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CTRI Number  CTRI/2023/02/050141 [Registered on: 27/02/2023] Trial Registered Prospectively
Last Modified On: 21/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study effect of Ashwagandharishta and polybion syrup in early presbyacusis. 
Scientific Title of Study   Randomized controlled clinical trial to study efficay of ashwagandharishta and polybion syrup in early presbyacusis in improving speech discrimination score. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kiran Kannade 
Designation  MS Scholar Shalakyatantra 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of shalakyatantra 2nd floor 583/2 Rasta Peth Pune
583/2 Rasta Peth Pune
Pune
MAHARASHTRA
411011
India 
Phone  9822064368  
Fax    
Email  kirankannade@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sangeeta Salvi 
Designation  HOD Shalakyatantra Department 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of shalakyatantra 2nd floor 583/2 Rasta Peth Pune
583/2 Rasta Peth Pune
Pune
MAHARASHTRA
411011
India 
Phone  9822082795  
Fax    
Email  salvisangeeta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Kiran Kannade 
Designation  MS Scholar Shalakyatantra 
Affiliation  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of shalakyatantra 2nd floor 583/2 Rasta Peth Pune
583/2 Rasta Peth Pune
Pune
MAHARASHTRA
411011
India 
Phone  9822064368  
Fax    
Email  kirankannade@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital 
 
Primary Sponsor  
Name  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of shalakyatantra 2nd floor 583/2 Rasta Peth Pune 411011 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran Kannade  Seth Tarachand Ramnath Ayurvedic Hospital Pune  Tilak Ayurveda Mahavidyalaya Department of shalakyatantra ENT OPD 15 1st floor 583/2 Rasta Peth Pune
Pune
MAHARASHTRA 		 9822064368

kirankannade@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tilak Ayurveda Mahavidyalaya Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H905||Unspecified sensorineural hearingloss. Ayurveda Condition: KARNAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ashwagandharishta, Reference: Bhaishajya ratnavali vidyotini tikka 21, Route: Oral, Dosage Form: Arishta, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information:
2Comparator Arm (Non Ayurveda)-Polybion syrupPolybion Syrup 100 ml belongs to a class of medications called nutritional supplements used to treat nutritional deficiencies and vitamin B12 deficiency. A nutritional deficiency occurs when the body does not absorb or get enough nutrients from food. Vitamins and minerals are necessary for body development and the prevention of diseases. Polybion syrup will be administered through oral route as 10 ml bd for 3 months.
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients having presbyacusis.
Patients ready to give consent 
 
ExclusionCriteria 
Details  Patients having history of immunosuppresant disorder.
patients having perforated tympanic membrane.
Patients having hearing aid. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sample size 44 improvement in speech discrimination score   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Sample size 44 improvement in speech discrimination score   6 months 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/02/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study will be intervened by the treatment of ashwagandharishta and polybion syrup to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to improvement in speech discrimination score. The speech discrimination score will be calculated before treatment, during treatment and after treatment. The effect of treatment results will be assessed in regard to improvement in speech discrimination score. 
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