| CTRI Number |
CTRI/2021/09/036238 [Registered on: 03/09/2021] Trial Registered Prospectively |
| Last Modified On: |
20/08/2021 |
| 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
|
IT IS CINICAL STUDY TO ACESS THE EFFECT OF NIRGUNDI OIL AND DURVADYA
OIL IN THE MANAGEMENT OF PAMA KUSHTA(SCABIES) IN CHILDREN. |
|
Scientific Title of Study
|
TO EVALUATE THE EFFICACY OF NIRGUNDI TAILA AND DURVADYA
TAILA IN THE MANAGEMENT OF PAMA KUSHTA IN CHILDREN - A
COMPARITIVE CINICAL STUDY. |
| Trial Acronym |
INTERVENTIONAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Adarsha C Patil |
| Designation |
P G SCHOLAR MD KAUMARABHRITYA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PG STUDIES IN KAUMARABHRITYA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MOODBIDIRI DAKSHINA KANNADA DISTRICT KARNATAKA
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9066822656 |
| Fax |
|
| Email |
adarshcpatel8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NARAYAN PAI B |
| Designation |
GUIDE AND ASSOCIATE PROFESSOR DEPARTMENT OF PG STUDIES IN KAUMARABHRITYA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PG STUDIES IN KAUMARABHRITYA ALVAS AYURVEDA MEDICAL COLLEGE MOODBIDIRI DAKSHINA KANNADA DISTRICT KARNATAKA
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adarsha C Patil |
| Designation |
PG SCHOLAR MD KAUMARABHRITYA |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PG STUDIES IN KAUMARABHRITYA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MOODBIDIRI DAKSHINA KANNADA DISTRICT KARNATAKA
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9066822656 |
| Fax |
|
| Email |
adarshcpatel8@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYAGIRI MOODBIDIRI DAKSHINA KANNADA DISTRICT KARNATAKA 574227 |
|
|
Primary Sponsor
|
| Name |
SUMATHI N |
| Address |
SUMATHI N TALUK OFFICE CHIKKANAYAKANA HALLI TUMKUR DISTRICT KARNATAKA 572214 |
| Type of Sponsor |
Other [MOTHER] |
|
|
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 ADARSHA C PATIL |
ALVAS AYURVEDA MEDICAL COLLEGE MOODBIDIRI |
KAUMARABHRITYA OPD GROUND FLOOR OF ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL DAKSHINA KANNADA KARNATAKA
Dakshina Kannada
KARNATAKA |
9066822656
adarshcpatel8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL CLINICAL ETHICAL COMMITEE ALVAS AYURVEDA MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: PAMAÂ (KACCU), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DURVADYA TAILA |
EXTERNAL APPLICATION OF DURVADYA TAILA TO EACH PATIENT OF PAMA KUSHTA IN QS 2 TIMES PER DAY FOR A PERIOD OF 10DAYS |
| Intervention |
NIRGUNDI TAILA |
EXTERNAL APPLICATION OF NIRGUNDI TAILA TO EACH PATIENTS OF PAMA KUSHTA IN QS 2 TIMES PER DAY FOR PERIOD OF 10DAYS |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Subject who fulfil diagnostic criteria
Irrespective of gender religion and socio economic status
Age between 6 to 16 years |
|
| ExclusionCriteria |
| Details |
Subjects with any other skin manifestations
Subjects with any other systemic disorder |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjects with minimum 2 following Lakshanas
Shyava Aruna Varna pidika (black head papules vesicles)
Kandu paridaha (pruritis)
Srava (secretion) |
4 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)
|
15/09/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a Comparative Clinical study to evaluate the efficacy of Nirgundi taila and Durvadya taila in the management of Pama Kushta in children for 10days in 40 patients will be conducted in Alvas Ayurveda medical college and hospital Moodbidri Dakshina kannada India. primary outcome measure will be relief from Shyava Aruna Varna pidika (black head papules vesicles), Kandu paridaha (pruritis),Srava (secretion) in 15 days. |