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CTRI Number  CTRI/2023/05/052168 [Registered on: 01/05/2023] Trial Registered Prospectively
Last Modified On: 17/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of kosthashuddhi( Evacuation of bowel) in skin disease by using herbal formulations. 
Scientific Title of Study   A Randomised comparative trial to evaluate the effect of Lelitak Prayog in Mandala Kushtha with and without Kosthashuddhi w.s.r.toTwak Sharir. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepshikha 
Designation  P G Scholar  
Affiliation  National institute of Ayurveda Jaipur  
Address  Dept of Kriya Sharir National institute of Ayurveda Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  09050652465  
Fax    
Email  pshikha2768@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Chhaju Ram Yadav  
Designation  Professor  
Affiliation  National institute of Ayurveda Jaipur  
Address  Dept of Kriya Sharir National institute of Ayurveda Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9460866101  
Fax    
Email  dr.yadavcr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Chhaju Ram Yadav  
Designation  Professor  
Affiliation  National institute of Ayurveda Jaipur  
Address  Dept of Kriya Sharir National institute of Ayurveda Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9460866101  
Fax    
Email  dr.yadavcr@gmail.com  
 
Source of Monetary or Material Support  
National institute of Ayurveda Jaipur Rajasthan  
 
Primary Sponsor  
Name  National institute of Ayurveda  
Address  Near Jorawar Singh gate Amer Road jaipur rajasthan  
Type of Sponsor  Research institution and hospital 
 
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 
Deepshikha   National institute of Ayurveda Jaipur   OPD 3 Dept of Kriya Sharir near Jorawar Singh gate Amer Road jaipur rajasthan
Jaipur
RAJASTHAN 		 09050652465

pshikha2768@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 
Patients  (1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: MANDALAKUSHTHAH/KAPAJAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Trivrut ghanavati, Reference: Charak Chikitsa chikitsa 7, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: hs, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water ), Additional Information: -along with Lelitak prayog 250 mg BD with Amla swarasa and honey for 1 month
2Comparator ArmDrugClassical(1) Medicine Name: Lelitak prayog , Reference: Charak Chikitsa 7, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -amla swaras and honey ), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects with classical sign and symptoms of mandala kushtha
Subjects who are willing to participate and sign the informed consent form. 
 
ExclusionCriteria 
Details  Pregnant women and lactating mothers
Subjects suffered from other systemic disorders
Subjects taking any other medicine for mandala kushtha  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of change in PASI score   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of change in classical sign and symptoms of mandala kushtha   30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/11/2023 
Date of Study Completion (India) 20/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not any  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Brief summary
Short description of the primary purpose of the protocol, including the brief statement of the study hypothesis. Include publication details.
(link/reference), if any NEED OF STUDY:
 Because of the high prevalence of psoriasis, lots of Research works have already been done on its management in both allopathy and Ayurveda fields and lots of them are still going on. Each science has its own claims over the management and success rate.
 The Allopathic medicine have some limitations and certain side effects as a Hepatotoxicity, Renal failure etc.
 Allopathic drugs basically involve steroids which are known for their long-term side effects and withdrawal effects.
 To develop a more effective and validated treatment for the betterment of the patients is the responsibility and challenge for Ayurveda practitioners.
 Literary meaning of Kosthshuddhi can be correlated with internal cleaning of body. It is one of the prime and important factors for absorption and assimilation of any substance through intestinal mucosa.
 Ayurveda believes in internal cleaning through drug or therapy, after internal cleaning impact of disease is decreased and action of drug is increased. Keeping above fact in mind Hypothesis was generated and study is planned.
SELECTION OF DRUG:
 Trivrit has been mentioned as the drug giving Sukhvirechna and used in treatment of Kapha and Pitta predominant diseases. Since in this study Kosthashuddhi is to be done, in order to not cause any huge discomfort to the patient and Mandala Kushtha is a Kapha predominant disease Trivrit has been opted as the choice of drug.
 There are a different Kalpanas mentioned in different Ayurvedic classics. Among them, Vati Kalpana is being a easy palatable form and here an attempt is made to assess the effect of Kosthashuddhi in Mandala Kushtha by administering Trivrit Ghanavati.
AIM:
To evaluate the Kosthashuddhi effect of Trivrit Ghanavati in Mandala Kushtha.
OBJECTIVES:
• To determine more clear vision on Kostha specially on Kosthashuddhi.
• To study the pathophysiology of Mandala Kushtha.
• To study the effect of Lelitak Prayog in Mandala Kushtha.
• To compare the effect of Trivrit Ghanavati and Lelitak Prayog in Mandala Kushtha.
STATEMENT OF HYPOTHESIS :
Null hypothesis(H0)
There is no effect of Kosthashuddhi by using Trivrit Ghanavati in Mandala Kushtha.
Alternative Hypothesis(H1)
There is effect of Kosthashuddhi by using Trivrit Ghanavati in Mandala Kushtha.
ASSESSMENT CRITERIA:
• Kosthshuddhi Assessment Questionare
• Ayurvedic Symptom Score
• Psoriasis Area and Severity Index (PASI Score)
INVESTIGATIONS:
• SGOT
• SGPT
• ESR
Pre and post treatment blood investigations will be done in all subjects.
 FOLLOW UP:
Primary assessment to be done at baseline screening visit. Regular assessment will be done after every 15 days.

 
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