| CTRI Number |
CTRI/2025/02/081364 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial To Compare Effectiveness of Hingvadi Taila Karnapurana (filling ear with medicated oil) and Rasnadi Guggulu orally in Karnanada (Tinnitus). |
|
Scientific Title of Study
|
A Randomized Clinical Trial To Evaluate The Efficacy Of Hingvadi Taila Karnapurana With and Without Rasnadi Guggulu Orally In The Management Of Karnanada 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 Arvind Sharma |
| Designation |
M.S. Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India |
| Address |
OPD no. 9 and 10, PG Dept. of Shalakya Tantra,
Madan Mohan Malviya Government Ayurved College,Near Radaji Circle, Udaipur, Rajasthan(313001), India
OPD no. 9 and 10, PG Dept. of Shalakya Tantra,
Madan Mohan Malviya Government Ayurved College Near Radaji Circle, Ambamata, Udaipur, Rajasthan(313001), India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413583528 |
| Fax |
|
| Email |
healthfirst.as03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gulab Chand Bairwa |
| Designation |
Professor & HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India |
| Address |
OPD no. 9 and 10, PG Dept. of Shalakya Tantra,
Madan Mohan Malviya Government Ayurved College Near Radaji Circle,Udaipur, Rajasthan(313001), India
OPD no. 9 and 10, PG Dept. of Shalakya Tantra,
Madan Mohan Malviya Government Ayurved College Near Radaji Circle, Ambamata, Udaipur, Rajasthan(313001), India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460353407 |
| Fax |
|
| Email |
bairwaboss75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulab Chand Bairwa |
| Designation |
Professor & HOD |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
OPD no. 9 and 10, PG Dept. of Shalakya Tantra,
Madan Mohan Malviya Government Ayurved College Near Radaji Circle, Udaipur, Rajasthan(313001), India
OPD no. 9 and 10, PG Dept. of Shalakya Tantra,
Madan Mohan Malviya Government Ayurved College Near Radaji Circle, Ambamata, Udaipur, Rajasthan(313001), India
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460353407 |
| Fax |
|
| Email |
bairwaboss75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan |
| 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 Arvind Sharma |
Madan Mohan Malviya Government Ayurved College and Hospital, Udaipur |
O.P.D. No. 9 & 10, P.G. Department Of Shalakya Tantra.
Madan Mohan Malviya Government Ayurved College, Udaipur(313001), Rajasthan, India
Udaipur
RAJASTHAN |
9413583528
healthfirst.as03@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE M.M.M. Govt. Ayurved College Ambamata Udaipur |
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: KARNA-NADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasnadi Guggulu, Reference: Yoga Ratnakar Karnaroga Chikitsa/78, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Luke warm Water), Additional Information: - | | 2 | Comparator Arm | Procedure | - | karNapUraNam, कर्णपूरणम् | (Procedure Reference: Sharandhara Samhita / Uttar khand/ chapter 11/ shloka no. 126, Procedure details: Filling of ear with medicated oil)
(1) Medicine Name: Higvadi tail, Reference: Gada Nigraha / Tritya shalakyadi-panchakarmaadhikaraanto bhagha 2 / shloka 43, Route: Otic, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients pertaining symptom of Karnanada irespective of gender, caste and religion and occupation.
2.Patients in age group of 20 to 80 year with intact and Normal Tympanic Membrane. |
|
| ExclusionCriteria |
| Details |
1.Congenital deformity
2.Patients of Otosclerosis and fluid in the middle ear
3.Blockage due to stenosis of external auditory canal/wax 4.Pregnant, Immuno Compromised patients
5.Tinnitus due to non Otolgic factors (Diabetes Mellitus, Hypertension, Thyroid disease etc.) and Glomus Tumor, Aneurysm of Carotid Artery, Palatal Myoclonus and Tumor of Auditory Nerve. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Karnanada w.s.r. to Tinnitis |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in other associated symptoms. |
15th day and 30th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2025 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This is a clinical trial to compare efficacy of Hingvadi Taila Karnapurna and Rasnadi Guggulu on Karnanada with special reference to Tinnitus. In this trial 2 groups
each of 30 patients will be selected. Group A will be administered with Hingvadi Taila Karnapurna and oral administration of Rasnadi Guggulu Vati 2 BD with lukewarm water. Group B will be administered
with Hingvadi Taila Karnapurna only. |