Ayurvedic treatment protocol of Poothikarna along with Nirgundyadi thaila karnapoorana in Otomycosis

Phase 2/3

Not yet recruiting

Conditions: Other infective otitis externa,

Registration Number: CTRI/2019/09/021151

Lead Sponsor: Amrita School of Ayurveda

Brief Summary: **RATIONALE** Otomycosis also known asfungal otitis externa has typically been described as fungal infection of theexternal auditory canal. The prevalence of otomycosis has been reported to beas low as 9% in cases of otitis externa and as high as 30.4% in patients presentingwith symptoms of otitis or inflammatory conditions of the ear. Moreover itusually occurs most frequently in adults, and less in children. The most commonfungal agents causing otomycosis are Aspergillusniger (80% of case) and Candidaalbicans second common. Several factors have been reported predisposingotomycosis which include; bacterial infections, use of hearing aid or a hearingprosthesis, self inflicted trauma, swimming in contaminated pools, broadspectrum antibiotic therapy, steroids and cytostatic medication, neoplasia andimmune disorders .

**OBJECTIVE**:-The objective of this study isto test the effectiveness of classical ayurvedic treatment protocol ofputikarna along with Nirgundyadithailakarnapoorana in otomycosis.

STUDY DESIGN: Preand post test study of 30 patients who are fulfilling the inclusion criteriawill be selected for the present clinical study.

**Design of the study**

After kayasodhana, for first fivedays ear mopping with aragwadadhikasaya, karnadhoopana with gugguluvarthi.Madhupramarjana and pratimarshanasya with anutailawill be done twice daily. On 6th day post fungal culture will be done. If the culture report is negative from 7th day onwards karnapoorana with nirgundyadithaila asmentioned in classics will be done for a period of 7 days.

Aragwadadhikashaya and tablet willbe administered internally during the treatment course.

Follow-up - Aftercompletion of the treatment the patients will be advised to report to SalakyaOPD once in a month for a period of three months to assess the sustained effectof treatment.

**EXPECTEDCOST** â€“ 30000 to40000 INR

Statistical analysis will be done using paired t test

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients of age 18 to 50 years Satisfying the diagnostic criteria Either sex Patients fit for karnapoorana.

Exclusion Criteria

age not within agelimit of 18 to 50 years Patient suffering from any systemic diseases and receiving medication Patient contraindicated for karnapoorana Other types of ear infection apart from otomycosis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fungalmass culture of ear swab	Fungalmass culture of ear swab will be done before recruitment of patient for the study and after 5 th day of the study \| Aural endoscopic pictures after 5th day and 15 the day of study
Aural endoscopic pictures	Fungalmass culture of ear swab will be done before recruitment of patient for the study and after 5 th day of the study \| Aural endoscopic pictures after 5th day and 15 the day of study

Secondary Outcome Measures

Name	Time	Method
VAS scale for pruritis and ear ache Grading of ear blokage	15th day

Trial Locations

Locations (1): Amrita School of Ayurveda
🇮🇳
Kollam, KERALA, India
Amrita School of Ayurveda
🇮🇳Kollam, KERALA, India
Dr Aswathy Krishna S
Principal investigator
8129896236
aswathykrishna3891@gmail.com