| CTRI Number |
CTRI/2020/11/029371 [Registered on: 25/11/2020] Trial Registered Prospectively |
| Last Modified On: |
24/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study to evaluate the efficacy of yavakshara application in the management of Tundikeri ( Chronic Tonsillitis ) |
|
Scientific Title of Study
|
clinical study to evaluate the efficacy of yavakshara pratisarana in the management of Tundikeri ( Chronic Tonsillitis ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshata Narayana Moger |
| Designation |
priliminary pg scholar |
| Affiliation |
Sri Dharmastala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
| Address |
Akshata Narayana Moger
Priliminary pg scholar
Department of shalakya tantra
S D M College of Ayurveda And Hospital .
Tanniruhalla
Bengaluru - Mangaluru road
Hassan
573201
Hassan
KARNATAKA
573201
India |
| Phone |
9448763144 |
| Fax |
|
| Email |
mgakku206@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhijith H N |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmastala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
| Address |
Abhijith H N
Associate professor
Department of shalakya tantra
S D M College of Ayurveda And Hospital .
Tanniruhalla
Bengaluru- Mangaluru road
Hassan
573201
Hassan
KARNATAKA
573201
India |
| Phone |
9448763144 |
| Fax |
|
| Email |
abhijithhn7878@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshata Narayana Moger |
| Designation |
priliminary pg scholar |
| Affiliation |
Sri Dharmastala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
| Address |
Akshata Narayana Moger
priliminary pg scholar
department of shalakya tantra
S D M College of Ayurveda And Hospital
Tanniruhalla
Bengaluru -Mangaluru road
573201
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448763144 |
| Fax |
|
| Email |
mgakku206@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
|
|
Primary Sponsor
|
| Name |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
BM ROAD HASSAN
TANNIRUHALLA
573201 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Akshata Narayana Moger |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan |
Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital,
Department of shalakya tantra
Room number -14
Tanniruhalla
Bengaluru -Mangaluru road
Hassan
573201
Hassan
KARNATAKA |
9448763144
mgakku206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri Dharmasthala Manjunatheshwara college of Ayurveda And Hospital Hasan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
yava kshara |
Dose -as required (quantity sufficient)
Route of application -oral Application over tonsillar area
Time of administration -untill jambuphala sadrusha(1 min)
Duration -one day |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1-patients clinically diagnosed with Tundikeri and fit for ksharakarma
2-ready to sign informed cosent form
3-patient not respond to medical management will be included
3-willing to sign the informed assent form (age group between 16-18 years) |
|
| ExclusionCriteria |
| Details |
1- Acute tonsillitis, peritonsillar abscess,Acute otitismedia,Tonsilar cyst
2-uncontrolled Hypertension and Diabetes Mellitus
3-pregnency,lactation,puerperal stage |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from disease |
3 months |
|
|
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)
|
30/11/2020 |
| 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="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Present study will be an open label ,single arm,clinical study in Tundikeri (n=30)selected using convenience /purposive sampling technique with pre and post design conducted in teritary Ayurveda healthcare centre attached to a teaching institute,situated at the district headquatres in south india. A minimum of 30 patients suffering from Tundikeri will be selected with interventin of Yavakshara pratisarana |