| CTRI Number |
CTRI/2025/04/083919 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Managment of Tinnitus through Ayurveda. |
|
Scientific Title of Study
|
A Randomized Open Labelled Comparative Clinical Study to
Evaluate the Efficacy of Madhukadi Tail Karnapoorna and Apamargkshar Tail
Karnapoorna along with Goghrita orally 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 AARTI KUMARI |
| Designation |
MS SHALAKYA TANTRA PG SCHOLAR |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH SHRI KRISHNA AYUSH UNIVERSITY , KURUKSHETRA HARYANA |
| Address |
OPD NO 50, PG DEPARTMENT OF SHALAKYA TANTRA,INSTITUTE FOR AYURVED STUDIES AND RESEARCH,SHRI KRISHNA AYUSH UNIVERSITY SECTOR 8 UMRI ROAD
KURUKSHETRA HARYANA
Kurukshetra HARYANA 136118 India |
| Phone |
7404088194 |
| Fax |
|
| Email |
aartichahal77@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashu |
| Designation |
HOD and Chairperson |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no-108. 1st floor , Department of Shalakya Tantra, Institute for Ayurved Studies and Research, Shri Krishna
Ayush University
Umri Road
Sector-8, Kurukshetra
Kurukshetra HARYANA 136118 India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR AARTI KUMARI |
| Designation |
MS SHALAKYA TANTRA PG SCHOLAR |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH SHRI KRISHNA AYUSH UNIVERSITY , KURUKSHETRA HARYANA |
| Address |
OPD NO 50, PG DEPARTMENT OF SHALAKYA TANTRA,INSTITUTE FOR AYURVED STUDIES AND RESEARCH,SHRI KRISHNA AYUSH UNIVERSITY SECTOR 8 UMRI ROAD
KURUKSHETRA HARYANA
Kurukshetra HARYANA 136118 India |
| Phone |
7404088194 |
| Fax |
|
| Email |
aartichahal77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra, Institute For Ayurved Studies Research Shri Krishna Ayush University Sec 8 Umri road 136118 Kurukshetra Haryana |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies Research Shri Krishna Ayush University Kurukshetra Haryana |
| Address |
Institute For Ayurved Studies Research Shri Krishna Ayush University Sec 8 Umri road 136118 Kurukshetra Haryana |
| Type of Sponsor |
Research institution and hospital |
|
|
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 AARTI KUMARI |
Institute For Ayurved Studies & Research, Shri Krishna Ayush University Kurukshetra, Haryana |
OPD NO 50, PG DEPARTMENT OF SHALAKYA TANTRA,INSTITUTE FOR AYURVED STUDIES AND RESEARCH,SHRI KRISHNA AYUSH UNIVERSITY SECTOR 8 UMRI ROAD 136118
KURUKSHETRA HARYANA Kurukshetra HARYANA |
07404088194
aartichahal77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI KRISHNA AYUSH UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H838||Other specified diseases of innerear. Ayurveda Condition: KARNA-NADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | karNapUraNam, कर्णपूरणम् | (Procedure Reference: Sharangdhar samhita, Procedure details: Karnapoorana is a procedure in which luke warm Apamargkshar tail is slowly poured into the affected ear(till EAC fills). This procedure begins with an ear and partial head massage. Duration of the procedure is 100 matra kala.)) (1) Medicine Name: Apamargkshar tail, Reference: Sharangdhar samhita, Route: Otic, Dosage Form: Taila, Dose: 15(drops), Frequency: od, Duration: 30 Days(2) Medicine Name: Goghrit, Reference: Sushrut Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: hs, Duration: 30 Days | | 2 | Intervention Arm | Procedure | - | karNapUraNam, कर्णपूरणम् | (Procedure Reference: Sharangdhar samhita, Procedure details: Karnapoorana is a procedure in which warm Madhukadi tail is slowly poured into the affected ear(till EAC fills). This procedure begins with an ear & partial head massage. Duration of the procedure is 100 matra kala.) (1) Medicine Name: Madhukadi tail, Reference: Bhaisajya Ratnavali, Route: Otic, Dosage Form: Taila, Dose: 15(drops), Frequency: od, Duration: 30 Days(2) Medicine Name: Goghrit, Reference: Sushrut samhita, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: hs, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the age of 16-60 years irrespective of age, sex, caste, religion etc.
2. Patients will be selected based on symptoms of Karnanada (Tinnitus).
3. Subjective type of tinnitus.
4. Tinnitus without vertigo. |
|
| ExclusionCriteria |
| Details |
1. Patients of age less than 16 years and more than 60 years
2. Patients suffering from any chronic debilitating disease like DM, HTN, KOCH’S
and with other ear pathologies.
3. Objective type of Tinnitus.
4. Cases of tinnitus which required surgical intervention.
5. CSOM, Otomycosis, Perforated TM.
6. Pregnant and Immuno-compromised patients
7. Tinnitus associated with disease like – any growth of middle ear, Aneurysms of the carotid
artery, palatal myoclonus, Meniere’s disease and meningitis.
8. Degree of hearing loss greater than 40 dB.
9. Drug induced tinnitus e.g. high dose aspirin, ibuprofen, diclofenac etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in karnanada symptoms and objective parameters like masking test for tinnitus and audiometry |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life will be improved. Decrease in Tinnitus Handicap Inventory score Improvement in mild hearing loss |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/04/2025 |
| 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 Yet Recruiting |
| 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
|
As epidemiological studies have shown, tinnitus is a common problem for millions of people reports its prevalence to be between 8 and 25.3% of the United States population. Similar findings were made by population studies conducted in other countries prevalence of tinnitus ranging from 4.6% to 30%. This disorder in India is with a prevalence of more than 7% of the Indian population. It is serious, it affects the quality of life of about 1-3% of the world. Tinnitus affects 10 to 15% of adults’ general population. About 20% of the tinnitus population requires serious clinical. Tinnitus Awareness Week was between 5 and 11 February 2024. Aim of this campaign was to educate and raise awareness of tinnitus, provide support to those affected and promote research into effective treatment. The treatments available for tinnitus are varied. The ultimate proof for clinical efficacy is available for cognitive- behavioral therapies. Further established treatment includes counseling and various forms of sound therapy along with methods that attempt to increase input to the auditory system such as hearing aids and masking Tinnitus, sedation and tranquilizers. Despite its prevalence and impact on quality of life there are no evidence- based guidelines for the treatment of tinnitus to date, and therefore presents a challenge to find such drugs or therapies in alternative systems of medicine. Ayurveda has a systematic line of treatment under the management of Karnanada. Line from treatment in Ayurveda for four diseases viz. Karnashoola, Pranada, Karnashweda and Badhirya is similar. The general line of treatment for Karnarogas is Ghritapana, Rasayana, Avyayama, Ashirasnana, Brahmacharya, Akathana. Karna is one of the Adhisthana Vata Dosha. In Ayurveda, vata is the main one dosha involved in Karnad disease. Treatment should be directed at Vatashaman and Rasayan Karnapooran which is an important therapy in karnarogas. It has a unique the quality is easily absorbed by the pores in the skin and acts on the supply their nutrition for the nerves. Therefore, in this study, Karanpoorna with Madhukadi tail and Apamargkshar Tail possessing vatahara property is selected for the study. Administration of Goghrita orally pacifies Vata and improves the strength of the nerves, it has Rasayana, Balya and Vatahara properties which can prevent age related degenerative changes in the internal ear. Hence it is proposed to undertake this study entitled “A Randomized Open Labelled Comparative Clinical Study to Evaluate the Efficacy of Madhukadi Tail Karnapoorna and Apamargkshar Tail Karnapoorna along with Goghrita orally in the management of Karnanada (Tinnitus)”. |