| CTRI Number |
CTRI/2025/07/091313 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial of Swarjikadi Taila and Sarivadi Vati in Tinnitus |
|
Scientific Title of Study
|
Effect of Swarjikadi Taila Karnapoorana and Sarivadi Vati orally in management of Karnanada with special reference to Tinnitus a randomixed controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Sawant |
| Designation |
PG Scholar |
| Affiliation |
KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre |
| Address |
Department of Shalakyatantra OPD No 26 and 27 KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
9552486176 |
| Fax |
|
| Email |
ankitasawant91098@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalmesh Sangolli |
| Designation |
Professor |
| Affiliation |
KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre |
| Address |
Department of Shalakyatantra OPD No 26 KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
9448266969 |
| Fax |
|
| Email |
drksskle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalmesh Sangolli |
| Designation |
Professor |
| Affiliation |
KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre |
| Address |
Department of Shalakyatantra OPD No 26 KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahapur
KARNATAKA
590003
India |
| Phone |
9448266969 |
| Fax |
|
| Email |
drksskle@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra Kankayan OPD No 26 KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahapur Belgavi Karnataka 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Sawant |
| Address |
Department of Shalakyatantra OPD No 26 and 27 KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahapur |
| Type of Sponsor |
Other [Self] |
|
|
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 Ankita Sawant |
KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre |
Department of Shalakyatantra OPD No 26 and 27 KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahapur
Belgaum
KARNATAKA |
09552486176
ankitasawant91098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee for research on human subjects |
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 | Drug | Classical | | (1) Medicine Name: Apamarga Kshar Taila, Reference: DAS G BHAISAJHYA RATNAVALI 2009th ed Vol III K 37/116 Gopal Mandir Lane Golghar Varanasi 221001 CHAUKHAMBHA SANSKRIT SANSTHAN 2009, Route: Otic, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Sarivadi Vati, Reference: DAS G BHAISAJHYA RATNAVALI 2009th ed Vol III K 37/116 Gopal Mandir Lane Golghar Varanasi 221001 CHAUKHAMBHA SANSKRIT SANSTHAN 2009, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Koshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Swarjikadi Taila, Reference: DAS G BHAISAJHYA RATNAVALI 2009th ed Vol III K 37/116 Gopal Mandir Lane Golghar Varanasi 221001 CHAUKHAMBHA SANSKRIT SANSTHAN 2009, Route: Otic, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Sarivadi Vati, Reference: DAS G BHAISAJHYA RATNAVALI 2009th ed Vol III K 37/116 Gopal Mandir Lane Golghar Varanasi 221001 CHAUKHAMBHA SANSKRIT SANSTHAN 2009, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with sound in ear like bheri mrudanga shankha
Roaring hissing swishing rustling or clicking type of noise
Irrespective of socio economic status caste and religion will be taken
Subjects who are fit for Karnapoorna
|
|
| ExclusionCriteria |
| Details |
Congenital deformity of ear
Daignosed cases of Aneurysm and arteriovenous shunt around the ear
Blockage of external auditory canal due to wax or foreign body and perforation of tympanic membrane
Daignosed cases of Intracranial vascular tumors and glomus tumors
Cases of uncontrolled diabetes mellitus and hypertension
Subjects not willing to be registered for the trial
Subjects which required surgical intervention related with ENT
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate effect of Swarjikadi Taila Karnapoorana and Sarivadi Vati orally in management of Karna Nada w.s.r to Tinnitus |
DAY 0th(Before Treatment)
DAY 8th(After Treatment)
DAY 30th(Follow UP)
DAY 45th(Follow UP) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Swarjikadi Taila Karnapoorana & Sarivadi Vati with Apamarga Kshara Taila Karnapoorana & Sarivadi Vati in the management of Karna Nada w s r to Tinnitus |
0th day
8th day
30th day
45th day |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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 4 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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) |
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
|
NEED FOR THE STUDY
Tinnitus is defined as a phantom auditory perception
Studies have reported
highly variable tinnitus prevalence ranging from 4 percent to 37 percent
worldwide
Mild sedative
antidepressants vasodilators carbamazepine vitamins with anti oxidants have
been tried with varying results it can
be treated by treating comorbidities such as hearing impairment depression insomnia and anxiety
Tinnitus Retraining Therapy Counselling Sound therapy
Tinnitus masker are some of the non pharmacological treatments used
In TRT tinnitus habituation is created
With this therapy patients suffering from tinnitus lose
awareness of tinnitus and also do not get annoyed even when they do have
tinnitus
TRT needs a long period of 18 to 24 months
The long term effect of TRT is not well known and outcome
evaluation can take up to 1 to 2 years
A number of options have been used to treat patients with
tinnitus but outcomes have been limited So ayurvedic approach will provide a
turning point in the management of tinnitus as no absolute cure is there for
tinnitus
Disease Review
KARNANADA
Acharya Sushruta has explained twenty eight types of Karna
Rogas and KaranaNada is one of them
Vitiated vata dosha
either entering into other channels or encircled by kaphadi doshas in sabdavaha
srotas produces different types of sounds in the ear like bheri mrudanga
shankha etc is known as Karna Nada
The clinical features
of Karna Nada relates to Tinnitus in modern science
TINNITUS
Tinnitus is an auditory sensation within the ears or head in
the absence of any relevant external stimulus to cause it
It may vary in pitch and loudness and has been variously
described by the patient as roaring hissing swishing rustling or clicking type
of noise
Tinnitus is more
annoying in quiet surroundings particularly at night when the masking effect of
ambient noise from the environment is lost
TYPES OF TINNITUS
Two types of tinnitus are described
1 Subjective which can only be heard by the patient
2 Objective which can even be heard by the examiner
AIM
Effect of Swarjikadi Taila Karnapoorana and Sarivadi
vati orally in Management of Karna Nada with special reference to
Tinnitus
OBJECTIVES
Primary To evaluate
Effect of Swarjikadi Taila Karnapoorana and Sarivadi Vati orally
in management of Karna Nada with special reference to Tinnitus
SECONDARY To compare the effect of Swarjikadi
Taila Karnapoorana and Sarivadi Vati with Apamarga Kshara Taila
Karnapoorana and Sarivadi Vati in the management of Karna Nada
with special reference to Tinnitus
RESEARCH QUESTION
Is Swarjikadi Taila Karnapoorana and Sarivadi Vati
orally effective in the management of Karna Nada w.s.r to tinnitus when
administered for period of 7 days
HYPOTHESIS
H0 Swarjikadi Taila Karnapoorana and Sarivadi
Vati orally is not comparable to Apamarga Kshara Taila Karnapoorana
and Sarivadi Vati orally in the management of Karna Nada with special
reference to tinnitus
H1 Swarjikadi Taila Karnapoorana and Sarivadi
Vati orally is comparable to Apamarga Kshara Taila Karnapoorana and Sarivadi
Vati orally in the management of Karna Nada with special reference
to tinnitus
Expected Outcome
Swarjikadi Taila Karnapoorana and Sarivadi Vati
orally if proved effective will help in reducing the symptoms of Karna Nada with
special reference to Tinnitus |