
Fax
Email	mkumarbhu@gmail.com

Details of Contact Person
Public Query

Name	Prof Manoj Kumar
Designation	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
Phone	9793127744
Fax
Email	mkumarbhu@gmail.com

Source of Monetary or Material Support

Institute of Medical Sciences Banaras Hindu University

Primary Sponsor

Name	Banaras Hindu University
Address	Department of Shalakya Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University VARANASI, Uttar Pradesh, India
Type of Sponsor	Research institution and hospital

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
Akshata Nara	Sir Sunderlal Hospital	Shalakya Tantra OPD Room No 13 Sir Sunderlal Hospital Institute of Medical Science, Banaras Hindu University Varanasi UTTAR PRADESH	08722196150 - dr.akshatanara3389@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute Ethics Committee	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: Sarivadi Vati, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -With this oral drug Karna dhupana(sushruta samhita) is done with karna dhupana yoga(sushruta samhita), 5-10 gm yogais taken for Karna dhupana is done for 5-7 minutes for 7 days
2	Comparator Arm (Non Ayurveda)		-	AuralToileting	aural toileting with vinegar (1ml) and normal saline(1ml) for 5 days , local antibiotic ciprofloxacin 2 drops bd for 5 days.

Inclusion Criteria

Age From	10.00 Year(s)
Age To	40.00 Year(s)
Gender	Both
Details	Patients Suffering from Safe or Tubo-Tympanic Chronic Suppurative Otitis Media without complications Chronicity of the CSOM more than 3 months Patients ready to sign informed consent form

ExclusionCriteria

Details

Patients Suffering from Unsafe or Attico-antral Chronic Suppurative Otitis Media
Chronicity of CSOM less than 3 months
CSOM with systemic complications
CSOM with serosanguinous discharge
CSOM with Sensori-nueral and mixed hearing loss

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Discharge quality and quantity	Day 0,Day7, Day15,Day30, Day45, Day 60

Secondary Outcome

Outcome	TimePoints
Changes in Perforation of TM, Culture and Sensitivity and Pure Tone Audiometry	Day 0,Day 60

Target Sample Size

Total Sample Size="200"
Sample Size from India="200"
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)

30/06/2023

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

None yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The patient diagnosed with Chronic suppurative otitis media fulfilling inclusion and exclusion criteria attending OPD Shalakya tantra and ENT OPD, S.S.Hospital ,IMS, BHU will be assigned into study group and trial group stratified block randomised 6 patient in 1 block with strata of discharge mild, moderate and severe.Each group comprises 100 patients. Study group will receive Sarivadi vati (500mg) 2 tablet bd,after food upto 1 month and dry mopping and Karnadhoopana yoga 5-10 gm for 7 days and control group will receive aural toileting with vinegar (1ml) and normal saline(1ml) for 5 days , local antibiotic ciprofloxacin 2 drops bd for 5 days. The study will be interventional, comparative RCT. The patients will be assessed based on subjective and objective parameters and follow up for consecutive 2 months in an interval of one month. Subjective parameters will be assessed according to scores -Otorrhea/Ear discharge -quality/quantity, Hearing loss,Tinnitus, Just before commencing treatment, after treatment and during follow up. Objective parameters include Perforation of Tympanic membrane, Pure Tone Audiometry and culture sensitivity test, assessed on before treatment and after treatment. The data collected will be analysed statistically by using appropriate test.