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CTRI Number  CTRI/2023/01/048856 [Registered on: 10/01/2023] Trial Registered Prospectively
Last Modified On: 03/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized Factorial Trial 
Public Title of Study   To Find how daily routine affect or help to spread fungal infection  
Scientific Title of Study   An observational study to assess Raktavaha strotodushti Hetu in patients of Dadru  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shital Prakash Borkar 
Designation  PG Scholar 
Affiliation  PDEAs College of Ayurved and Research Centre, Sector no.25 Nigdi Pradhikaran,Pune 
Address  PDEAs College of Ayurved and Research Centre,Rognidan department Sector no.25 Nigdi Pradhikaran,Pune
gajanan nagar,electornic zone ,hingna road
Nagpur
MAHARASHTRA
411044
India 
Phone  9764582078  
Fax    
Email  dr.spborkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrRajesh Mhaske 
Designation  professor 
Affiliation  PDEAs College of Ayurved and Research Centre, Sector no.25 Nigdi Pradhikaran,Pune 
Address  PDEAs College of Ayurved and Research Centre,Rognidan department Sector no.25 Nigdi Pradhikaran,Pune
PDEAs College of Ayurved and Research Centre,Rognidan department Sector no.25 Nigdi Pradhikaran,Pune
Pune
MAHARASHTRA
411044
India 
Phone  9130805556  
Fax    
Email  dr.rajeshmhaske@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shital Prakash Borkar 
Designation  PG Scholar 
Affiliation  PDEAs College of Ayurved and Research Centre, Sector no.25 Nigdi Pradhikaran,Pune 
Address  PDEAs College of Ayurved and Research Centre,Rognidan department Sector no.25 Nigdi Pradhikaran,Pune
gajanan nagar,electonic zone,higna road
Nagpur
MAHARASHTRA
411044
India 
Phone  9764582078  
Fax    
Email  dr.spborkar@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College Of Ayurved and Research Centre, sec no 25 Pradhikaran Nigadi Pune 411044  
 
Primary Sponsor  
Name  PDEAs College Of Ayurved and Research Centre 
Address  PDEAs College Of Ayurved and Research Centre, sec no 25 Pradhikaran Nigadi Pune 411044 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shital Prakash Borkar  Ayurved Rugnalaya and Sterling Multispeciality Hospita Nigadi Pradhikaran Pune 411044  Vitthal Rukmini Road,sector no 27,Rognidan and Dermatology OPD no 118 Nigadi Pradhikaran Pune 411044 Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9764582078

dr.spborkar@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 
Healthy Human Volunteers  Male and Female having history off dadru infection 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Above 18 year to 60 year age group both male and female.
2) History of eating lots of oily,junk food and excessive exposure to sunlight.
 
 
ExclusionCriteria 
Details  1. K/c/o other skin diseases like psoriasis, SLE, Allergic rashes, etc. or
any other major illness related to skin will be excluded.
2. k/c/o any major systemic diseases, pregnancy will be excluded.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observational study to assess Raktavaha strotodushti Hetu in patients of Dadru  one time 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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   N/A 
Date of First Enrollment (India)   15/01/2023 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 05-12-2022 and end date provided 20-02-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information -  NIL
Brief Summary   Ayurveda means the science or knowledge of life. It is complete system of understanding the human being and relationship with the world1,2 . हिताहितंसुखंदुःुखमायुस्तस्यहिताहितम।् मानंचतच्चयत्रोक्तमायुर्वेदुःस: उच्यते॥च.सू१/४१ The science is designed as Ayurveda is advantageous and disadvantageous as well as happy and unhappy state of life along with what is good and bad for life, it is measurement and Life described it self. Ayurveda is the science which provide preventive measures in healthy person and provides wholesome management of disease states which include diet, habit and medicine for total reversal of disease skin is the largest part of the body which is protective covering as well as reflection of the internal system. In Ayurveda dermatological disease with its etiopathogenesis, classification and management and also described the wide range of etiological factor for skin disease including dietary habits and physiological factor. Tvak is the place of vitiation and hence the examining the quality of skin has importance in quality of Raktdhatu. Hence, assessment of Raktdhatu dushtihetu in twak roga like Dadru is important. Tinea corporis (Dadru) is a superficial fungal infection of the body cause by dermatophyte and lesion may involve the trunk, neck and legs. tinea corporis is a superficial infection dermatophyte infection characterized by either inflammatory or non-inflammatory lesion on the glabrous skin. Dadru (Tinea corporis) infection are seen thought the world in warmer and more humid condition it is estimated that 10 to 20% of the world’s population is affected. In India the cause of Dadru is low social economic condition and poor hygiene. So, it is important to study the history of Raktavaha strotodushti hetu sevan in patient of Dadru. The history of hetu sevan is important for the prevention and nidanaparivarjan of the disease. Hence the topic is selected.  
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