| CTRI Number |
CTRI/2022/03/040863 [Registered on: 07/03/2022] Trial Registered Prospectively |
| Last Modified On: |
18/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Asatmyendriyartha Samyoga w.s.r to Noise Induced Hearing Loss - A Clinical Study
|
|
Scientific Title of Study
|
Asatmyendriyartha Samyoga w.s.r. to Noise Induced Hearing Loss (NIHL) - An Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lasitha Sanal |
| Designation |
PhD Scholar |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
Dept Of Ayurveda Samhita Avum Siddhanta, Parul Institute Of Ayurveda, Parul University, Limda, Waghodia, Vadodara, 319760, Gujarat, India
Dept Of Ayurveda Samhita Avum Siddhanta, Parul Institute Of Ayurveda, Parul University, Limda, Waghodia, Vadodara, 319760, Gujarat, India
Vadodara
GUJARAT
319760
India |
| Phone |
8921552832 |
| Fax |
|
| Email |
lasithasanal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lasitha Sanal |
| Designation |
PhD Scholar |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
Dept Of Ayurveda Samhita Avum Siddhanta, Parul Institute Of Ayurveda, Parul University, Limda, Waghodia, Vadodara, 319760, Gujarat, India
Dept Of Ayurveda Samhita Avum Siddhanta, Parul Institute Of Ayurveda, Parul University, Limda, Waghodia, Vadodara, 319760, Gujarat, India
Vadodara
GUJARAT
319760
India |
| Phone |
8921552832 |
| Fax |
|
| Email |
lasithasanal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lasitha Sanal |
| Designation |
PhD Scholar |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
Dept Of Ayurveda Samhita Avum Siddhanta, Parul Institute Of Ayurveda, Parul University, Limda, Waghodia, Vadodara, 319760, Gujarat, India
Dept Of Ayurveda Samhita Avum Siddhanta, Parul Institute Of Ayurveda, Parul University, Limda, Waghodia, Vadodara, 319760, Gujarat, India
Vadodara
GUJARAT
319760
India |
| Phone |
8921552832 |
| Fax |
|
| Email |
lasithasanal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept Of Ayurveda Samhita Avum Siddhanta, Parul Institute Of Ayurveda, Parul University, Limda, Waghodia, Vadodara, 319760, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Dr Lasitha Sanal |
| Address |
Dept Of Ayurveda Samhita Avum Siddhanta, Parul Institute Of Ayurveda, Parul University, Limda, Waghodia, Vadodara, 319760, Gujarat, India |
| Type of Sponsor |
Other [Self Financing] |
|
|
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 Manisha Dunghav |
Parul Institute Of Ayurveda |
Dept Of Ayurveda Samhita Avum Siddhanta, Ground Floor, Room no.10, Parul Institute Of Ayurveda, Parul University, Limda, Waghodia, Vadodara, 319760, Gujarat, India
Vadodara
GUJARAT |
8238416876
manisha.dunghav28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PARUL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NOISE INDUCED HEARING LOSS |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Administering Noise Cancellation Headsets and Aum Mantra Chanting | 30 samples will be subjected for Aum mantra chanting for 10 minutes morning and evening along with usage of Noise Cancellation headsets during work time. | | 2 | Comparator Arm (Non Ayurveda) | | - | Noise Cancellation Headsets | Administering noise cancellation headsets to 30 samples during their duty time | | 3 | Comparator Arm (Non Ayurveda) | | - | Aum Mantra Chanting | 30 samples will be subjected to aum mantra chanting for a period of 10 minutes morning and evening | | 4 | Comparator Arm (Non Ayurveda) | | - | Control Group | 30 samples will not be administered any of the interventions |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals between the age group of 18-40 years irrespective of gender.
Individuals who are using regular 8-12 hrs of headphone for atleast1 year.
Individuals willing to participate and ready to give informed consent.
|
|
| ExclusionCriteria |
| Details |
Individuals who are suffering from any kind of ear diseases.
Individuals who are suffering from any systemic, congenital or metabolic disorders.
Individuals who are suffering from psychological disorders.
Individuals who age related degeneration.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There are definite relations between Asatmyendriyartha samyoga and noise induced hearing loss(NIHL) and has effect of meditation and technical alterations in it. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aum meditation and Noise cancellation headsets may have stress relieving effects on emotional factors |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
31/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM An interventional
study on Asatmyendriyartha samyoga w.s.r to noise induced
hearing loss(nihl) and effect of meditation and technical alterations in it. OBJECTIVES OF STUDY: To assess the importance of Asatmyendriyartha Samyoga in
the manifestation of a disease. To apply the concept of Asatmyendriyartha Samyoga in
individuals with habit of prolonged usage of haeadphones. To evaluate interventionaly the incidence of Noise
induced Hearing Loss w.r.t astmyendriyartha Samyoga of Srotrendriya . HYPOTHESIS Null Hypothesis There are no definite relations between Asatmyendriyartha samyoga and noise induced hearing loss(NIHL) and has no effect of
meditation and technical alterations in it.. (H0) Proposed Hypothesis There are definite relations between Asatmyendriyartha
samyoga and noise induced hearing
loss(NIHL) and has effect of meditation and technical alterations in
it. (H1) METHODOLOGY: Source of Data: A.Literary: The review of literature includes screening of classical Ayurvedic literature,
contemporary literature, modern literature, journals and internet sources to
collect sufficient data for the study. B. Interventional Study: Includes 4 instrumental interventions to assess various parameters. They
are: 1. Doshic Parameter - Rasa sara Assesment
Questionnaire 2. Phycological Assesment- Adult Temperament
Questionnaire 3. Disease Assesment - Noise Induced Hearing
Loss Questionnaire 4. Diagnostic Tool – Audiometry Method of collection of Data: Study Design: Literary Study, Interventional Study to
evaluate the incidence of Noise induced Hearing Loss w.r.t astmyendriyartha
Samyoga of Srotrendriya Literary Study: The review of literature
includes screening of classical Ayurvedic literatures,
contemporary literature, modern literature, journals and internet sources to
collect sufficient data for the study. Interventional Study: Study will be conducted in following stage: Stage I: Exploration about the concept and practical applicability of astmyendriyartha Samyoga of Srotrendriya. Stage II: The aim is to evaluate effect of meditation and technical alterations
in Asatmyendriyartha samyoga w.s.r to noise induced hearing
loss(nihl). 90 volunteers will be selected and assessed using all the four
assessment tools ie three scales for assessing the Doshik, Psychological and
Disease along with Audiometry.Volunteers of either sex are grouped randomly into 4
groups for the study each
group will have 30 volunteers Group I – Advised to do meditation for 10 min before and After
work Group II – Advised to use Noise Canceling Earphones Group III - Advised to do meditation for 10 min before and after work
along with using Noise canceling earphones Group IV- Control Group
|