Efficacy of an Ayurvedic Intervention on Chronic Suppurative Otitis Media
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Banaras Hindu University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Discharge quality and quantity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 10.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Discharge quality and quantity
Time Frame: Day 0,Day7, Day15,Day30, Day45, Day 60
Secondary Outcomes
- Changes in Perforation of TM,(Culture and Sensitivity and)