Tila Taila (sesame oil) in management of Impacted Ear Wax

Phase 2/3

Completed

• Conditions: Impacted cerumen. Ayurveda Condition: KARNA-GUTHAKAH,

• Registration Number: CTRI/2023/01/049156
• Lead Sponsor: Dr Rajeev T

Brief Summary

**NEED OF THE STUDY:**

*Karnagootha* is one among *Karnarogas.* It can be correlated with impacted earwax or Cerumen can lead to symptoms such as hearing loss, tinnitus, pain, itching and vertigo.

Cerumen or ear wax is a mixture of the glandular secretions from the lateral third of the ear canal and exfoliated squamous epithelium. It lubricates the ear canal, acts as a trap for dust, hair and insects. Normally cerumen is eliminated or expelled by self-cleansing mechanism which causes it to migrate out of the ear canal assisted by jaw movements.

*Taila prakledana* has been mentioned classically as the first stage of *Karnagootha Chikitsa*.*Tila taila* is the best choice of drug due to its *Vatakaphaharatva, Snigdha, Sukshma, Tikshna and Ushna* properties, which can help in *Kledana* and *Shodhana* of *Karnagootha.*

Very few studies have been done with respect to management of *Karnagootha* (impacted wax). Among them published researches are still minimum.

Hence, an effort has been made in this present single armed clinical study to evaluate the efficacy of *Tila taila* in the management of *Karnagootha.*

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-25
• Study Completion: 2023-06-28
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Subjects presenting with the classical features of Impacted ear wax.
• 2.Subjects within the age of 21 to 60 years irrespective of gender, occupation, religion, socio-economic status and duration of illness.
• 3.Subjects willing to sign informed consent.

Exclusion Criteria

1.Subjects suffering from Otitis externa 2.Subjects suffering from Otomycosis 3.Subjects suffering from CSOM and ASOM 4.Subjects suffering from Tympanic Membrane Perforation, 5.Any other Inflammation and space occupying lesions of EAC.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Parameters	•Before treatment -0th day | •After treatment – 6th day | •1st Follow up – 10th day | •2nd Follow up - 15th day
•Tuning fork test (Rinne’s test – 512Hz)	•Before treatment -0th day | •After treatment – 6th day | •1st Follow up – 10th day | •2nd Follow up - 15th day
•Aural Endoscope	•Before treatment -0th day | •After treatment – 6th day | •1st Follow up – 10th day | •2nd Follow up - 15th day

Secondary Outcome Measures

Name	Time	Method
•Ear pain	•Itching in the Ear

Trial Locations

Locations (1)

Sri Sri college of Ayurveda science and Research Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sri Sri college of Ayurveda science and Research Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Rajeev T

Principal investigator

7829086544

rajeevraj0842@gmail.com