CTRI/2025/05/087236Not yet recruitingPhase 2
A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF AAMRADIPALLAVA TAILA KARNAPICHU AND GUGGULUADI KARNA DHOOPANA WITH GANDHAKA RASAYANA IN KARNASRAVA W.S.R. TO CHRONIC SUPPURATIVE OTITIS MEDIA (CSOM)
National Institute Of AyurvedaJaipur1 site in 1 country20 target enrollmentStarted: July 25, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- -Changes in the karnasrava
Study Overview
Brief Summary
A RANDOMIZED COMPARATIVECLINICAL TRIAL TO EVALUATE THE EFFICACY OF AAMRADIPALLAVA TAILA KARNAPICHU ANDGUGGULUADI KARNA DHOOPANA WITH GANDHAKA RASAYANA IN KARNASRAVAW.S.R. TO CHRONIC SUPPURATIVE OTITIS MEDIA (CSOM)
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients fulfilling the diagnostic criteria which are based on sign and symptoms of Karnasrava as well as CSOM -like -Ear discharge (active /inactive) -hearing loss -perforation (tubotympanic perforation ) 2.Patient comes with other associated symptoms along with ear discharge and perforation like –Karnakandu (Ear itching),karnanadha (Tinnitus), karnasula.
Exclusion Criteria
- •Patients aged below 18 and above 60 years will be excluded.
- •2.Patients having atticoantral type of CSOM 3.Total perforation and traumatic perforation of tympanic membrane.
- •4.Patients suffering from any chronic debilitating disease and cases which required surgical intervention will be excluded from study.
- •5.Pregnant and lactating women 6.Patient with having malignant otitis externa 7.CSOM with complication like – acute mastoiditis, Petrositis, facial paralysis, adenoids, tonsillitis, labyrinthitis etc.
Outcomes
Primary Outcomes
-Changes in the karnasrava
Time Frame: after completion of 1 month of therapy
Secondary Outcomes
- changes in the assessment scoring / grading(after completion of 1 month of therapy)
Investigators
Study Sites (1)
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