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Clinical Trials/CTRI/2025/03/083097
CTRI/2025/03/083097Not yet recruitingPhase 2/3

Efficacy of Bilwadi Taila Karnapurana and Sarivadi Vati with and without Shadabindu Taila Nasya in the management of Badhirya (Sensory Neural Hearing Loss)

Institute of Teaching and Research in Ayurveda, Jamnagar1 site in 1 country30 target enrollmentStarted: May 1, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Efficacy of intervention on signs and symptoms of Badhirya (Sensory Neural Hearing Loss) and reduction in the subjective criteria assessed.

Study Overview

Brief Summary

This trial is randomized clinical trial to evaluate Efficacy of Bilwadi Taila Karnapurana and Sarivadi Vati with and without Shadabindu Taila Nasya in the management of Badhirya (Sensory Neural Hearing Loss). Total 30 patients will be divided into two groups on the basis of computer-based randomization. In the study Bilwadi Taila Karnapurana 24-26 drops in each ear at evening time for 100 matra, Sarivadi Vati orally, 2 Vati (each Vati 250mg) thrice a day with lukewarm water after meal and Shadabindu Taila Nasya (6-6 drops in each nostril) at morning will be done in one group (group-A). In other group (group-B) only Bilwadi Taila Karnapurana and Sarivadi Vati is given without Shadabindu Taila Nasya for 1 month duration. Follow up will be carried out at 15 days interval for one month after completion of therapy.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patient between the age of Eighteen to Sixty year.
  • 2.Degree of Hearing Loss (Between 25dB to 90dB Sensory Neural Hearing Loss).

Exclusion Criteria

  • Patient below Eighteen years and above Sixty years of age.
  • Degree of Hearing Loss greater than 90dB.
  • Conductive hearing loss
  • Mixed hearing loss
  • Inner ear pathology like Acoustic Neuroma, Menieres disease.
  • Genetic Sensory Neural Hearing Loss
  • Psycogenic hearing loss
  • Systemic diseases: Diabetes, Hypothyroidism, Renal disorders, Autoimmune disorders, Multiple sclerosis.
  • Malignancy
  • Pregnant women
  • Patient taking any systemic drugs which can alter the result of study
  • Patients who need surgical intervention.

Outcomes

Primary Outcomes

Efficacy of intervention on signs and symptoms of Badhirya (Sensory Neural Hearing Loss) and reduction in the subjective criteria assessed.

Time Frame: 30 days (4 weeks)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Institute of Teaching and Research in Ayurveda, Jamnagar
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Radhika

Institute of Teaching and Research in Ayurveda, Jamnagar, Gujrat

Study Sites (1)

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