| CTRI Number |
CTRI/2019/07/020097 [Registered on: 09/07/2019] Trial Registered Prospectively |
| Last Modified On: |
22/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of certain ayurvedic drugs given by oral and topical(ear)route in the management of ear discharge |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL TRIAL ON COMPARATIVE EFFICACY OF PRIYANGVADI TAILA KARNAPICHU AND LAKSHADI AVCHURNAN ALONG WITH BHAIRAVA RASA ORALLY IN THE MANAGEMENT OF KARNASRAVA W.S.R. TO CHRONIC SUPPURATIVE OTITIS MEDIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shamsa Fiaz |
| Designation |
Professor & HOD |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Shalakya Tantra,National Institute of
Ayurveda,Jorawar Singh Gate,Amer Road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shamsa Fiaz |
| Designation |
Professor & HOD |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Shalakya Tantra,National Institute of
Ayurveda,Jorawar Singh Gate,Amer Road,Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shamsa Fiaz |
| Designation |
Professor & HOD |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Shalakya Tantra,National Institute of
Ayurveda,Jorawar Singh Gate,Amer Road,Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,Jaipur,Rajasthan,302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
P.G. Department of Shalakya Tantra,National Institute of
Ayurveda,Jaipur |
| 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 |
| Vd Sheenam |
National Institute of Ayurveda |
OPD no.13 P.G. Department of
Shalakya Tantra
Jaipur
RAJASTHAN |
9461261333
vdsheenam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lakshadi Avachurnan and Bhairava Rasa. |
Lakshadi Churna- Quantity held in Avachurnan (1-3gm) once a day 45days.
Bhairava Rasa 125 – 250 mg twice a day with honey for 45 days. |
| Intervention |
Priyangvadi Taila Karnapichu along with Bhairava Rasa. |
Priyangvadi Taila Karnapichu (10-12 drops) once a day for 45 days.
Bhairava Rasa 125 – 250 mg twice a day with honey for 45 days. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having specific symptoms of Karnasrava. |
|
| ExclusionCriteria |
| Details |
a)Pregnant women.
b)Patients with debilitating systemic diseases like Diabetes, Tuberculosis, Hypertension etc.
c)Patients having other aural pathologies like Otomycosis, Otitis externa, Furunculosis.
d)Patient having ear discharge complicated with haemorrhage, Cholesteotoma etc.
e)Patients suffering from any chronic debilitating disease, with other ear pathology and cases which required surgical intervention will be excluded from study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the investigator assessment score for
decrease in the quantity and consistency of ear discharge |
2 months 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Any adverse event reported voluntarily,observed
or enquired |
2 months 15 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
Modification(s)
|
21/01/2021 |
| 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="0"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In modern science management of chronic suppurative otitis media (CSOM) includes
antibiotics, steroids and anti inflammatory drugs having adverse effects on prolonged usage and greater recurrence rate even after surgery. Thus there
is a need to search an effective, inexpensive and safe treatment in CSOM which
is applicable to all patients. Therefore Bhairav Rasa is selected which is
helpful in pratishyaya which is the the root cause of Karnasrava along with the local therapies in the form of karna
pichu and karna avachoornan to stop the
discharge and promote healing of the TM. Thus in this context the hypothesis is proposed that whether Priyangvadi Taila Karnapichu, Lakshadi Avachurnan and oral
administration of Bhairava Rasa are effective in the management of Karnasrava (CSOM) |