| CTRI Number |
CTRI/2024/12/077799 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To observe how KARAVIRADYA TAILA work in PAMA skin disease in children |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF KARAVIRADYA TAILA IN MANAGEMENT OF PAMA KUSHTA IN CHILDREN |
| Trial Acronym |
To check the efficacy of drug so patients are selected randomly |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ASHWITH A |
| Designation |
PG SCHOLAR |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Moodubidre ,Dakshina Kannada |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, VIDYAGIRI MOODUBIDRE, DAKSHINA KANNADA , KARNATAKA -574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8861421208 |
| Fax |
|
| Email |
ashwithgatty02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan Pai B |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital,Vidyagiri, Moodubidre ,Dakshina Kannada |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidre, Dakshina Kannada Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narayan Pai B |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital,Vidyagiri, Moodubidre ,Dakshina Kannada |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidre, Dakshina Kannada Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL,VIDYAGIRI OPD and ipd and other refferal camps
Moodbidre, -574227, Dakshina Kannada, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
DR ASHWITH A |
| Address |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, MOODUBIDRE -574227 |
| 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 |
| DR ASHWITH |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL,MOODUBIDRE ,DAKSHINA KANNADA,KANNADA |
DEPARTMENT OF KAUMARABHRITYA, bala roga OPD, Room no 2, Ist floor
Dakshina Kannada
KARNATAKA |
8861421208
ashwithgatty02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Alvas Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B86||Scabies. Ayurveda Condition: Kusht, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Karaviradya Taila, Reference: Bhaishjya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: Karaviradya Taila external application on pama kushta for children age between 6-16 years for BD morning and evening for 1hour followed by hotwater wash for 10days, follow up on 15th day. |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject to fulfil the diagnostic criteria.
2. irrespective of gender, religion and socioeconomic status. 3. Age between the age group 6-16 years. |
|
| ExclusionCriteria |
| Details |
1. Kustha other than Pama.
2. Subjects with any other systemic disorder. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 40 sample size divided into 2 groups of 20 each group A and group B |
2weeks(15 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to reduce the outcome of
Shyava Aruna Varna pidika( black head papules , vesicles),
Srava ( discharge),
Kandu paridaha (pruritis),
Toda( pain) |
15days |
|
|
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)
|
13/12/2024 |
| 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="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study is randomized, parallel group , activity controlled comparative clinical study with Durvadya Taila as standard drug and Karaviradya Taila as interventional drug with the dosage as quantity sufficient as external application for 10 days morning and evening for an hour followed by hotwater wash. This study will be conducted on subjects belonging to the age group 6-16 years who has given written and verbal consent by parents for undergoing clinical study. The study will be conducted in Alvas Ayurveda Medical College and Hospital, Moodubidire. Interventional period of study is 15 days and assessment will be done before treatment, 5th day, 10th day and follow up on 15th day. |