| CTRI Number |
CTRI/2024/09/074471 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of Kshaumadi karnadhoopana and Rasnaadi guggulu in Karnasrava (CSOM) |
|
Scientific Title of Study
|
Clinical Evaluation Of Kshaumadi Karnadhoopana And Rasnaadi Guggulu in Karnasrava (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 Arun Kumar |
| Designation |
Assistant Professor (Shalakya Tantra) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) |
| Address |
O.P.D No 05 P.G. Department of Shalakya Tantra Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Hardwar
UTTARANCHAL
249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9634918909 |
| Fax |
|
| Email |
drarun2004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar |
| Designation |
Assistant Professor (Shalakya Tantra) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) |
| Address |
O.P.D No 05 P.G. Department of Shalakya Tantra Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Hardwar
UTTARANCHAL
249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9634918909 |
| Fax |
|
| Email |
drarun2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandhya Tewari |
| Designation |
PG Scholar (Shalakya Tantra) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) |
| Address |
O.P.D No 05 P.G. Department of Shalakya Tantra Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Hardwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7017727655 |
| Fax |
|
| Email |
tewarisandhya355@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus,Uttrakhand Ayurved University,Haridwar,249401,India |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University Dehradun |
| Address |
Uttarakhand Ayurved University, Station Road, Harrawala, Dehradun-248001 Uttarakhand, India
|
| Type of Sponsor |
Government medical 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 Sandhya Tewari |
Rishikul Ayurvedic College |
O.P.D No 05, P.G. Department of Shalakya Tantra, Haridwar, Uttarakhand Ayurved University (Dehradun) Hardwar UTTARANCHALÂ 249401Â India
Hardwar
UTTARANCHAL |
7017727655
tewarisandhya355@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
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 | Classical | | (1) Medicine Name: Rasnaadi guggulu, Reference: Yogratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | karNadhUpanam, करà¥à¤£à¤§à¥‚पनमॠ| (Procedure Reference: Sushruta samhita, Procedure details: This procedure will be done for 21 days in three sittings of 5-5 days with a gap of 3 days in each sitting.Total duration of procedure is 10 minutes.)
(1) Medicine Name: Kshaumadi , Reference: Sushruta samhita, Route: Topical, Dosage Form: Not Applicable, Dose: 8(g), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to register
2.Patients within the age group of 16-60 years
3.Patients having specific signs and symptoms of CSOM and karnasrava
4.Tubotympanic (SAFE) type of CSOM
5.Active cases of Tubotympanic CSOM with chronicity less than 2yrs |
|
| ExclusionCriteria |
| Details |
1 Patients not willing to participate in the study.
2 Pregnant women and lactating mothers.
3 Patients with the complications of CSOM.
4 Systemic diseases like DM, Meningitis, Tuberculosis, etc.
5 Atticoantral (Unsafe) type of CSOM.
6 Non- vaccinated Covid-19 patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in sign and symptoms-
a)Earache
b)Discharge
c)Consistency of discharge
d) TM perforation size
e) External examination by torch and otoscopic examination to rule out TM perforation size
f)Hearing assessment done by PTA,Rinne and Weber test
|
Followup at an interval of 15 days and 30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in sign & symptoms-
a)Earache
b)Discharge
c)Consistency of discharge
d) TM perforation size
e) External examination by torch & otoscopic examination to rule out TM perforation size
|
Followup at interval of 15 days & 30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/10/2024 |
| 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 diseases mentioned by Acharya Sushruta Karnasrava is one of them. Available treatment protocols for CSOM in modern system of medicine relies upon antibiotics and pain killers.
CSOM is a frustrating entity for both patients and otolaryngologists 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 Rishikul Campus Hospital, U.A.U. Haridwar (UK) INDIA.
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. |