| CTRI Number |
CTRI/2023/05/052945 [Registered on: 19/05/2023] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Managment of Tinnitus through Ayurveda |
|
Scientific Title of Study
|
A Randomized Comparative Clinical study to evaluate the effect of Nirgundyadi Tail karnapoorna and Hingvadi Tail karnapoorna along with Ashwagandha Ghrita Orally in Karnanada(Tinnitus) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashu |
| Designation |
Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
| Address |
Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital
Kurukshetra HARYANA 136118 India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashu |
| Designation |
Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
| Address |
Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital
HARYANA 136118 India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashu |
| Designation |
Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
| Address |
Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital
HARYANA 136118 India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of shalakya tantra, Shri Krishna Ayush University, Sec 8, Umri road Kurukshetra, 136118 |
|
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Primary Sponsor
|
| Name |
Dr Akshay Garg |
| Address |
Shri Krishna Government Ayurvedic C0llege and Hospital Kurukshetra |
| Type of Sponsor |
Other [self] |
|
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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 Akshay Garg |
Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra |
OPD No.54, Shalakya tantra, Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra Haryana 136118 Kurukshetra HARYANA |
7206819940
drakshaygarg1@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H931||Tinnitus. Ayurveda Condition: KARNA-NADAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | karNapUraNam, करà¥à¤£à¤ªà¥‚रणमॠ| (Procedure Reference: Yogaratnakar, Procedure details: Patient is Advised to lie down on a a table in right or left lateral position. The area around the ear is massaged with luke warm oil for 5 minutes till the oil gets absorbed. Give hot fomentation with hot water bag untill the area becomes little erythematous then lukewarm Hingvadi Taila is poured into the patient ear canal upto filling of external auditory canal in each ear(2-2.5ml) for 100 Matrakala (Approx 2.5-3Minutes) once a day in evening(sayankala) 3 sittings of 8 days with 3 days gap bet) (1) Medicine Name: Hingvadi Taila, Reference: Gada Nigrah, Route: Otic, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 30 Days(2) Medicine Name: Ashwagandha Ghrita, Reference: Chakartdatta, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | karNapUraNam, करà¥à¤£à¤ªà¥‚रणमॠ| (Procedure Reference: Yogaratnakar, Procedure details: Patient is Advised to lie down on a a table in right or left lateral position. The area around the ear is massaged with luke warm oil for 5 minutes till the oil gets absorbed. Give hot fomentation with hot water bag untill the area becomes little erythematous then lukewarm Nirgundyadi Taila is poured into the patient ear canal upto filling of external auditory canal in each ear(2-2.5ml) for 100 Matrakala (Approx 2.5-3Minutes) once a day in evening(sayankala) 3 sittings of 8 days with 3 days gap ) (1) Medicine Name: Nirgundyadi Taila, Reference: Yogaratnakar, Route: Otic, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 30 Days(2) Medicine Name: Ashwagandha Ghrita, Reference: Chakardatta, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Duration: 30 Days |
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between age of 16-60 years irrespective of age, sex, caste, religion etc.
2.Patients will selected on the basis of signs and symptoms of Karnanada (Tinnitus).
3.Subjective type of tinnitus.
4.Patients willing to be registered for trial |
|
| ExclusionCriteria |
| Details |
1.Patients of age <16 years and >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, Immune compromised patients
7.Tinnitus associated with disease like – any growth of middle ear, Aneurysms of carotid artery, palatal myoclonus, and meningitis.
8.Degree of hearing loss greater than 40 dB.
9.Paitents not willing to be registered for trial. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in subjective and objective criteria of Karnanada |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study the Karananada from various ayurvedic texts.
2)To study the Tinnitus from modern texts.
3)To study the Karanapoorna from various ayurvedic texts.
4)Correlation of Karnanada with Tinnitus. |
30 Days |
|
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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" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Tinnitus is a common problem for millions of people, as epidemiological studies have reported its prevalence to be between 8 to 25.3% of the population of the United States.Similarly, population based studies conducted in other nations have found a similar prevalence of Tinnitus, ranging from 4.6% to 30%.Tinnitus is a common and debilitating disorder in India with a prevalence of more than 7% of the Indian population.It severely affects the quality of life of around 1-3% of the world.Tinnitus affects 10 to 15 % of adult general population. About 20 % of Tinnitus population requires serious clinical .The 7th – 13th of February 2022 brings us Tinnitus Awareness Week Recognized each year throughout the world in the first full week of February, the purpose of this week is to educate the public about the symptoms of tinnitus and how it affects people.The prevalence of tinnitus increases to 70-85% in the hearing-impaired population.
Available treatments for the management of Tinnitus are diverse. Highest evidence for clinical efficacy is available for cognitive-Behavioral therapies. Further established treatment includes counselling and various forms of sound therapy along with methods that attempt to increase input to the auditory system, such as hearing aids and masking of Tinnitus, Sedation and Tranquilizers.Despite its prevalence and effect on quality of life there is no evidence based guideline about management of Tinnitus till today and hence poses a challenge for finding such drugs or therapies in alternate systems of medicine.Ayurveda has a systematic line of treatment in the management of Karnanada. The Line of 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, AkathanaKarna is one of the Adhisthana of Vata Dosha..In Ayurveda since vata is the main dosha involved in karnanada disease. The treatment should be aimed at Vatashamana and Rasayana Karnapooran is an important therapy in karnarogas.It has unique quality of getting absorbed easily by the pores in the skin and there by act to supply the nutrition to nerves.Hence in present study, Karanpoorna with Nirgundyadi Tail and Hingvadi Tail possessing vatahara property is selected for the study. Ghrita is having“Sanskarasya Anuvartanatva so Ashwagandha Ghrita is selected for internal administration having Rasayana,Balya and Vatahara properties which can prevent age related degenerative changes in the inner ear.Hence it is proposed to undertake this study entitled "A Randomized Comparative Clinical Study to Evaluate the Effect of Nirgundyadi Tail Karnapoorna and Hingvadi Tail Karnapoorna along with Ashwagandha Ghrita Orally in Karnanada(Tinnitus)" |