CTRI Number |
CTRI/2023/05/053331 [Registered on: 31/05/2023] Trial Registered Prospectively |
Last Modified On: |
25/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Ayurvedic oil in the management of Dadru in children |
Scientific Title of Study
|
A randomized clinical comparative study of Karanjadi oil (a hypothetical compound oil) and Rasanjanadi lepa in the management of Dadru In Children |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
JASVIR SINGH BEHNIWAL |
Designation |
PG SCHOLAR |
Affiliation |
Shri Krishna Govt Ayurvedic College and Hospital,Kurukshetra pin 136118 |
Address |
Room no.- 100, PG Department of Kaumarbhritya Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, umri road, Kurukshetra
Kurukshetra HARYANA 136118 India |
Phone |
7015744098 |
Fax |
|
Email |
jassurockyraj1995@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
JASVIR SINGH BEHNIWAL |
Designation |
PG SCHOLAR |
Affiliation |
Shri Krishna Govt Ayurvedic College and Hospital,Kurukshetra pin 136118 |
Address |
Room no.- 100, PG Department of Kaumarbhritya Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, umri road, Kurukshetra
Kurukshetra HARYANA 136118 India |
Phone |
7015744098 |
Fax |
|
Email |
jassurockyraj1995@gmail.com |
|
Details of Contact Person Public Query
|
Name |
JASVIR SINGH BEHNIWAL |
Designation |
PG SCHOLAR |
Affiliation |
Shri Krishna Govt Ayurvedic College and Hospital,Kurukshetra pin 136118 |
Address |
Room no.- 100, PG Department of Kaumarbhritya Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, umri road, Kurukshetra
Kurukshetra HARYANA 136118 India |
Phone |
7015744098 |
Fax |
|
Email |
jassurockyraj1995@gmail.com |
|
Source of Monetary or Material Support
|
Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra Haryana |
|
Primary Sponsor
|
Name |
Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra Haryana |
Address |
Shri Krishna Government Ayurvedic College and Hospital, sector8, umri road, Kurukshetra |
Type of Sponsor |
Government 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 Shambhu Dayal Sharma |
Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra Haryana 136118 |
Room no.- 100, PG Department of Kaumarbhritya Shri Krishna Govt. Ayurvedic College and Hospital, Sector 8, umri road, Kurukshetra Kurukshetra HARYANA |
9416119252
sharmasddr@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Karanjadi oil ( A hypothetical compound oil), Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasanjandi lepa, Reference: charak sutra 3/13, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 15(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
16.00 Year(s) |
Gender |
Both |
Details |
1.Parents of children willing to participate in the research trial.
2.The patients with lakshans (Sign & Symptoms) of Dadru.
3.Children of either sex aged between 3 years to 1 |
|
ExclusionCriteria |
Details |
1. Children below 3 years and above 16 years of age.
2. Children under long standing medication.
3. Chronicity more than 2 years.
4. Patient suffering with systemic disorders like auto immune disease etc., which interfere with the course of treatment, will be excluded.
5. Dadru associated with other skin disease will be excluded |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Change in subjective and objective criteria Dadru |
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To collect literature of Dadru from different medical texts of Ayurveda and modern.
2.To understand and analyze the disease Dadru in relation with Tinea.
3.To evaluate the effect of Pathya-Apathya counseling in the management of Dadru |
7 weeks |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
30/06/2023 |
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="0" Days="0" |
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
|
Skin ailments are common in children. Children are particularly susceptible to dermatophytic infections because of their poor personal hygiene habits and poor environmental sanitation. Superficial tinea infections are some of the most common dermatological conditions in children. Hence, it gives negative impact on health and well-being of children. The Tinea infections are prevalent globally but they are common in tropics and may reach epidemic proportions in geographical areas with higher humidity, over-population and poor hygienic living conditions. They can spread by direct contact from other people (anthropophilic organisms), animals (zoophilic organisms), and soil (geophilic organisms), as well as indirectly from fomites. According to Acharya Charaka, Nidana sevan leads to prakopa of Tridoshas and thus the vitiated Doshas will get aashrya in Twaka, Rakta, Mamsa and Ambu causing the shaithilyata in these Dhatus leading to the manifestation of Kustha roga. So, the study has been undertaken to understand each and every aspect related to Dadru Kustha and proper management protocol. Ayurvedic management is very helpful to improve the life of children suffering from Dadru Kustha. |