| CTRI Number |
CTRI/2025/04/084052 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| 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 Ayurvedic Medicated oil in Scabies in Children |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Trina Taila In Management Of Pama Kushta In Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Megha A Sirigere |
| Designation |
PG scholar |
| Affiliation |
Alvas ayurveda Medical Collage and Hospital, Moodubidri |
| Address |
Alvas Ayurveda Medical College and Hospital,
Vidyagiri
Moodubidri
Dakshinakannada
574227
Alvas Ayurveda Medical College and Hospital,
Vidyagiri
Moodubidri
Dakshinakannada
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7019027684 |
| Fax |
|
| Email |
megha.a.sirigere@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan pai |
| Designation |
HOD and Professor |
| Affiliation |
Alvas ayurveda Medical Collage and Hospital, Moodubidri |
| Address |
Alvas Ayurveda Medical College and Hospital,Department Of Kaumarabritya
Vidyagiri
Moodubidri
Dakshinakannada
574227
Alvas Ayurveda Medical College and Hospital,Department Of Kaumarabritya
Vidyagiri
Moodubidri
Dakshinakannada
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha A Sirigere |
| Designation |
PG scholar |
| Affiliation |
Alvas ayurveda Medical Collage and Hospital, Moodubidri |
| Address |
Alvas Ayurveda Medical College and Hospital,
Vidyagiri
Moodubidri
Dakshinakannada
574227
Alvas Ayurveda Medical College and Hospital,
Vidyagiri
Moodubidri
Dakshinakannada
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7019027684 |
| Fax |
|
| Email |
megha.a.sirigere@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital,
Vidyagiri
Moodubidri
Dakshinakannada |
|
|
Primary Sponsor
|
| Name |
other |
| Address |
Alvas Ayurveda Medical College and Hospital
Deptartment of kaumarabritya
Vidyagiri
Moodubidri
Dakshinakannada
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 Megha A Sirigere |
Alvas ayurveda medical college and hospital moodubidri |
Department of Kaumarabritya
room no- 2
First floor
Vidyagiri
Moodubidri
Dakshina kannada-574227
Dakshina Kannada
KARNATAKA |
7019027684
megha.a.sirigere@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee alvas ayurveda medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: PAMA (KACCU), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trina taila, Reference: Vangasena samhita , Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Durvadya taila , Reference: Bhaishjya ratanavali, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling the diagnostic criteria
Irrespective of gender, religion, socio economic status
age group of 3 to 15 years
|
|
| ExclusionCriteria |
| Details |
Subjects suffering from chronic skin disorder, immunosuppressed,systemic disorder.
Norwegian scabies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recruitment of patients sufferings from scabies .
management of scabies in children
|
Recruitment of patients sufferings from scabies .
management of scabies in
children
Total time period of medication is 7 days
Total time period including followup is 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recruitment of patients sufferings from scabies .
management of scabies in children
comparing the outcome of trial drug with the standard drug |
Total time period of medication is 7 days
Total time period including followup is 15 days |
|
|
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)
|
15/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="5" |
|
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
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF TRINA TAILA IN MANAGEMENT OF PAMA KUSHTA IN CHILDREN. Pama kushta one among the kshudra kushta , which exhibit specific lakshana like shweta ,shyava ,aruna pidakas, kandu, srava, paridaha adhika ruja, sukshma , bahu pidaka’s on sphik, pani ,pada , other parts of the body. It is co-related with scabies in dermatology HYPOTHESIS: • H0-There is neither statistically significant difference between the effect of Trina taila and Durvadya taila nor Trina taila is better than Durvadya taila in the management of Pama kushta in children. • H1- There is statistically significant difference between the effect of Trina taila and Durvadya taila , with Trina taila better than Durvadya taila in management of Pama kushta in children. METHOD OF COLLECTION OF DATA SAMPLE SIZE: 40 subjects fulfilling the Diagnostic and Inclusion criteria will be selected allotted in to groups A and B with 20 subjects each. • Group(A) Trina Taila Group: The subjects of this group will be treated with Trina taila application over the lesions with quantity sufficient dose at morning and evening time followed by warm water wash for 7 days. • Group (B) Durvadya taila group: The subjects of this group will be treated with Durvadya taila application over the lesions with quantity sufficient dose at morning and evening time followed by warm water wash for 7 days. |