| CTRI Number |
CTRI/2020/06/025721 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
21/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare The efficacy of ashwagandha ghrita orally and ksheerabala 101 taila nasya in sensorineural hearing loss |
|
Scientific Title of Study
|
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 Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Gopalani |
| Designation |
PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science And Research |
| Address |
Sri Sri College of Ayurvedic Science And Research, 21st KM, Kanakpura Road,PO- Udayapura
Bangalore
Sri Sri College of Ayurvedic Science And Research, 21st KM, Kanakpura Road,PO- Udayapura
Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
7597936995 |
| Fax |
|
| Email |
goplani.pooja3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Gopalani |
| Designation |
PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science And Research |
| Address |
Sri Sri College of Ayurvedic Science And Research, 21st KM, Kanakpura Road,PO- Udayapura
Bangalore
Sri Sri College of Ayurvedic Science And Research, 21st KM, Kanakpura Road,PO- Udayapura
Bangalore
KARNATAKA
560082
India |
| Phone |
7597936995 |
| Fax |
|
| Email |
goplani.pooja3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandhya Ganesh |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science And Research |
| Address |
Department of PG Studies Shalakya Tantra Sri Sri College of Ayurvedic Science And Research, 21st KM, Kanakpura Road,PO- Udayapura
Bangalore
Department of PG Studies Shalakya Tantra Sri Sri College of Ayurvedic Science And Research, 21st KM, Kanakpura Road,PO- Udayapura
Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9449349263 |
| Fax |
|
| Email |
drsandyaganeshk@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI SRI College of Ayurvedic Science And Research,21KM,Kanakpura road,PO-Udayapura, Bangalore-560082 |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Gopalani |
| Address |
Sri Sri College of Ayurvedic Science and Research, Bangalore |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Gopalani |
Sri Sri College of Ayurvedic Science And Research |
Sri Sri College of Ayurvedic Science And Research, 21st KM, Kanakpura Road,PO- Udayapura
Bangalore
Bangalore
KARNATAKA |
7597936995
goplani.pooja3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H833||Noise effects on inner ear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandha ghrita orally |
subjects will be given 12 gm ashwagandha ghrita once a day with warm milk at bed time for 30 days the assessment will be done 8th , 31st day follow up on 60th day |
| Intervention |
Marsha nasya with ksheerabala 101 along with Ashwagandha Ghrita |
orally for 30 days and nasya for 7 days. assessment on 8th, 31st day. follow up on 60th day |
| Comparator Agent |
Marsha nasya with ksheerabala taila 101 |
Marsha nasya with ksheerabala taila 101 for 7 days.Procedure of marsha nasya. Purva Karma: Mridhu Abhyanga with murchita tila taila will be done on scalp ,forehead, face and neck followed by bashpa sweda with padded eyes .Pradhana karma: subject is asked to lie down in supine position , with head slightly tilted back and legs slightly raised. Marsha nasya with 8 bindus will be administered to both nostrils daily morning in empty stomach for 7 days. Paschat karma: Dhumapana with haridra dhoom varti . Kavala with 7 days .
assessment on 8th day. follow up 31st and 60th day |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with Sensorineural Hearing Loss.
2. Subjects with Intact Ear Drum.
3. Subjects in the age group 40-60 years.
|
|
| ExclusionCriteria |
| Details |
1 Subjects associated with Tympanic Membrane Perforation.
2 Subjects of Congenital Hearing Loss.
3 Subjects with Conductive Hearing Loss and Mixed Hearing loss.
4 Subjects with Otorrhoea.
5 Subjects that are contra-indicated for Nasya.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in hearing ability and it will be measured by pure tone audiometry |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
01/08/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
will be published in all UGC approved journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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 . |