To Study the Effect of Karnapurana in the Patient of Tinnitus

Phase 2/3

Recruiting

• Conditions: Noise effects on inner ear. Ayurveda Condition: KARNA-NADAH,

• Registration Number: CTRI/2025/04/085979
• Lead Sponsor: Parul Institute Of Ayurveda And Research

Brief Summary

This study aims to compare the therapeutic effects of Karnapurana with Lashun Siddha Moorchit Sarshap Tail and Moorchit Sarshap Tail in the treatment of Karnanada (tinnitus). It is a randomized controlled trial involving adults with moderate to severe subjective tinnitus. The primary outcome will be the reduction in tinnitus severity, assessed using the Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI). Secondary outcomes include quality of life, sleep quality, anxiety and depression levels, and safety monitoring. Follow-up evaluations will assess both the efficacy and safety of the treatments.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-06
• Last Update Posted: 2025-10-04

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adults aged 18-75 years.
• Clinical diagnosis of subjective tinnitus.
• Participants with moderate to severe tinnitus as assessed by a validated tinnitus severity scale (Tinnitus Handicap Inventory, Tinnitus Functional Index).
• Stable general health with no acute systemic illness or active ear infections.
• Absence of prior ear surgery or invasive procedures affecting auditory function.
• Absence of known allergy to garlic or mustard to ensure safety of oil application.
• Willing and able to comply with study procedures and follow-up visits.

Exclusion Criteria

• Objective tinnitus or structural auditory abnormalities.
• Severe otological or neurological disorders.
• Significant psychiatric disorders.
• Pregnancy or lactation.
• Ear infections or inflammation.
• Allergies to intervention.
• Tinnitus from earwax, foreign bodies, or tympanic membrane rupture.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduces the severity of tinnitus.	0-15 days | BT-0th Day | DT-7th Day | AT-15th Day

Secondary Outcome Measures

Name	Time	Method
Improvement in Tinnitus Severity (Subjective Perception),Quality of Life,Changes in Sleep Quality,Reduction in Anxiety and Depression Symptoms,Etc.	0-15 days

Trial Locations

Locations (1)

KHEMDAS HOSPITAL; 🇮🇳 Vadodara, GUJARAT, India

KHEMDAS HOSPITAL

🇮🇳Vadodara, GUJARAT, India

Dr Harshal Patil

Principal investigator

7020555354

dr.harshalgurjar@gmail.com