| CTRI Number |
CTRI/2021/07/034738 [Registered on: 09/07/2021] Trial Registered Prospectively |
| Last Modified On: |
06/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Application of Gunja oil in Dandruff disease in children |
|
Scientific Title of Study
|
A CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF APPLICATION OF GUNJATAILA IN DARUNAKA IN CHILDREN |
| Trial Acronym |
GTID |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRIYANKA H S |
| Designation |
MD KAUMARABHRITYA ALVAS AYURVEDA MEDICAL COLLEGE MOODBIDRI DAKSHIN KANNADA 574 |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE MOODBIDRI DAKSHIN KANNADA KARNATAKA 574227 |
| Address |
DR PRIYANKA H S PG SCHOLAR MD KAUMARABHRITYA GROUND FLOOR ALVAS AYURVEDA MEDICAL COLLEGE MOODBIDRI
DR PRIYANKA H S PG SCHOLAR MD KAUMARABHRITYA GROUND FLOOR ALVAS AYURVEDA MEDICAL COLLEGE MOODBIDRI
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9169092019 |
| Fax |
|
| Email |
priyasanjeevini5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHARADA M K |
| Designation |
GUIDE AND HOD DEPARTMENT OF PG STUDIES IN KAUMARABHRITYA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MOODBIDRI DAKSHIN KANNADA KARNATAKA 574227 |
| Address |
DEPARTMENT OF PG STUDIES IN KAUMARABHRITYA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MOODBIDRI DAKSHIN KANNADA KARNATAKA 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9448005577 |
| Fax |
|
| Email |
sharadacrown2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRIYANKA H S |
| Designation |
PG SCHOLAR MD KAUMARABHRITYA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE MOODBIDRI DAKSHIN KANNADA KARNATAKA 574227 |
| Address |
DR PRIYANKA H S PG SCHOLAR MD KAUMARABHRITYA ALVAS AYURVEDA MEDICAL COLLEGE GROUND FLOOR MOODBIDRI DAKSHIN KANNADA KARNATAKA 574227
DR PRIYANKA H S PG SCHOLAR MD KAUMARABHRITYA ALVAS AYURVEDA MEDICAL COLLEGE GROUND FLOOR MOODBIDRI 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9169092019 |
| Fax |
|
| Email |
priyasanjeevini5@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYAGIRI MOODBIDRI DAKSHIN KANNADA DISTRICT KARNATAKA 574227 |
|
|
Primary Sponsor
|
| Name |
DR PRIYANKA H S |
| Address |
DR PRIYANKA H S PG SCHOLAR MD KAUMARABHRITYA ALVAS AYURVEDA MEDICAL COLLEGE MOODBIDRI 574227 |
| Type of Sponsor |
Other [] |
|
|
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 PRIYANKA H S |
ALVAS AYURVEDA MEDICAL COLLEGE MOODBIDRI |
Kaumarabhritya OPD ground floor Alvas Ayurveda Medical college and hospital dakshina kannada Karnataka
Dakshina Kannada
KARNATAKA |
9169092019
priyasanjeevini5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitional clinical ethical comitee alvas ayurveda medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DARUNAKAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GUNJA TAILA |
EXTERNAL APPLICATION OF GUNJA TAILA ON SCALP TO EACH PATIENT OF DARUNAKA REQUIRED QUANTITY ONCE IN A WEEK FOR 28 DAYS |
| Comparator Agent |
KETOKONOZOLE LOTION |
APPLICATION OF KETOKONOZOLE LOTION ON SCALP TO EACH PATIENT OF DARUNAKA ONCE IN A WEEK FOR 28 DAYS |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Subjective full-filling diagnostic criteria
Age group 8-16 years irrespective of gender religion & socio economic status
|
|
| ExclusionCriteria |
| Details |
Patient with other scalp diseases
Dandruff associated with systemic involvement
Allergic manifestation
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
ShiroKandu
Kesachyuthi
Shirorukshana
Twaksphutana
|
7 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2021 |
| 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="1"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IT IS A
CONTROLLED CLINICAL STUDY
TO EVALUATE THE EFFICACY OF APPLICATION OF GUNJATAILA IN DARUNAKA IN
CHILDREN FOR 29 DAYS IN 40 PATIENT WILL BE CONDUCTED IN ALVAS AYURVEDIC MEDICAL COLLEGE AND HOSPITAL MOODBIDRI,VIDHYAGIRI,DAKSHIN KANNADA,INDIA.PRIMARY OUTCOME MEASURE WILL BE RELIEF FROM KANDU,KESHACHYUTHI,RUKSHATA AND TWAKSPHUTANA IN 49 DAYS .
|