| CTRI Number |
CTRI/2025/02/080803 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the effect of Laxmivilas Rasa and Madhyam Narayan Taila Karnapuran in the management of Conductive Hearing Loss and Sensorineural Hearing Loss.
|
|
Scientific Title of Study
|
A comparative study to evaluate the effect of Laxmivilas Rasa and Madhyam Narayan Taila Karnapuran in the management of Conductive Hearing Loss and Sensorineural Hearing Loss. |
| 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
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nihar Jetly |
| Designation |
PG scholar |
| Affiliation |
Rajiv Gandhi Govrnment Post Graduate Ayurvedic College and Hospital |
| 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 |
8104871798 |
| Fax |
|
| Email |
jetlynihar204@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola, Kangra, H.P. 176115 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital |
| Address |
Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
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 |
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 |
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 Kangra HIMACHAL PRADESH 176115 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H60-H95||Diseases of the ear and mastoid process. Ayurveda Condition: BADHIRYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Laxmivilas Rasa , Reference: Bhaisajya Kalpna Rasayan Adhikar 55, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Millk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing and able to participate in the trial.
Patient presenting with signs and Symptoms of sensorineural and conductive hearing loss
Patients of above 5years and below 60 years age will be selected.
|
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the trial.
Patients suffering from other ear pathologies like tumours, trauma of External Auditory Canal etc.
Patients above 60 years and below 5 years old.
Patient suffering from malnutrition. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Conductive and Sensorineural Hearing Loss in patient |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the the clinical safety of Laxmivilas Rasa and Madhyam Narayan Taila in the management of Conductive Hearing loss and Sensorineural Hearing Loss. |
30 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
14/03/2025 |
| 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="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 the effect of Laxmivilas Rasa and Madhyam Narayan Taila Karnapuran in the management of Conductive Hearing Loss and Sensorineural Hearing Loss |