| CTRI Number |
CTRI/2025/04/085979 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Ayurveda Intervention (Karnapurana Therapy)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study the Effect of Karnapurana in the Patient of Tinnitus |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Therapeutic Effect Of Karnapurana With Lashun Siddha Moorchit Sarshap Tail And Moorchit Sarshap Tail In 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 Harshal Patil |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda and Research, Parul University, Vadodara, Gujarat |
| Address |
2nd floor,Department of ShalakyaTantra, Parul Institute of Ayurveda and Research, Parul University,P.O. Limda, Tal- Waghodia, Dist-Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
7020555354 |
| Fax |
|
| Email |
dr.harshalgurjar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Tejasvi S |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda and Research, Parul University, Vadodara, Gujarat |
| Address |
2nd floor,Department of ShalakyaTantra, Parul Institute of Ayurveda and Research, Parul University,P.O. Limda, Tal- Waghodia, Dist-Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9164774710 |
| Fax |
|
| Email |
ganesh.s36117@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Tejasvi S |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda and Research, Parul University, Vadodara, Gujarat |
| Address |
2nd floor,Department of ShalakyaTantra, Parul Institute of Ayurveda and Research, Parul University,P.O. Limda, Tal- Waghodia, Dist-Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9164774710 |
| Fax |
|
| Email |
ganesh.s36117@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Dr Harshal Patil, Post Graduate Scholar, Department of ShalakyaTantra, Parul Institute of Ayurved and Research Parul University,Ishwarpura, P.O. Limda Vadodara Gujarat India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurveda And Research |
| Address |
Parul Institute of Ayurveda and Research, Parul University,P.O. Limda, Tal- Waghodia, Dist-vadodara, Gujarat,India 391760 |
| 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 Harshal Patil |
KHEMDAS HOSPITAL |
OPD No: -3, Department of Shalakyatantra ,ENT OPD, Ground Floor, Ishwarpura, P.O. Limda, Tal- Waghodia, Dist-Vadodara, Gujarat India 391760
Vadodara
GUJARAT |
7020555354
dr.harshalgurjar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H833||Noise effects on inner ear. Ayurveda Condition: KARNA-NADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | karNapUraNam, कर्णपूरणम् | (Procedure Reference: Ashtang Hridaya Sutra Sthana 22/32, Procedure details: patient will be made to lie down on lateral position depending on affected side. Gentle massage with luke warm oil and mild hot fomentation around the ear will be done. Warm medicated oil will be poured in drops. The root of ear should be gently massaged. The medicated oil should be retain in same position for 100 matra.) , Route: Otic, Dosage Form: Tail, Frequency: once in a day.)
(1) Medicine Name: Lashun Siddha Moorchit Sarshap Tail, Reference: Other than Classical, Route: Otic, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | karNapUraNam, कर्णपूरणम् | (Procedure Reference: Ashtang Hridaya Sutra Sthana 22/32, Procedure details: patient will be made to lie down on lateral position depending on affected side. Gentle massage with luke warm oil and mild hot fomentation around the ear will be done. Warm medicated oil will be poured in drops. The root of ear should be gently massaged. The medicated oil should be retain in same position for 100 matra.) , Route: Otic, Dosage Form: Taila, Frequency: once in a day.)
(1) Medicine Name: Moorchit Sarshap Tail, Reference: Bhaishajyaratnavali 62|25,Kaviraj Shri Ambikadattashastri Ayurvedacharya, Hindi translation, page no.979, Chaukhamba Surbharati Prakashan, Varanasi, Reprint edition,2017., Route: Otic, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-75 years.
Clinical diagnosis of subjective tinnitus.
Participants with moderate to severe tinnitus as assessed by a validated tinnitus severity scale (Tinnitus Handicap Inventory, Tinnitus Functional Index).
Stable general health with no acute systemic illness or active ear infections.
Absence of prior ear surgery or invasive procedures affecting auditory function.
Absence of known allergy to garlic or mustard to ensure safety of oil application.
Willing and able to comply with study procedures and follow-up visits. |
|
| ExclusionCriteria |
| Details |
Objective tinnitus or structural auditory abnormalities.
Severe otological or neurological disorders.
Current use of tinnitus-altering medications.
Significant psychiatric disorders.
Pregnancy or lactation.
Ear infections or inflammation.
Allergies to intervention.
Other medical or social factors impacting participation.
Tinnitus from earwax, foreign bodies, or tympanic membrane rupture. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduces the severity of tinnitus. |
0-15 days
BT-0th Day
DT-7th Day
AT-15th Day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Tinnitus Severity (Subjective Perception),Quality of Life,Changes in Sleep Quality,Reduction in Anxiety and Depression Symptoms,Etc. |
0-15 days
BT-0th Day
DT-7th Day
AT-15th Day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/06/2025 |
| 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="6"
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 study aims to compare the therapeutic effects of Karnapurana with Lashun Siddha Moorchit Sarshap Tail and Moorchit Sarshap Tail in the treatment of Karnanada (tinnitus). It is a randomized controlled trial involving adults with moderate to severe subjective tinnitus. The primary outcome will be the reduction in tinnitus severity, assessed using the Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI). Secondary outcomes include quality of life, sleep quality, anxiety and depression levels, and safety monitoring. Follow-up evaluations will assess both the efficacy and safety of the treatments. |