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CTRI Number  CTRI/2022/01/039115 [Registered on: 04/01/2022] Trial Registered Prospectively
Last Modified On: 03/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Study on ayurveda drugs Shashanklekhadi Churna and Edgajadi Lepa in the treatment of Skin disease 
Scientific Title of Study   A clinical study to evaluate the efficacy of Shashanklekhadi Churna and Edgajadi Lepa in the management of Mandal Kushtha w.s.r. to Psoariasis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayushi Bhaskar 
Designation  P.G. Scholar 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  PG Department of kaya chikitsa Madan Mohan Malviya Govt. Ayurved College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  8619697146  
Fax    
Email  ayushibhaskar18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indumati Sharma 
Designation  Associate Professor & Guide 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  PG Department of kaya chikitsa Madan Mohan Malviya Govt. Ayurved College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7976972310  
Fax    
Email  drindusharma4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Indumati Sharma 
Designation  Associate Professor & Guide 
Affiliation  Madan Mohan Malviya Govt. Ayurved College Udaipur 
Address  PG Department of kaya chikitsa Madan Mohan Malviya Govt. Ayurved College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7976972310  
Fax    
Email  drindusharma4@gmail.com  
 
Source of Monetary or Material Support  
MADAN MOHAN MALVIYA GOVT. AYURVED COLLEGE UDAIPUR 
 
Primary Sponsor  
Name  Madan Mohan Malviya Govt Ayurved College Udaipur 
Address  Madan Mohan Malviya Govt. Ayurved College Radaji Circle Ambamata Udaipur 313001 
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 INDUMATI SHARMA  Rajvaidya Premshankar Sharma Ayurved Chikitsalaya Ambamata Udaipur  OPD ROOM NO. 3, PG DEPARTMENT OF KAYA CHIKITSA,Rajvaidya Premshankar Sharma Ayurved Chikitsalaya Ambamata Udaipur
Udaipur
RAJASTHAN 		 7976972310

drindusharma4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee Madan Mohan Malviya Govt. Ayurved College Udaipur  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: Mandal Kushtha ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shashanklekhadi Churna, Reference: Chakradutta 50/53, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Til Tail), Additional Information:
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: Chakradutta 50/35, Procedure details: Edgajadi Lepa10gm will be apply topically with Cow urine for 60 days.)
3Comparator ArmProcedure-lepa, लेप (Procedure Reference: Chakradutta 50/35, Procedure details: Edgajadi Lepa 10gm will be apply topically with Cow urine for 60 days.)
(1) Medicine Name: Shashankhlekhadi Churna, Reference: Chakradutta 50/53, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 60 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients willing for trial.
2. The patients who ages in between 20 - 70 years were selected.
3. The patients having clinical signs and symptoms of Mandal Kushtha (Psoriasis).
4. The patients having complaints less than 3 years duration 
 
ExclusionCriteria 
Details  1. Patients below the age of 20 years and above 70 years.
2. Patients with illness >3 years.
3. Patients with long term Steroid and cytotoxic treatment taking more than 3 years.
4. Patients having concomitant illness like DM, AIDS and other Auto immune disorders.
5. Patients with evidence of any malignancy.
6. Any drug addiction.
7. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in sign & symptoms  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy of treatment   2 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   04/01/2022 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   This study is about evaluating the efficacy of Shashankhlekhadi Churna & Edgajadi Lepa in the management of Mandal kushtha w.s.r. to Psoriasis. there will be 3 groups in group A : 10 patients will be treated for Shashankhlekhadi Churna orally 3gm with til tail. In Group B : 10 patients will be treated with Edgajadi Lepa 10gm topically with Cow urine. In group C : 10 Patients will be  treated with both Shashankhlekhadi Churna 3 gm orally & Edgajadi Lepa 10gm topically . 
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