An ayurvedic treatment for Ear Discharge

Phase 2/3

Not yet recruiting

Conditions: Chronic tubotympanic suppurative otitis media. Ayurveda Condition: KARNA-SRAVAH,

Registration Number: CTRI/2023/06/054025

Lead Sponsor: Banaras Hindu University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discharge quality and quantity	Day 0,Day7, Day15,Day30, Day45, Day 60

Secondary Outcome Measures

Name	Time	Method
Changes in Perforation of TM,	Culture and Sensitivity and

Trial Locations

Locations (1): Sir Sunderlal Hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
Sir Sunderlal Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Akshata Nara
Principal investigator
08722196150
dr.akshatanara3389@gmail.com