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CTRI Number  CTRI/2023/06/054474 [Registered on: 27/06/2023] Trial Registered Prospectively
Last Modified On: 24/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Kushthaghna Mahakashaya and Tutthadi Lepa in Psoriasis  
Scientific Title of Study   A Clinical Study to evaluate the efficacy of Kushthaghna Mahakashaya and Tutthadi Lepa in the management of Mandal Kushtha W.S.R Psoriasis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheetal Katariya 
Designation  PG Scholar 
Affiliation  Madan Mohan Malviya Government Ayurved College  
Address  PG Scholar Kayachikitsa Department Madan Mohan Malviya Government Ayurved College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9799319457  
Fax    
Email  sheetalkataria1894@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sheetal Katariya 
Designation  PG Scholar 
Affiliation  Madan Mohan Malviya Government Ayurved College  
Address  PG Scholar Kayachikitsa Department Madan Mohan Malviya Government Ayurved College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9799319457  
Fax    
Email  sheetalkataria1894@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ravi Sharma 
Designation  Proffesor and Head of Deaprtment of Kayachikitsa 
Affiliation  Madan Mohan Malviya Government Ayurved College  
Address  Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9414419259  
Fax    
Email  rspgkcj2015@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Government Ayurved College, Udaipur, Rajasthan 
 
Primary Sponsor  
Name  Madan Mohan Malviya Government Ayurved College, Udaipur, Rajasthan 
Address  Madan Mohan Malaviya Government Ayurved College PG Department of kayachikitsa 
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 Sheetal katariya  Madan Mohan Malviya Government Ayurved College   Department of Kayachikitsa OPD no 1 Government Ayurved Hopsital Motichohtta 303001
Udaipur
RAJASTHAN 
9799319457

sheetalkataria1894@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Madan Mohan Malaviya Government Ayurved College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KUSHTHAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kushthaghna Mahakashaya, Reference: Charak samhitha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Tutthadi lepa, Reference: Charak samhitha, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Kushthaghna Mahakashaya, Reference: Charak samhitha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Ptients willing for trial
The patient who age in between 20 year to 60 year
The patient having clinical sign and symptom of Madal Kushtha (Psoriasis)
the patient having complaints less than 5 year duration 
 
ExclusionCriteria 
Details  Patients below the age of 20 year and above 60 year
Patients with illness more than 5 year
Patient with long term steroid and cytotoxic treatment taking more than 5 year
Patient having concomitant iliiness like Diabeted Mallitus AIDS and other auto immune disorder
patient with evidence of any malignancy are exluded
Any drud addiction if present are excluded
Pregnant and lactatic women are excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Improvement in the signs and symptoms of Mandal kushtha
2)Reduction in the PASI score 
3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)Improvement in signs & symptoms of Mandal kushtha
2)Reduction in the PASI score 
2 weeks,4 weeks,6 weeks,8 weeks & 10 weeks 
 
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)   15/07/2023 
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="0"
Months="3"
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   This study is about evaluate the efficacy of Kushthaghna Mahakashaya and Tutthadi Lepa in the management of Mandal kushtha with special reference to Psoriasis.
This is a Double- arm study
20 patients will be given Kushthaghna Mahakashaya in the form of Kashaya/Kwatha  in the quantity of 10 gm twice a day before meal for 90 days
20 patients will be given Kushthaghna Mahakashaya in the form of Kashaya/Kwatha  in the quantity of 10 gm twice a day before meal along with Tutthadi Lepain the quantity of 10 gm twice a day after meal for 90 days 
follow up - 15 days gap during trail period
 
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