| CTRI Number |
CTRI/2025/02/081214 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Karna Nada |
|
Scientific Title of Study
|
A Randamized active controle clinical trial to evaluate the effect of Apamarga kshara taila karnapichu and karnapoorana in the management of Karnanada (Subjective Tinntus) |
| 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 Roopa L |
| Designation |
Professor |
| Affiliation |
Sushrutha Ayurvedic Medical College |
| Address |
Professor and HOD Department of Shalakya Tantra Sushrutha Ayurvedic Medical College and Hospital Bangalore S Vyasa Prashanti Kuteera
Bangalore
KARNATAKA
560105
India |
| Phone |
09741112749 |
| Fax |
|
| Email |
rooopi3110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa L |
| Designation |
Professor |
| Affiliation |
Sushrutha Ayurvedic Medical College |
| Address |
Professor and HOD Department of Shalakya Tantra Sushrutha Ayurvedic Medical College and Hospital Bangalore S Vyasa Prashanti Kuteera
Professor and HOD Department of Shalakya Tantra Sushrutha Ayurvedic Medical College and Hospital Bangalore S Vyasa Prashanti Kuteer - 9741112749
Bangalore
KARNATAKA
560105
India |
| Phone |
09741112749 |
| Fax |
|
| Email |
rooopi3110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa L |
| Designation |
Professor |
| Affiliation |
Sushrutha Ayurvedic Medical College |
| Address |
Professor and HOD Department of Shalakya Tantra Sushrutha Ayurvedic Medical College and Hospital Bangalore S Vyasa Prashanti Kuteera
Bangalore
KARNATAKA
560105
India |
| Phone |
09741112749 |
| Fax |
|
| Email |
rooopi3110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sushrutha Ayurvedic Medical College and Hospital Prashanthi Kuteera S Vyasa University Jigani (H) Anekal (T) |
|
|
Primary Sponsor
|
| Name |
Dr Roopa L |
| Address |
Professor and HOD Department of Shalakya tantra Sushrutha Ayurveda Medical College and Hospital Prashanthi Kuteera jigani Bangalore |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 Roopa L |
Sushrutha Ayurvedic Medical College and Hospital |
Dr.Roopa.L, Professor and HOD Department of Shalakya Tantra Sushrutha Ayurvedic Medical College and Hospital Room No 7 Bangalore S Vyasa Prashanti Kuteera
Bangalore
KARNATAKA |
09741112749
rooopi3110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC SAMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H833||Noise effects on inner ear. Ayurveda Condition: KARNA-NADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
•Subjects Age group between 35 to 70 yrs.
•The Subjects were selected irrespective of sex, occupation, religion and socioeconomic state for the study with consent taken by each individuall.
•Patients suffering from Tinnitus with different sounds in ear like Buzzing, Roaring, Clicking, Hissing, and humming are included
•Diagnosed cases of Sensory Neural Hearing lose are included for the study Chronicity less than 5 years
•Diagnosed Case of Hyperlipidemia with symptoms of Tinnitus
|
|
| ExclusionCriteria |
| Details |
TMJ Disorders
Nasal Diseases Polyps DNS
Other Systemic Diseases DM etc |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Apamargakshara taill will have effect when it is used in the form of either Karnapichu |
30 Samples of Karnanada devided in to 2 groups 15 each in group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Apamargakshara taila will give results in Karnanada when used as either Karnapichu or Kanapoorana |
with in 1 week or 1 week |
|
|
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)
|
01/07/2025 |
| 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="0"
Months="3"
Days="15" |
|
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 - YES
- What data in particular will be shared?
Response (Others) - Individual participant Data
- What additional supporting information will be shared?
Response - Clinical Study Report
Response (Others) - Clinical Study Report
- Who will be able to view these files?
Response (Others) - Researches
- For what types of analyses will this data be available?
Response (Others) - For individual participant data meta analysis
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included Through link).
- For how long will this data be available start date provided 01-07-2025 and end date provided 01-09-2025?
Response (Others) - Immediately following publications
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The ear is referred to in that as Karna Indriya. Numerous preventive and therapeutic strategies to maintain healthy ears were outlined by several Acharyas. However, if diseases do arise, there are numerous therapeutic options. Many preventive The science of life is Ayurveda. It is one of the oldest medical disciplines in existence. By adhering to different dos and don’ts, Ayurveda assists people in maintaining their health. It is brimming with diverse disease management strategies. The body’s 5 sense organs are thought to be crucial components. People are unable to practice Dinacharya and Ritucharya due to changes in lifestyle, sedentary employment, and eating habits, which may cause a number of ailments.The words "Nada" or "Ninada" describe something that causes the ear to hear rhythmic noises. Different sounds are produced when the vitiated Vata dosha enters other channels or is ringed by Kapha dosha in Shabdavaha Srotas[1]. Karnanada is the term for the ear structures, such as Bheri, Mrudanga, Shankha, etc Karnanada and Tinnitus have a relationship in contemporary science. The perception of sound without any external input is known as tinnitus. Nearly 15% of adults experience tinnitus, making it fairly prevalent. It is a phenomenon when, in the absence of external stimuli, a sound perception that seems to originate in the head occurs. With or without hearing loss, the symptoms might be unilateral or bilateral and sound like ringing, hissing, whistling, humming, buzzing, chirping, or clicking noises In a related but distinct method called Nasapana, where the drugs are also administered via the nasal channel with a slight difference. The primary distinction between Nasya and Nasapana is that the former administers medication through the nose and expels it through the mouth, while the latter administers medication by ingestion |