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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B359||Dermatophytosis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther 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: -
2Comparator ArmDrugClassical(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.

 
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