A randomized controlled clinical trial on efficacy of topical clotrimazole vs. topical fluconazole vs. topical application of gentian violet in the treatment of otomycosis conducted in a tertiary health care centre

RESEARCH QUESTIONS

Which antifungal treatment is more efficacious among fluconazole, clotrimazole and topical gentian violet?

HYPOTHESIS

There is a significant difference in efficacy among fluconazole, clotrimazole and topical gentian violet.

There is no significant difference in efficacy among fluconazole, clotrimazole and topical gentian violet.

AIM

To compare efficacy of topical fluconazole, clotrimazole and topical gentian violet in the treatment of otomycosis.

METHODOLOGY

1. STUDY DESIGN: Randomized Clinical Trial
2. STUDY SITE: This study will be conducted on patients suffering from Otomycosis coming in the Out patient ENT department (OPD) , K J Sonaiya Medical college and Hospital
3. SAMPLE SIZE: 100
4. STUDY TIMELINE: 6 months

RESEARCH METHODOLOGY AND ETHICAL CONSIDERATIONS

1. Ethical considerations:

2. The study will be conducted after obtaining permission from the Institutional Ethics Committee(IEC)

3. All data collected will be strictly confidential and used for the purpose of this study as described below.

4. Written informed valid consent (in English/Hindi/Marathi) will be taken from the subjects before the recruitment of the subjects in this study.

5. Any deviation from the below given methods/procedure will be informed to the Institutional Ethics Committee and only after the IEC’s approval any changes will be made.

6. The Proforma for the written informed consent is given herewith.

7. Subject Population:

8. Patients diagnosed with Otomycosis in ENT Out Patient Department will be enrolled in this trial.

9. Selection criteria:

10. Male and Female patients above the age of 18 years diagnosed with Otomycosis

11. Patients willing to enrol for the trial meeting the above trial.

12. EXCLUSION CRITERIA:

13. Patients not willing to be a part of the study.

14. Patients age below 18 years.

15. Patients having perforated tympanic membrane in the otomycosis infected ear.

16. Patients suffering from Chronic suppurative otitis media(CSOM)/Operated for CSOM

17. Study procedure:

18. Enrolment of the patients who fulfil inclusion criteria in the study

19. Recording and documentation of mentioned data collection points as per proforma.

20. Follow up and review patients after 1 week and 2 weeks and check improvement in signs and symptoms.

21. Analysis and interpretation of the data collected.

Patients that present to tertiary health care centre with symptoms of ear pain, itching, discharge, reduced hearing, aural fullness, tinnitus will be asked detailed history and undergo an otoscopic examination. Otomycosis will be confirmed by distinctive otoscopic findings which include:

1. Grayish white mass similar to wet blotting paper.
2. Blackish/white spores in the external auditory canal.

All patients will undergo aural toileting in the OP department itself. Treatment option will be given by Random sampling method. Patients will be asked to pick up a chit among three chits each having name of one of the following drugs ie. Fluconazole, clotrimazole and topical application of gentian violet. Fluconazole and Clotrimazole ear drops will be given as 2 drops three times daily. Patients will be taught proper method of ear drops instillation and to avoid the aggravating factors like water/moisture exposure, use of ear buds, oil instillation. In Group 3 patients receiving topical Gentian violet, solution of Gentian Violet will be applied in the external auditory canal weekly once by the medical practitioner. Other medications including Antihistaminics, Analgesics and Anti-inflammatory drugs will be given as per individual case scenarios and symptoms. Patients will be followed up after 7 days and 14 days for assessing improvement in symptoms and signs for otomycosis.

6. Data collection and Analysis:

All data will be collected in google sheets and printed form in the form of a specific proforma for the study.

7. Appropriate statistical tests - Chi square test will be applied to analyse the data as necessary.