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CTRI Number  CTRI/2022/07/043946 [Registered on: 12/07/2022] Trial Registered Prospectively
Last Modified On: 22/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluate the effect of modified kushthaghna kwath and tutthadi lepa in skin disorder(dadru kushtha) 
Scientific Title of Study   A Randomized Controlled Clinical Study to Evaluate the Efficacy of "Modified Kushthaghna Mahakashaya Kwatha and Tutthadi Lepa"in the Management of Dadru Kushtha with special reference to Tinea corporis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VIJAY KUMARI SHARMA 
Designation  P.G. Scholar 
Affiliation  National Institute of Ayurveda,Jaipur 
Address  Department of Kayachikitsa National Institute of Ayurveda,Jaipur Jorawar singh gate,near Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  9587559406  
Fax    
Email  vijaysharmavjvj@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr HML MEENA 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda,Jaipur 
Address  Department of Kayachikitsa National Institute of Ayurveda,Jaipur Jorawar singh gate,near Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  9461297017  
Fax    
Email  hari_mohan68@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  VIJAY KUMARI SHARMA 
Designation  P.G. Scholar 
Affiliation  National Institute of Ayurveda,Jaipur 
Address  Department of Kayachikitsa National Institute of Ayurveda,Jaipur Jorawar singh gate,near Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  9587559406  
Fax    
Email  vijaysharmavjvj@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda,Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  Department of kayachikitsa National Institute of Ayurveda,Jaipur Jorawar singh gate,near Amer Road,jaipur(Rajasthan) 
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 
VIJAY KUMARI SHARMA  National Institute of Ayurveda,Jaipur and associated hospitals  Department of Kayachikitsa National Institute of Ayurveda,Jaipur Jorawar Singh Gate,Amer Road PIN Code 302002
Jaipur
RAJASTHAN 		 9587559406

vijaysharmavjvj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Modified Kushthaghna Mahakashaya Kwatha, Reference: Charak samhita sutrasthan 4/13, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Tutthadi Lepa, Reference: Charak samhita sutrasthan 3/12, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-tab fluconazole and clotrimazole ointmentTAB FLUCONAZOLE 150 MG ONCE WEEKLY AND CLOTRIMAZOLE 1% OINTMENT FOR LOCAL APPLYCATION EVERY NIGHT FOR 30 DAYS
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient willing to participate in clinical trial.

2. The patients of either sex having age between 18 -60 years.

3. The patients having clinical signs and symptoms of Dadru Kushtha with special reference to Tinea Corporis
4. Patients with chronicity of illness < 5years
 
 
ExclusionCriteria 
Details  1. Patients with long-term history of steroid and cytotoxic treatment.

2. Patients having concomitant illness like uncontrolled Hypertension, Diabetes Mellitus and known case of HIV, Malignancy.
3. Patients having other associated skin disease like eczema, secondary bacterial infection, etc.
4. Patient participated in any clinical trial with in last six months.

5. Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Kandu (Itching)

2. Raga (Color)

3. Mandala (Elevated Margin)
 
30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Mandala (No of Lesions)

2. Mandal (Size of Lesion)

3. Pidika (Eruption)
 		 30 Days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/08/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Recurrence is common with major side effects for overcoming adverse consequences need arises to go to natural herbal remedies. Hence, it is necessary to study and reinterpret the effect of drugs mentioned in Ayurveda classics and asses its efficacy particularly in this condition. After reviewing the literature keeping in mind the limitations of current standard treatment, two drugs has been selected which are supposed to be effective in conditions similar to Dadru Kushta with special reference to Tinea corporis. In the present clinical trial efficacy of Modified Kushthaghna Mahakashaya kwath and tutthadi lepa will be evaluated in the management of Dadru Kushtha with special reference to  Tinea Corporis.  
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