| CTRI Number |
CTRI/2024/07/070489 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can using Jambavadi taila and Saptang guggulu, two traditional Ayurvedic medicines, help treat chronic ear infections with discharg |
|
Scientific Title of Study
|
Evaluation of efficacy of Jambavadi Taila Karna pichu and Saptanga Guggulu orally in the management of Karnasrava (CSOM)-An open label double arm randomized controlled clinical trail
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kajal yadav |
| Designation |
PG SCHOLAR |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, 5th floor, Academic block , Department of Shalakya Tantra
South
DELHI
110076
India |
| Phone |
09013521915 |
| Fax |
|
| Email |
kajal.dehmiwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kundal |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, 5th floor, Academic block , Department of Shalakya Tantra
South
DELHI
110076
India |
| Phone |
7291887810 |
| Fax |
|
| Email |
drpankajkundal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
kajal yadav |
| Designation |
PG SCHOLAR |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, 5th floor, Academic block , Department of Shalakya Tantra
South
DELHI
110076
India |
| Phone |
09013521915 |
| Fax |
|
| Email |
kajal.dehmiwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda,NH-19,Gautampuri awas,Sarita vihar,New Delhi,110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
NH-19,Gautampuri Awas,Sarita Vihar, New Delhi,110076, 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 Kajal |
All India Institute of Ayurveda |
Hospital block, First floor,OPD no 102
South
DELHI |
09013521915
kajal.dehmiwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Ayurveda Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: KARNA-SRAVAH, (2) 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: MADHUKADI TAILA, Reference: BHAISHJYA RATNAWALI, Route: Otic, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -NA(2) Medicine Name: RASNADI GUGGULA, Reference: YOGRATNAKAR, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -LUKEWARM WATER), Additional Information: -NA | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: JAMBAVADI TAILA, Reference: CHAKRADATTA, Route: Otic, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -NA(2) Medicine Name: SAPTANGA GUGGULU, Reference: BHAVA PRAKASH, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -LUKEWARM WATER), Additional Information: -NA |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical features of Karnasrava (CSOM). |
|
| ExclusionCriteria |
| Details |
1. Patients having atticoantral type of perforation and total perforation.
2. Patient having ear discharge associated with haemorrhage, malignancy of ear and CSOM caused by tonsillitis, pharyngitis and allergic rhinitis
3. Having other aural pathologies like otitis externa, furunculosis, fungal infection, Granuloma, Polyp.
4. Having systemic diseases along with medications.
5. Patients have any intracranial, intratemporal and extratemporal complications of CSOM.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the clinical features of Karnasrava – Ear discharge |
0th day, 15th day, 30thday |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in other sign & symptoms of Karnasrava i.e Karnakandu, Karnabadhirya, Karnanaada, Karnashoola.
Changes in haematological parameters.
|
0th day, 15th day, 30th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is open label double arm randomized control clinical trail, to evaluate efficacy of Jambavadi Taila Karna pichu and Saptanga Guggulu orally in the management of clinical features of Karnasrava (Chronic Suppurative Otitis Media) on 0th,15th amd 30th day. |