| CTRI Number |
CTRI/2025/06/089778 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Karnapuran] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Marma Chikitsa on Tinnitus |
|
Scientific Title of Study
|
A Comparative Study On Efficacy Of Marma Chikitsa And Bilva Taila Karnapuran In The Management Of Tinnitus |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Saloni1234 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saloni Chauhan |
| Designation |
MD Scholar Rachna sharir |
| Affiliation |
Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9144308761 |
| Fax |
|
| Email |
salonichouhan80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Gupta |
| Designation |
Professor Department Of Rachna Sharir |
| Affiliation |
Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425647011 |
| Fax |
|
| Email |
drpankaj35@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saloni Chauhan |
| Designation |
MD Scholar Rachna sharir |
| Affiliation |
Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh |
| Address |
PG Department Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9144308761 |
| Fax |
|
| Email |
salonichouhan80@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Dept Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh 462003 |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Govt Auto Ayurveda College And Instituteda College And Institute Bhopal MP |
| Address |
PG Dept Of Rachna Sharir Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal MP India 462003 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saloni Chauhan |
Pt Khushilal Sharma Govt Auto Ayurveda College And Institute |
PG Deptartment Of Rachna Sharir
Bhopal
MADHYA PRADESH |
9144308761
salonichouhan80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pt Khushilal Sharma Govt Auto Ayurveda College And Institute Bhopal Madhya Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H931||Tinnitus. Ayurveda Condition: Tin, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: , Procedure details: Marma Chikitsa And Karnapuran/Once in a day/15 Days)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Of Either Sex In The Age Group Of 20-60 Years With Intact Tympanic Membrane.
Patients Presenting With Symptoms Of Tinnitus (Karnanada).
Patients Willing To Be Registered For Study. Patients Fulfilling Diagnostic Criteria.
|
|
| ExclusionCriteria |
| Details |
Congenital Deformity
Perforation Of Tympanic Membrane
Blockage Due To Ear Wax
Mentally Retarded Patients
Acute Suppurative Otitis Media & Chronic Suppurative Otitis Media
Sinusitis
Any other severe systemic disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study, scholar will be able to evaluate the effect of Marma Chikitsa and Bilva Taila Karnapuran in the management of Tinnitus (Karnanada) |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marma Chikitsa is Non Pharmaceutical Appraoch To Treat Tinnitus |
15 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
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tinnitus is an increasing health concern
across all strata of the general population. Tinnitus is the sensation of sound
in the absence of external and internal sound, that can be caused by a variety
of reasons and made worse by aggravating co-factors. The study compares
the effectiveness of two Ayurvedic treatments for management of Tinnitus.
Treatment Groups- Group 1 Marma Chikitsa-
15 patients of this group will be treated with Marma Chikitsa once a day for 15
days treatment involving specific pressure points (Marma points) to relieve the
symptoms.
Group 2-Karnapuran 15 patients of this
group will be treated with Bilva Taila Karnapuran for 15 days.
Expected outcome-The study aims to
determine which treatment is more effective in the managment of Tinnitus. |