| CTRI Number |
CTRI/2023/11/059786 [Registered on: 14/11/2023] Trial Registered Prospectively |
| Last Modified On: |
27/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial To Know The Effect of Karanj Taila In The Management of Otomycosis |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Effect of Karanj Taila in the Management of Otomycosis. |
| Trial Acronym |
|
|
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 |
Reader, P.G Deptt. of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola |
| Address |
Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola
Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayant Bhardwaj |
| Designation |
Reader, P.G Deptt. of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola |
| Address |
Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola
Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalita Devi |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola |
| Address |
Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola
Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018370926 |
| Fax |
|
| Email |
lalitathakur17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy |
| Charak Pharmacy, RGGGPG Ayurvedic College And Hospital Paprola, Distt Kangra, H.P |
| Research Institute in I.S.M Jogindernagar, Distt Mandi, H.P |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic college and hospital paprola |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola, Distt Kangra, Pin Code - 176115, H.P |
| 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 Vijayant Bhardwaj |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital Paprola |
OPD No. 201 Rajiv Gandhi Government Post Graduate Ayurvedic Hospital Block, Paprola, Distt Kangra H.P
Kangra
HIMACHAL PRADESH |
9418017568
bhardwajvijayant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (Human) RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H603||Other infective otitis externa. Ayurveda Condition: KARNA-KANDU, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Clotrimazole | 2 drops of clotrimazole 1% thrice daily will be instilled in external auditory canal for 15 days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: karanj taila, Reference: Database of CCRAS vol 2, Route: Otic, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: 1 ml of Karanj tail will be instilled in external auditory canal twice a day for 5 minutes |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be selected from OPD/IPD RGGPG Ayurvedic College Paprola irrespective of age, sex, and disease. |
|
| ExclusionCriteria |
| Details |
Ruptured Tympanic membrane. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Karanj tail in otomycosis.
Alleviation of symptoms like itching, pain in ear, ear discharge, blockage in ear and fungal mass will be assessed. |
2 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Generate feeling of wellbeing. |
2 weeks |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/11/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
I would like to publish my research work after the completion of the trial as soon as possible. Patients will be selected from OPD/IPD of RGGPG Ayurvedic College and Hospital Paprola.Two groups of 30 patients will be registered as assessed to evaluate the effect of karanj tail in the management of Otomycosis. |