A clinical trial to study the effect of new drug Hingwadi Taila in Karnashoola i.e. pain in ear.

Phase 2

Not yet recruiting

• Conditions: Other otitis externa,

• Registration Number: CTRI/2019/10/021649
• Lead Sponsor: Dhanshree Atmaram Pol

Brief Summary

This is a randomized, parallel-group, open-label, active-controlled trial for assessing the efficacy of Hingvadi taila karnapooran in karnshoola w.s.r. to diffuse otitis externa over another ayurvedic formulation shrungberadi taila in 60 patients, that will be conducted in one center in India. Patients irrespective of gender, occupation and economical class with the age ranging in between 18 to 60 will be selected for the trial by random allocation. Karnapoorana will be done daily for 15 days in which the assessment will be done on 5th,10th, 15thand 30thday of treatment.

The primary outcome measures will be; reduction of pain in ear at 15 days. Secondary outcomes will be; reduction in itching and burning sensation if any.

The conclusion will be drawn based on outcomes and result will be generated accordingly with the help of statistical findings

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-10-14
• Study Start: 2019-10-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient having sign and symptoms of Karnashoola.
• Unilateral of Bilateral diffuse otitis externa.
• Intact tympanic membrane.

Exclusion Criteria

• Patients having any other karnarogas like Karnaguthak,Karnastrav.
• Patient having any other ear diseases than Diffuse otitis externa.
• Patient having any systemic disease expect hypertension.
• Congenital anomalies of the ear.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reduction of pain in ear	30 days

Secondary Outcome Measures

Name	Time	Method
reduction of burning and itching sensation if any..	30 days

Trial Locations

Locations (1)

Yashwant Ayurvedic College PGT & RC; 🇮🇳 Kolhapur, MAHARASHTRA, India

Yashwant Ayurvedic College PGT & RC

🇮🇳Kolhapur, MAHARASHTRA, India

Dhanshree Atmaram Pol

Principal investigator

9960970421

dhanupol.dp@gmail.com