Health Condition 1: H911- Presbycusis
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sceiences
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 60-75 years diagnosed with mild to moderate presbycusis (the pure tone audiometry (PTA) will be carried out for the octave frequencies between 0.25 to 8 kHz and pure tone average will be calculated for 500 Hz, 1 KHz and 2 KHz. The degree and type of hearing loss will be calculated based on PTA and patients with pure tone average of 26-70 dB HL will be included in the study.
Exclusion criteria
Exclusion criteria: 1. Conductive hearing loss and abnormal middle ear. 2. Current hearing aid user( > 3 months) 3. Patients with features of dementia. 4. Uncontrolled hypertension (Systolic BP >140mmHg and/or Diastolic BP >90mmHg) 5. Uncontrolled Diabetes (HbA1c >8%). 6. Patients with Very high Dyslipidemia (T.Chol > 240 mg / dL, LDL >190mg/dL, HDL >60, Triglycerides > 500 mg/dL ) NCEP – ATP III Classification 7. Patients with Aspartate Amino Transferase (AST) and/ or Alanine Amino Transferase (ALT) > 2 times upper normal limit, or 8. Patients with S. Creatinine > the upper limits of the normal. 9. History of malignancy within 5 years. 10. History of cerebro vascular accident within one year 11. History of use of ototoxic drugs, psychiatric and nervous system drugs. 12. H/O Hypersensitivity to the trial drug or any of its ingredients. 13. Continuing addiction to smoking and usage of tobacco in any form 14. Individuals simultaneously or previously (within 30 days prior to investigation start) participate in a clinical investigation using experimental drugs or devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hearing protection [Time frame-24 weeks] Assessed bydifference in the average of 500 Hz, 1 KHz and 2 KHz in PTA from baseline and after 24th week of intervention. It also includes changes in Brainstem Evoked Response Audiometry (BERA) and difference in Speech recognition threshold and Speech discrimination score. All audiometric evaluations will be done in acoustically treated sound proof rooms. Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Global cognitive function protection [Time frame-24 weeks] Assessed by the difference in the Mini Mental State Examination (MMSE) score from baseline and after 24th week of intervention. Timepoint: 24 weeks;Tinnitus suppression. [Time frame-24weeks] Assessed by thedifference in the tinnitus functional index from baseline and after 24th week of intervention. Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr Krishna Kumar V
National Ayurveda Research Institute for Panchakarma, Cheruthuruthy
Outcome results
None listed