| CTRI Number |
CTRI/2026/01/100008 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate the Efficacy of Karnapoorana with Erandadi Taila in the patients of Karnanada (Tinnitus). |
|
Scientific Title of Study
|
An Open Label Randomized Controlled Clinical Study to Evaluate the Efficacy of Erandadi Taila Karnapoorana in the Management of Karnanada w.s.r. to 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 Vijayant Bhardwaj |
| Designation |
HOD Professor PG Department of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
176115
India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayant Bhardwaj |
| Designation |
HOD Professor PG Department of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
176115
India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aaina Jishtu |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv GandhiGraduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018846139 |
| Fax |
|
| Email |
jishtuaaina1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola,
Kangra, H.P. |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital,
Paprola, Distt. Kangra, H.P. 176115, India |
| 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 Vijayant Bhardwaj |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
OPD No. 201, Rajiv
Gandhi Govt Post
Graduate Ayurvedic
College and Hospital,
Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
Shimla
HIMACHAL PRADESH |
9418017568
bhardwajvijayant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. 176115 India |
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 | Intervention Arm | Procedure | - | karNapUraNam, कर्णपूरणम् | (Procedure Reference: Sharandhara Samhita / Uttar khand/ chapter 11/ shloka no. 126, Procedure details: Erandadi Taila will be gently warmed by keeping in luke warm water. Then snehan and swedan of ear will be done.Gentle massage of the ear for a short period done.Mild hot fomentation around the ear will be done. The external auditory canal will be straightened by pulling the pinna backward and upwards. Erandadi Taila will be poured drop by drop till the ear canal will be filled up.The root of the ear is gently massaged. The excess oil will be taken out of the external auditory canal by dry cotton. After retaining the Erandadi Taila for 5 minutes the ear will be cleaned with dry cotton mopping. )
(1) Medicine Name: Erandadi Taila, Reference: अ.हृ. उ.18/23-24, Route: Otic, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Duration: 15 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Caroverine | Caroverine is a quinoxaline derivative, otoneuroprotective glutamate antagonist, vasodilator and Calcium channel blocker.
Tinnitus is associated with excessive glutamate activity in the cochlear synapses, leading to hyper-excitation of auditory neurons.
Caroverine acts as an NMDA (N-Methyl-D-Aspartate) receptor antagonist, reducing excitatory neurotransmission and stabilizing neural activity in the cochlea.It blocks calcium channels, preventing excessive intracellular calcium accumulation, which contributes to neuroprotection and reduced excitability in auditory pathways.Caroverine has free radical scavenging properties, helping to counteract oxidative stress that may contribute to tinnitus. As a vasodilator, it increases the blood flow to the ear.
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with clinical features of Karnanada as per classics irrespective of sex, caste and religion.
2.Patients willing and able to participate
in the trial. |
|
| ExclusionCriteria |
| Details |
1.Individuals not willing to undergo the clinical trial.
2.History of hypersensitivity to any of the trial drug or other ingredients.
3.Patient suffering from any chronic debilitating diseases like Diabetes mellitus, Hypertension, Hyperthyroidism, Hypothyroidism, Hyperlipidemia.
4.Patients with congenital deformities.
5.Pregnant and Immunocompromised individuals.
6.Ear pathologies like Glomus tumor middle ear, ASOM, Meniere’s disease, otitis media with effusion.
7.Perforated tympanic membrane.
8.Patient who needs surgical management.
9.Any other condition which the principal investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Karnanada w.s.r to Tinnitus |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in quality of life of patients.
|
15th day and 30th day |
|
|
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)
|
16/02/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my research work after completion of the trial as soon as possible. Patients will be selected from OPD/IPD of RGGPG Ayurvedic College and Hospital,Paprola. 2 groups of 30 patients will be registered and assessed to evaluate the efficacy of Erandadi Taila Karanpoorana in the management of Karnanada w.s.r. to Tinnitus. |