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CTRI Number  CTRI/2024/03/064763 [Registered on: 26/03/2024] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of Dadru with Kusthadi Lepa and Khadirasthaka Ghanavati.  
Scientific Title of Study   Efficacy of Kusthadi Lepa and Khadirasthaka Ghanavati in the management of Dadru w.s.r. to Dermatophytosis in children -An open labelled single arm clinical trial 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashok kumar 
Designation  M.D. Scholar 
Affiliation  institute of teaching and research in ayurveda, itra jamnagar 
Address  5th floor academic building institute of teaching and research in ayurveda itra jamnagar gujrat

Jamnagar
GUJARAT
361008
India 
Phone  7891213971  
Fax    
Email  ashokverma675@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Apexa G Vyas 
Designation  Reader 
Affiliation  Institute of teaching and research in ayurveda, itra jamnagar 
Address  5th floor, Academic building Institute of teaching and research in ayurveda, ITRA Jamnagar Gujarat

Jamnagar
GUJARAT
361008
India 
Phone  8767313802  
Fax    
Email  dr_apexa_r@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Ashok kumar 
Designation  M.D. Scholar 
Affiliation  institute of teaching and research in ayurveda, itra jamnagar 
Address  5th floor academic building institute of teaching and research in ayurveda itra jamnagar gujrat

Jamnagar
GUJARAT
361008
India 
Phone  7891213971  
Fax    
Email  ashokverma675@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda 
Address  Institute of Teaching and Research in Ayurveda, Opp City B division Police station, Gurudwara road, Jamnagar, 361008, Gujarat, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nill  nill 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashok Kumar  Institute of Teaching and Research in Ayurveda Hospital  OPD No: 15, OPD of Kaumarbhritya, OPD Block, Institute of Teaching and Research in Ayurveda, Jamnagar 361008 Jamnagar GUJARAT
Jamnagar
GUJARAT 
7891213971

ashokverma675@gmail.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 ArmDrugClassical(1) Medicine Name: Kusthadi Lepa, Reference: charaka chikitsa chapter 7/93, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Khadirasthaka Ghanavati, Reference: Yoga Ratnakar Chikitsa Kustha 63, Route: Topical, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Patients having all signs and symptoms of Dadru which are Kandu, Raga, Mandala.
Patients are in age group of 02-16 years of either sex. 
 
ExclusionCriteria 
Details  Dadru associated with other systemic disorders like Tuberculosis, Juvenile Diabetes that interfere with the course of treatment.
Chronicity more than 2 year. Dadru lesion with secondary infection or any other complicated skin condition.
more than 20cm / very large sized lessions of Dadru.
Patient is on steroid treatment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of intervention on signs & symptoms of Dadru.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Phathophysiology of Dermatophytosis in Children  60 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 
Date of First Enrollment (India)   01/04/2024 
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="0" 
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  
Introduction: Dermatophytosis, also known as ringworm, is a fungal infection of the skin. Typically, it results in a red, itchy, scaly and circular rash. Hair loss may occur in the area affected. Symptoms begin four to fourteen days after exposure. Multiple areas can be affected at a given time. About 40 types of fungus can cause ringworm. They are typically of the Trichophyton, Microsporum or Epidermophyton type. Risk factors include using public showers, contact sports such as wrestling, excessive sweating, contact with animals, obesity and poor immune function. Globally, up to 20% of the population may be infected by ringworm at any given time. Infections of the groin are more common in males, while infections of the scalp and body occur equally in both sexes. Infections of the scalp are most common in children while infections of the groin are most common in the elderly. As Kusthadi Lepa and Khadirasthaka Ghanavati is mentioned in ayurvedic classics for the management of Dadru but still no research work or documentation is available on the use and efficacy of this drug in the management of the Dadru in children.
Information on the Trial procedure and Drug: In this present research work, patient registered at OPD of department of Kaumarbhritya, fulfilling the inclusion criteria will be single group randomly. The duration of the treatment is 4 weeks along with 2 weeks follow up. We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A.
Follow-up: After completion of the treatment, the patient will be followed up for 2 weeks at the interval of 7 days.
Side Effects: We will follow closely and keep track of any unwanted side effects. We may use any other medicine or stop the usage of drug to decrease the symptoms of the side effects.
Results: Data generated during the above study will be presented in a systemic manner and shall be analized statistically.
Benefits: Project will help us to resolve the research question. There may not be any benefit for the society at this stage of the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Dadru. Collected information from this research project will be kept confidential, all outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect.
 
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