| CTRI Number |
CTRI/2025/02/079945 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Marma Chikitsa in Karnanada(Tinnitus). |
|
Scientific Title of Study
|
A Comparative Study Of Efficacy Of Marma Chikitsa And Karnapuran In The Management Of Karnanada (Tinnitus). |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Solanki |
| 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 |
9589274010 |
| Fax |
|
| Email |
drvjsolanki287@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Gupta |
| Designation |
Reader 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 Vijay Solanki |
| 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 |
9589274010 |
| Fax |
|
| Email |
drvjsolanki287@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department Of Rachna Sharir Pandit Khushilal Sharma Govt (Auto) Ayurveda College and institute bhopal Madhya pradesh 462003 India |
|
|
Primary Sponsor
|
| Name |
Pandit Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 462003 |
| Address |
PG Department Of Rachna Sharir Pandit Khushilal Sharma Govt (Auto) Ayurveda College And Institute Bhopal Madhya Pradesh 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 Vijay Solanki |
Pt Khushilal Sharma Govt(Auto) Ayurveda College And Institute Bhopal Madhya Pradesh |
PG Department of Rachna Sharir Pt Khushilal Sharma Govt(Auto) Ayurveda College And Institute Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH |
09589274010
drvjsolanki287@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:H698||Other specified disorders of Eustachian tube. Ayurveda Condition: KARNA-NADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: sharshap tail, Reference: bhaishajya ratnawali, Route: Otic, Dosage Form: Taila, Dose: 10(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -karnapurana | | 2 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: dr. s.k. joshi, Procedure details: A steady & moderate pressure will be applied slowly & gently. Pressure will be increased gradually depending upon patient’s strength & tolerance)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of 20-60 yrs age of patients with intact tympanic membrane
Patient presenting with symptoms of karnanada(tinnitus)
Individuals of both the gender were included. |
|
| 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 |
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It Is Expected That At The End Of Study Scholar Will Be Able To A Comparative Study Of Efficacy Of Marma Chikitsa And Karnapuran In The Management Of Karnanada (Tinnitus). |
15days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marma Chikitsa Is Non Pharmaceutical Approach To Treat Karnanada(Tinnitus). |
15days |
|
|
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)
|
15/02/2025 |
| 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 usually caused by an underlying condition , such as age related hearing loss, an ear injury or a problem with the circulatory system but today non of them is free from adverse effects. in this study the assesment has done on the basis of subjective and objective parameter of Karnanada (Tinnitus ) thats why marma chikitsa has been taken. the overall effect of Marma Chikitsa is extremly significant. |