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CTRI Number  CTRI/2021/05/033562 [Registered on: 12/05/2021] Trial Registered Prospectively
Last Modified On: 11/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Fungal infection 
Scientific Title of Study   Evaluation of the combined effect of Laghu Manjisthadi kwath and Adagazadi lepa in 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 DK Goyal 
Designation  Professor 
Affiliation  Gurukul campus UAU Haridwar 
Address  OPD NO. 5 PG Department of Kaya Chikitsa Department Gurukul campus UAU Haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  9411731180  
Fax    
Email  dineshdr157@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr DK Goyal 
Designation  Professor 
Affiliation  Gurukul campus UAU Haridwar 
Address  OPD NO. 5 PG Department of Kaya Chikitsa Department Gurukul campus UAU Haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  9411731180  
Fax    
Email  dineshdr157@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr DK Goyal 
Designation  Professor 
Affiliation  Gurukul campus UAU Haridwar 
Address  OPD NO. 5 PG Department of Kaya Chikitsa Department Gurukul campus UAU Haridwar

Hardwar
UTTARANCHAL
249401
India 
Phone  9411731180  
Fax    
Email  dineshdr157@gmail.com  
 
Source of Monetary or Material Support  
Gurukul campus UAU Haridwar 
 
Primary Sponsor  
Name  Gurukul Campus UAU Haridwar 
Address  Gurukul Campus UAU Haridwar 
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 
Amandeep Kaur  Gurukul Campus UAU Haridwar  OPD No.5 PG Department of Kaya Chikitsa Gurukul Campus UAU Haridwar
Hardwar
UTTARANCHAL 		 7017991277

kauramandeep0392@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
UAU,Gurukul campus, Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laghu Manjishtadi Kwath and Adagazadi Lepa  40ml BD before meal will be given orally for 30 days and Lepa will be applied externally on affected area twice a day for 30 days. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having classical features of dadru.
Both previously treated and fresh cases will be taken.
Chronicity upto 5 years.
Patients of either sex.
Patients from age group 18-60 years. 
 
ExclusionCriteria 
Details  Patient suffering from Dibetes Mellitus.
Pregnant and lactating women.
Chronicity more than 5 years.
Patients of age below 18 and more than 60 years.
Patients of Dadru with any chronic systemic disorder which interferes with the present study.
Patients with serious medical illness and psychiatric disorder will be excluded.
Drug induced reaction.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in subjectve parameters like
1)Kandu(itching)
2)Raga(erythema)
3)Size of utsanna mandal(elevated circular skin lesion)
4)No.of utsanna zero mandal(elevated circular skin lesion)
5)Pidika(eruption) 		 At 1st,10th,20th,30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in objectve parameters-1)TLC
2)DLC
3)ESR
4)RBS 		 At 1st and 30th day 
 
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   N/A 
Date of First Enrollment (India)   18/05/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kauramandeep0392@gmail.com].

  6. For how long will this data be available start date provided 18-05-2021 and end date provided 18-05-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a open label, single arm clinical trial to determine the Efficacy of Laghu Manjishtadi Kwath and Adagazadi lepa in Dadru for age group between 18-60 years daily for 30 days . The study will be conducted at UAU, Gurukul Campus, Haridwar in 40 patients. The assessment will be done on the basis of Subjective and Objective parameters. The study will be conducted at OPD/IPD level of P.G. Department of Kaya Chikitsa. The assessment will be done at 1st,10th day, 20th day, 30th day of the clinical trial and the results obtained will be tabulated and statistically analyzed using appropriate tests. 
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