A Randomised Open Label Comparative Clinical Study To Evaluate The Efficacy Of ASHWAGANDHA GHRITA Orally And KSHEERA BALA 101 TAILA NASYA In The Management Of BADHIRYA W.S.R TO Sensorineural hearing loss
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- improvement in hearing ability and it will be measured by pure tone audiometry
Study Overview
Brief Summary
Hearing loss is the second most common cause of disability in India , 63 million people suffer from the significant auditory loss and is more common in the age group of 40 - 60 years . The patient to Sensorineural Hearing Loss is managed by corticosteriods , hearing aids or cochlear implants , the above treatments help the patient to improve their conditions temporarily . In accordance to Hearing Loss , Badhirya has been mentioned in Ayurveda and the Chikitsa mentioned is Vataghna and Vata- kaphagna . Thus considering the above facts , the line of treatment i.e Rasayana and Nasya mentioned in Badhirya has been taken up for the study . Hence , Ksheerabala 101 Taila Nasya has been indicated which would pacify the aggrevated vata dosha and ashwagandha ghrita given orally has Rasayana properties .
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 40.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Subjects with Sensorineural Hearing Loss.
- •2.Subjects with Intact Ear Drum.
- •3.Subjects in the age group 40-60 years.
Exclusion Criteria
- •1Subjects associated with Tympanic Membrane Perforation.
- •2Subjects of Congenital Hearing Loss.
- •3Subjects with Conductive Hearing Loss and Mixed Hearing loss.
- •4Subjects with Otorrhoea.
- •5Subjects that are contra-indicated for Nasya.
Outcomes
Primary Outcomes
improvement in hearing ability and it will be measured by pure tone audiometry
Time Frame: 30 days
Secondary Outcomes
- improvement in hearing will be measured by NRS scale for deafness and the tuning fork tests which are rinnes test, webers test and ABC test(30 days)