| CTRI Number |
CTRI/2025/08/093461 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| 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
|
Effect of Yavadi Karnadhoopana along with Rasnadi Guggulu in Chronic Ear Discharge |
|
Scientific Title of Study
|
Randomized open labelled controlled clinical study Of Yavadi Karnadhoopana along with Rasnadi Guggulu given systemically in
Pootikarna with special reference 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 |
Swetha Laxminarayana Vemula |
| Designation |
PG Student |
| Affiliation |
Government Ayurved College,Nanded |
| Address |
Government Ayurved College and Hospital Vazirabad Nanded Maharashtra India
Government Ayurved College and Hospital Vazirabad Nanded Maharashtra India
Nanded
MAHARASHTRA
431601
India |
| Phone |
09765762853 |
| Fax |
|
| Email |
swetha.vemula97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Shamrao Wakode |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College,Nanded |
| Address |
Government Ayurved College and Hospital Vazirabad Nanded Maharashtra India
Nanded
MAHARASHTRA
431601
India |
| Phone |
9421757613 |
| Fax |
|
| Email |
kalpanawakode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Shamrao Wakode |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College,Nanded |
| Address |
Government Ayurved College and Hospital Vazirabad Nanded Maharashtra India
Nanded
MAHARASHTRA
431601
India |
| Phone |
9421757613 |
| Fax |
|
| Email |
kalpanawakode@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalakyatantra Department Government Ayurved College Vazirabad Nanded 431601 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Swetha Laxminarayana Vemula |
| Address |
Shalakyatantra Department Government Ayurved College Vazirabad Nanded 431601 Maharashtra India |
| 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 Swetha Laxminarayana Vemula |
Government Ayurved College and Hospital Nanded |
OPD No 24 Shalakyatantra Department Government Ayurved College and Hospital Vazirabad Nanded Maharashtra India
Nanded
MAHARASHTRA |
9765762853
swetha.vemula97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurved College Nanded |
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: PUTIKARNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 36 karNadhUpanam | (Procedure Reference: 36 karNadhUpanam, Procedure details: Dhoomavarti of Yava Agaru Madanphala is ignited and fumes are passed through a tube or conical shaped paper to external ear for 10 minutes Pratah kal for 15 days)
(1) Medicine Name: Rasnadi Guggulu, Reference: Yogaratnakara Uttarardha Karnaroga Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | 36 karNadhUpanam | (Procedure Reference: 36 karNadhUpanam, Procedure details: Guggulu ignited and fumes are passed through a tube or conical shaped paper to external ear for 10 minutes)
(1) Medicine Name: Rasnadi Guggulu, Reference: Yogaratnakar Uttarardha Karnaroga Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having tubotympanic or benign type of Chronic suppurative otitis media without complications
Patient willing for treatment |
|
| ExclusionCriteria |
| Details |
Patient showing features of atticoantral type of Chronic suppurative otitis media
Posterio Superior marginal attic perforation of tympanic membrane
Patient with congenital deformity
Acute otitis media
Ear Malignancy Aural polyp
Patients with cholesteatoma
Patients having blockage due to stenosis of external auditory canal
Having history of middle ear or mastoid surgery
Disease other than ear pathology like CSF fluid otorrhoea parotid abscess rupturing in external auditory canal temperomandibular joint abscess rupture in external auditory canal
Patients with other uncontrolled severe systemic infectious diseases
Patients with cardiac renal or hepatic impairment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased Ear Discharge |
Before Treatment Day 0
After Treatment Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
04/09/2025 |
| 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="3"
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
|
Chronic Suppurative Otitis Media is the most common infectious disease of the ear Satisfactory Treatment is unavailable Trail Drug is Guggulu Karnadhoopana with Rasnadi Guggulu given systemically and Control Drug is Yavadi Karnadhoopana with Rasnadi Guggulu given systemically for CSOM Both Experimental and Control groups are studied irrespectively Observation and Conclusions are drawn from Statistical tests for significance
|