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CTRI Number  CTRI/2021/12/038806 [Registered on: 21/12/2021] Trial Registered Prospectively
Last Modified On: 31/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To Evaluate Safety and Efficacy of Pathadi Ghanavati and Pathadi Oil in Psoriasis 
Scientific Title of Study   A Single Arm Clinical Trial of Pathadi Ghanavati and Pathadi Oil in Psoriasis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rupali Ramadas Patil 
Designation  Assistant Professor Department of Kayachikitsa 
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical College Ashta, Sangli 
Address  Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College and Postgraduate Research center, Ashta,Sangli

Sangli
MAHARASHTRA
416301
India 
Phone  9225633321  
Fax    
Email  rpcoolrupali@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr D G Dipankar 
Designation  Professor Department of Kayachikitsa 
Affiliation  Dr D Y Patil College of Ayurved and Research Center, pimpari, Pune 
Address  Department of Kayachikitsa Dr D.Y.Patil College of Ayurved and Research center,Pimapari,Pune-18

Pune
MAHARASHTRA
411018
India 
Phone  9822279321  
Fax    
Email  drdgdipankar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rupali Ramadas Patil 
Designation  Assistant Professor Department of Kayachikitsa 
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical College Ashta, Sangli 
Address  Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College and Postgraduate Research center, Ashta,Sangli

Sangli
MAHARASHTRA
416301
India 
Phone  9225633321  
Fax    
Email  rpcoolrupali@gmail.com  
 
Source of Monetary or Material Support  
Dr D. Y. Patil College of Ayurved and Research center, Pimpari, Pune-18 
Hon. Shri. Annasaheb Dange Ayurved Medical College & Post Graduate Research Center, Ashta, Tal Walwa Dist Sangli,416301 Sangli 
 
Primary Sponsor  
Name  HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE AND POSTGRADUATE CENTER ASHTA SANGLI 
Address  Department Kayachikitsa Hon. Shri. Annasaheb Dange Ayurved Medical College & Post Graduate Research Center, Ashta, Tal Walwa Dist Sangli,416301 Sangli Maharashtra 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTER PIMPARI PUNE  Department Kayachikitsa Dr D Y Patil College of Ayurved and Research center, Pimpari, Pune-18 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rupali Ranmadas Patil  Hon Shri Annasaheb Dange Ayurved Medical College and Postgraduate Research Center,Ashta,Sangli  Department Kayachikitsa OPD/IPD
Sangli
MAHARASHTRA 		 9225633321

rpcoolrupali@gmail.com 
Dr Rupali Ramadas Patil  Dr D Y Patil College of Ayurved and Research Center, Pimpari, Pune  Department Kayachikitsa OPD/IPD
Pune
MAHARASHTRA 		 9225633321

rpcoolrupali@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
Institutional Ethics Committee  Approved 
Research and Recognition 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: KITIBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Pathadi Ghanavati, Reference: Ashtang Hriday Kushta Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: Pathadi Oil, Reference: Ashtang Hriday Kushta Chikitsa, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: To be applied on the affected area
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients who are having sign and symptoms of Psoriasis
2.Patients suffering from psoriasis with less than 50% of the body surface involvement
 
 
ExclusionCriteria 
Details  1.Pregnant and lactating mothers
2.Patients having any severe systemic disorders like Diabetes Mellitus, Cancer etc.
3.Patients suffering from psoriasis with more than 50% of the body surface involvement and with other co morbidities


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in Dermatology Life Quality Index(DLQI)
2. Improvement in Signs and Symptoms of Psoriasis  		 7th Day, 14th Day,21th Day,30th Day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduction in mean Simplified Psoriasis Area and Severity Index Score (SPASI)
2. Reduction in mean Physicians Global Assessment Scale Score (PGA)
3. Reduction in mean Physicians Global Assessment and Body Surface Area Scale Score 		 7th Dya, 14th Day, 21th Day,30th Day 
 
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)   01/01/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Psoriasis is common dermatological disease affecting up to 0.09 to 11.4 % of world’s population and approximately 3% of Indian population. It is a chronic inflammatory, non communicable, disfiguring and disabling disease. It involves the skin, nails and is associated with a number of co morbidities. Psoriasis originates from the Greek word “Psora” that means “itch”.  It occurs mostly in second and fourth decade of life and affects male and female equally. The skin is largest organ of the body and is considered as “Organ of expression”. Due to disfiguring, psoriasis has a negative effect on the daily life, self confidence and self esteem. The prevalence of the psoriasis in India is increasing day by day. Increasing prevalence and its association with various co morbidities affects quality of life of patients suffering from psoriasis. So there is a need for research on various aspects such as epidemiology, etio- pathogenesis, and management. There is a large gap addressing the therapeutic aspects of the psoriasis where there is no definitive curative therapy available. Ayurveda Medicines has shown considerable effects in the Psoriasis. Thus, the present study is undertaken to evaluate efficacy of Pathadi Ghanavati and Pathadi Oil in the management of Kitibha (Psoriasis). 50 patients who are having signs and symptoms of Psoriasis as mentioned in inclusion criteria will be selected and treated with Pathadi Ghanavati internally and Pathadi Oil external application for 30 days. Assessment will be done on the basis of percentage relief in signs and symptoms of the Psoriasis. The reduction in mean score of Simplified Psoriasis Area and Severity Index, Physician’s Global Assessment Scale, Physician’s Global Assessment Scale and Body Surface Area Scale and Improvement in Dermatology Life Quality Index. Appropriate statistical tests will be applied to test the significance. Diet will be advised according to physical constitution or Prakriti to prevent recurrence of the disease.

 

 
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