| CTRI Number |
CTRI/2024/05/067960 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| 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
|
TO EVALUATE EFFICACY OF SHATADHAUTA GHRITA KARNAPICHU IN THE MANAGEMENT OF PITTAJA KARNASHULA WITH SPECIAL REFERENCE TO OTITIS EXTERNA |
|
Scientific Title of Study
|
A randomized open label controlled clinical study to evaluate the efficacy of Shatadhauta Ghrita Karnapichu in the management of Pittaja Karnashula with special reference to Otitis Externa |
| 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 Shivani C Kottur |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Room number 305 Department of PG Studies in Shalakyatantra Sri
Sri College of Ayurvedic Science and Research Hospital 21st KM
Kanakapura main road Udayapura post Bengaluru 560082
KARNATAKA
560082
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
7892780168 |
| Fax |
|
| Email |
ckshivani18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha Kumari B |
| Designation |
Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Room number 305 Department of PG Studies in Shalakyatantra Sri
Sri College of Ayurvedic Science and Research Hospital 21st KM
Kanakapura main road Udayapura post Bengaluru 560082
KARNATAKA
560082
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9480056218 |
| Fax |
|
| Email |
ayurgeeta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha Kumari B |
| Designation |
Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Room number 305 Department of PG Studies in Shalakyatantra Sri
Sri College of Ayurvedic Science and Research Hospital 21st KM
Kanakapura main road Udayapura post Bengaluru 560082
KARNATAKA
560082
KARNATAKA
560082
India |
| Phone |
9480056218 |
| Fax |
|
| Email |
ayurgeeta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital
21st KM kanakapura main road Udayapura post Bengaluru, Karnataka 560082
|
|
|
Primary Sponsor
|
| Name |
Dr Shivani C Kottur |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital 21st KM
Kanakapura main road Udayapura post Bengaluru 560082
KARNATAKA
560082 |
| 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 Shivani C Kottur |
Sri Sri college Of Ayurvedic Science And Research Hospital |
Room number 305 Department of PG Studies in Shalakyatantra Sri
Sri College of Ayurvedic Science and Research Hospital 21st KM
Kanakapura main road Udayapura post Bengaluru 560082
KARNATAKA
560082
Bangalore Rural
KARNATAKA |
7892780168
ckshivani18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H609||Unspecified otitis externa. Ayurveda Condition: KARNASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatadhauta Ghrita, Reference: Sushruta Uttara tantra 39/283, Route: Topical, Dosage Form: Ghrita, Dose: 6(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: A sterile gauze piece will be smeared with Shatadhauta Ghrita and placed in the External Auditory Canal with all aseptic precautions | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu Ghrita, Reference: Ashtanga Hridaya Uttara tantra 18/7, Route: Topical, Dosage Form: Ghrita, Dose: 6(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: A sterile gauze piece will be smeared with Yashtimadhu Ghrita and placed in the External Auditory Canal with all aseptic precautions |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects within the age of 21-40 years irrespective of gender, occupation, religion, socio- economic status and duration of illness.
2.Subjects fulfilling the diagnostic criteria.
3.Subjects willing to undergo trial and sign the informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Subjects diagnosed with disorders of auricle.
2.Subjects diagnosed with infective cases of the tympanic membrane and middle ear like acute suppurative otitis media, active stage of chronic suppurative otitis media.
3.Subjects diagnosed with cholesteatoma.
4.Subjects with uncontrolled systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Significant improvement in the signs and symptoms of Pittaja Karnashoola.
2.Significant improvement in the signs and symptoms of Otitis externa.
|
Pre-assessment- 0th day
Post-assessment- 6th day
1st follow up- 14th day
2nd follow up-21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Generation of in - depth analysed data on the different aspect of the disease.
2.Generation of data on possible unexpected drug reaction.
|
Pre-assessment- 0th day
Post-assessment- 6th day
1st follow up- 14th day
2nd follow up-21st day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
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
Modification(s)
|
Pittaja Karnashoola is
one such condition where vitiation of Pitta and Vata is
seen, which causes severe pain and is intolerable to an individual.
The symptoms
of Pittaja Karnashoola can be considered as an inflammatory
disorder of the external ear, Otitis externa.
The prevalence of the condition
Otitis externa is 17.5% in the developing countries. Also, it has a
lifetime prevalence of 10% and can arise in acute, chronic or necrotizing
forms.
It is common all over the world
with higher incidence in tropical than in temperate zones. Most commonly it
affects adults. The incidence is increased fivefold in swimmers; thus, this
condition is also called as swimmer’s ear.
In contemporary science, the
treatment of Otitis externa includes systemic antibiotics, analgesics and an
aural pack with 10% ichthammol glycerine or with steroid
antibiotic.
In Ayurveda, Karnapoorana has
been mentioned as one of the treatment modality
in Pittaja Karnashoola with Pittahara Dravyas.
RESEARCH QUESTION:
•Whether Shatadhauta Ghrita Karnapichu is
effective in the management
of Pittaja Karnashoola w.s.r to Otitis externa?
HYPOTHESIS:
Null Hypothesis (H0): There is
no significant difference
between Shatadhauta Ghrita Karnapichu and Yashtimadhu Ghrita Karnapichu in
the management of Pittaja Karnashoola w.s.r to Otitis
externa.
Alternative Hypothesis (H1): Efficacy
of Shatadhauta Ghrita Karnapichu is more effective than
that of Yashtimadhu Ghrita Karnapichu in the management
of Pittaja Karnashoola w.s.r to Otitis externa.
Alternative Hypothesis (H2): Efficacy
of Yashtimadhu Ghrita Karnapichu is more effective than
that of Shatadhauta Ghrita Karnapichu in the management
of Pittaja Karnashoola w.s.r to Otitis externa.
|