| CTRI Number |
CTRI/2024/08/072858 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluate the effect of Nirgundyadi Taila and Rasnadi Guggulu in the management of Tinnitus. |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Nirgundyadi Taila and Rasnaadi Guggulu in the management of Karna Naad w.s.r. to Tinnitus. |
| 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 and Professor Shalakya Tantra Department |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Room no 213 PG Department of Shalakya Tantra Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayant Bhardwaj |
| Designation |
HOD and Professor Shalakya Tantra Department |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Room no 213 PG Department of Shalakya Tantra Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra Himachal Pradesh 176115
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Kamal |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
Opd no.201, Shalakya Tantra Department Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Distt Kangra Himachal Pradesh 176115 India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8628863228 |
| Fax |
|
| Email |
Kamalpoonam45@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital,Paprola, Kangra, H.P. 176115 India Baijnath Pharmacy Paprola, Distt. Kangra, H.P. 176115 India Research Institute in I.S.S.M. Jogindernagar Distt. Mandi, H.P. 175015 India |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra Himachal Pradesh 176115 |
| 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 Government Post Graduate Ayurvedic College and Hospital Paprola |
Opd no.201,Department of Shalakya Tantra,Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra H.P.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 Commitee (Human)Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Distt. Kangra H.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H931||Tinnitus. Ayurveda Condition: KARNA-NADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | karNapUraNam, करà¥à¤£à¤ªà¥‚रणमॠ| (Procedure Reference: Sharangdhar samhita uttar khand 11/128, Procedure details: Karan pooran with 2ml Nirgundyadi Taila in each ear twice a day for 15 days.)
(1) Medicine Name: Nirgundyadi Taila, Reference: Yog ratnakar karna rog adhikar, Route: Otic, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Duration: 15 Days(2) Medicine Name: Rasnaadi guggulu, Reference: Bharat bhaishajya ratnakar /chaturath bhag, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: tds, Duration: 15 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasnaadi Guggulu , Reference: Bharat bhaishajya ratnakar/chaturth bhag, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to undergo trial.
The patient with symptoms of subjective type of Tinnitus of Karna Naad as described in Ayurvedic and Modern literature attending the OPD of department of Shalakya R.G.G.P.G.Ayurvedic College and Hospital Paprola |
|
| ExclusionCriteria |
| Details |
Diabetes Mellitus,Hypertension,Hypotension,Hyperthyroidism,Hypothyroidism,Hyperlipidemia,Acute suppurative otitis media,Adhesive otitis media,Meniere disease,Otitis media with effusion,Auto immune disorders and surgical management. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Tinnitus. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Karna Naad w.s.r to Tinnitus |
15 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)
|
10/09/2024 |
| 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="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 he trial as soon as possible.Patients will be selected from OPD/IPD of RGGPG Ayurvedic College and Hospital Paprola.3 groups of 30 patients will be registered as assessed to evaluate evaluate the effect of Nirgundyadi Taila and Rasnaadi guggulu in the management of Karna Naad w.s.r. to Tinnitus. |