| CTRI Number |
CTRI/2025/10/096394 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Shala Karnadhoopana ( Ayurvedic ear fumigation ) and Daruharidra Ghana Vati in patients with chronic ear discharge (Tubotympanic Chronic Suppurative Otitis Media) |
|
Scientific Title of Study
|
A Single Arm Clinical Study to Evaluate the Efficacy of Shala Karnadhoopana Along with Daruharidra Ghana Vati in the Management of Karnasrava (Tubotympanic Chronic Suppurative Otitis Media) |
| 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 Parvesh Kumar |
| Designation |
PG Scholar MS Shalakya Tantra |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Opd No 54 and 50 Department of Shalakya Tantra Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7027727567 |
| Fax |
|
| Email |
97parvesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashu |
| Designation |
Professor and Chairperson |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Opd No 54 and 50 Department of Shalakya Tantra Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashu |
| Designation |
Professor and Chairperson |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Opd No 54 and 50 Department of Shalakya Tantra Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9416553131 |
| Fax |
|
| Email |
drashukataria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved studies and research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Sector 8 Umri Road Kurukshetra pin 136118 |
| Type of Sponsor |
Other [Government Ayurvedic college] |
|
|
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 Parvesh Kumar |
Institute for Ayurved Studies and Research Hospital |
OPD No. 54 Shalakya Netra, Institute for Ayurved Studies and Research Hospital, sector 8 umri road kurukshetra 136118 Kurukshetra HARYANA
Kurukshetra
HARYANA
Kurukshetra
HARYANA |
7027727567
97parvesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Krishna Ayush University Kurukshetra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H661||Chronic tubotympanic suppurative otitis media. Ayurveda Condition: KARNA-SRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Daruharidra ghana vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | karNadhUpanam, कर्णधूपनम् | (Procedure Reference: Sushruta samhita , Procedure details: This procedure will be done for 15 days continuosly.)
(1) Medicine Name: Shala , Reference: Kaiyadeva nighantu, Route: Otic, Dosage Form: Not Applicable, Dose: 5(g), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex between the age of 16 and 60 years.
2. Patients with sign and symptoms of Karnasrava (Tubotympanic Chronic Suppurative Otitis Media)
3. Patients willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Age less than 16 years and more than 60 years.
2. Patients having the Atticoantral type of perforation.
3. Patients with systemic disorder - DM type1 and 2.
3. Pregnant women.
4. Patients having ear discharge associated with Haemorrhage, Malignancy of the ear.
5. Patients having other aural pathologies such as Otitis externa, Furunculosis, Fungal infection, Granuloma or polyp. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in scoring pattern in sign and symptoms of Karnasrava ( Tubotympanic Chronic Suppurative Otitis Media). |
15th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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
|
Among 28 ear disease mentioned by Acharya Sushruta Karnasrava is one of them . Available treatment protocol for Tubotympanic csom in modern system of medicine relies upon antibiotics and painkillers.
Tubotympanic csom is a frustrating entity for both patients and otolaryngologist as it requires long term treatment and medications used for its treatment has limitations like acidity,loss of hearing and unusual taste in mouth.
So the present study will be planned to study the effect of Ayurvedic formulation on Karnasrava.
Case will be selected from opd /ipd of Shri Krishna Ayush University Kurukshetra Haryana.
A written informed consent will be obtained after counselling of patients participating in the study.
Patients will be treated with Dhoopana therapy ,local application and oral drug. |