| CTRI Number |
CTRI/2025/07/091100 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study Of Samudraphena Powder Dusting In Ear Followed By Kshoumadi Fumigation And Ajamutra Arka Mopping In Ear Followed By Agaru Fumigation For Ear Discharge |
|
Scientific Title of Study
|
an open label double arm randomized comparative clinical study to evaluate the efficacy of Samudraphena avachurnana followed by Kshoumadi dhupana and Ajamutra arka karnapramarjana followed by Agaru dhupana in Karnasrava w.s.r to chronic suppurative otitis media |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrHarsha Vardhan Reddy |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri kalabyraveswara swamy ayurvedic medical college hospital and research centre |
| Address |
OPD NO:-21
department of shalakya tantra
sri kalabyraveswara swamy ayurvedic medical college hospital and research centre 10 pipeline road rpc layout vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
8885610218 |
| Fax |
|
| Email |
drharshareddypg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujathamma K |
| Designation |
Professor |
| Affiliation |
Sri kalabyraveswara swamy ayurvedic medical college hospital and research centre |
| Address |
Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore 560104
Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9448848786 |
| Fax |
|
| Email |
drsujathammaskamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujathamma K |
| Designation |
Professor |
| Affiliation |
Sri kalabyraveswara swamy ayurvedic medical college hospital and research centre |
| Address |
Room no 21 Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore 560104
Dept Of PG Studies In Shalakya Tantra Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
9448848786 |
| Fax |
|
| Email |
drsujathammaskamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Harsha Vardhan Reddy
Room No 21 Dept Of Pg Studies In Shalakya Tantra
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore Karnataka India 560104
|
|
|
Primary Sponsor
|
| Name |
Dr Harsha Vardhan Reddy |
| Address |
Room No 21 Dept Of Pg Studies In Shalakya Tantra
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Reseach Centre Vijayanagar Bangalore Karnataka India 560104
|
| Type of Sponsor |
Other [Dr.Harsha Vardhan Reddy] |
|
|
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 Kiran M Goud |
Sri kalabyraveswara swamy ayurvedic medical college hospital and research centre |
Sri kalabyraveswara swamy ayurvedic medical college hospital and research centre banglore 10 pipeline road rpc layout Vijayanagar Bangalore
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Skamc rc |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H661||Chronic tubotympanic suppurative otitis media. Ayurveda Condition: KARNA-SRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | dhUpana, धूपन | (Procedure Reference: Kurnaguta roga Pratishedhu Adhyaya of Sushruta Samhita, Procedure details: Dhoopana is a technique of fumigation of
the ear with the smoke of medicated drugs)
(1) Medicine Name: agaru, Reference: Sushruta Samhita , Route: Otic, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | avacUrNan , अवचूर्णन | (Procedure Reference: Basavarajeeyam, Procedure details: Avachurnana is procedure of dusting the medicated fine
powder )
(1) Medicine Name: Samudraphena , Reference: Basavarajeeyam, Route: Otic, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Duration: 7 Days | | 3 | Intervention Arm | Procedure | - | dhUpana, धूपन | (Procedure Reference: Sushruta Samhita, Procedure details: Dhoopana is a technique of fumigation of
the ear with the smoke of medicated drugs)
(1) Medicine Name: Kshoumadi , Reference: Sushruta samhita, Route: Otic, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 7 Days | | 4 | Comparator Arm | Procedure | - | pramArjana-karma, प्रमार्जन-कर्म | (Procedure Reference: Basavarajeeyam, Procedure details: Pramarjana is procedure of cleaning ear with the help of
cotton or gauze piece soaked in oil or other antiseptic decoction of drug.)
(1) Medicine Name: Ajamutra arka, Reference: Basavarajeeyam, Route: Otic, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with the lakshanas of karnasrava.
Subjects within the age group of 10-60 years of either gender.
Subjects with mucoid, mucopurulent or purulent ear discharge of non-foetid odour
Subjects with chronic suppurative otitis media (tubo tympanic type)
Subjects with mild to moderate conductive hearing loss. |
|
| ExclusionCriteria |
| Details |
Subjects with Attico antral tympanic perforation
Subjects with blood-stained ear discharge.
Subjects with severe conductive, sensory-neural and mixed hearing.
Subjects with h/o CSF otorrhea, cholesteatoma
Subjects with h/o head injury, temporal and cranial infections
Subjects with other systemic diseases which interferes during treatment
Pregnant women and lactating mothers.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check the cessation of karnasrava with ajamutra arka karnapramarjana followed by agaru dhupana and samudraphena avachurnana followed by kshoumadi dhupana w.s.r chronic suppurative otitis media
|
total duration of study 14 days avachurnana and karna dhupana will be done for 7 days follow up after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
07/05/2026 |
| 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="2"
Months="1"
Days="1" |
|
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
|
To overcome the complications and to evaluate the treatment modalities with good results, Ayurvedic classics describe Sthanika Upakrama to treat Karnagata rogas in a simple and effective way. Acharva Sushruta has mentioned Karna Dhoopana, the book Basavarajeeyam has mentioned avachurnana as treatment modalities for Karnasrava. Karna dhoopana is a technique of fumigation of the ear with the smoke of medicated drugs. Avachurnana is procedure of dusting the medicated fine powder into the external auditory canal. Karna Pramarjana is procedure of cleaning ear with the help of cotton or gauze piece soaked in oil or other antiseptic decoction of drug. In the present study, Samudraphena Churna, which is known for its lekhana and shodhana properties, is used for dusting into the ear to arrest srava and promote healing, Kshoumadi Dhupana which contains kshouma, agaru, and guggulu provide actions through local dhupana. Karnapramarjana with ajamutra arka is having properties of shoshana guna along with krimihara and shothahara followed by agaru dhupana in karna helps in drying out the excess moisture through its ushna guna and it also possess krimighna and shothahara property’". Hence, the present study aims to compare the effects of Samudraphena avachurnana followed by kshoumadi dhupana and ajamutra arka karnapramarjana followed by agaru dhupana is used in Karna Srava, w.s.r. chronic suppurative otitis media. |