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CTRI Number  CTRI/2023/05/052913 [Registered on: 19/05/2023] Trial Registered Prospectively
Last Modified On: 18/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of drug Dhaturadi Tail on patients affected on Vipadika local  
Scientific Title of Study   An Experimental Dermal Safety Study of Dhaturadi Tail in Rats and it’s Clinical Efficacy in Vipadika Through Local Application 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suman Chandra 
Designation  P.G.Scholar 
Affiliation  Shri N.P.A.Government Ayurveda College Raipur Chhattisgarh  
Address  Department of Agadtantra Evum Vidhi Ayurveda 1st floor ,Shri N.P.A. Government Ayurveda college. G.E.Road Raipur Chhattisgarh
Shri Khudada Dungaji Government Ayurveda Hospital G.E.Road Raipur Chattisgarh
Raipur
CHHATTISGARH
492010
India 
Phone  9753318989  
Fax    
Email  sc17101994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSRInchulkar  
Designation  Prof.and HOD Agadtantra Evum Vidhi Ayurveda Department  
Affiliation  Shri N.P.A.Government Ayurveda College Raipur Chhattisgarh  
Address  Department of Agadtantra Evum Vidhi Ayurveda 1st floor ,Shri N.P.A. Government Ayurveda college. G.E.Road Raipur Chhattisgarh
Shri N.P.A. Government Ayurveda college. G.E.Road Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India 
Phone  9425215318  
Fax    
Email  sinchulkar@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr SRInchulkar  
Designation  Prof.and HOD Agadtantra Evum Vidhi Ayurveda Department  
Affiliation  Shri N.P.A.Government Ayurveda College Raipur Chhattisgarh  
Address  Department of Agadtantra Evum Vidhi Ayurveda 1st floor Shri N.P.A. Government Ayurveda college. G.E.Road Raipur Chhattisgarh
Shri N.P.A. Government Ayurveda college. G.E.Road Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India 
Phone  9425215318  
Fax    
Email  sinchulkar@yahoo.co.in  
 
Source of Monetary or Material Support  
ShriN.P.A.government Ayurveda College Raipur Chattisgarh 492010 
 
Primary Sponsor  
Name  Shri n.p.a.Government Ayurveda college Raipur C.G. India  
Address  Shri n.p.a.Government Ayurveda college Raipur C.G. G.E. Shri n.p.a.Government Ayurveda college Raipur C.G. India Road Raipur Chhattisgarh 492010  
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 Suman chandra  Shri NPA government Ayurveda college, Raipur   Department of Kayachikitsa OPD 2 shri khudad Dungaji goverment ayurveda Hospital raipur Chattisgarh
Raipur
CHHATTISGARH 
9753318989

sc17101994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, (2) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VIPADIKA, (3) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VIPADIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: dhaturadi tail, Reference: Yogaratnakar, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Nil
Intervention  Dhaturadi Tail  Composition of Dhaturadi Tail-1.Dhatura beej 2.Mankand 3. Katu Tail. It cures vipadika. Duration-30 days. 
Comparator Agent  Nil  Nil  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed patients with clinical features of Vipadika according to Ayurveda and modern 
 
ExclusionCriteria 
Details  Patients below 18 yr age and above 60 yr age, Having chronic skin manifestation like SLE. Patients having complaints for more than 5 yr. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of symptoms of Vipadika
Pain-pada sphutana, Vedana 
First follow up after 7days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in symptoms - raga toda Kandu  30 days 
 
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   Phase 2 
Date of First Enrollment (India)   01/06/2023 
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="5" 
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  
Avurveda is the traditional, ancient Indian system of health science. Ayurveda is a science of
life and aim of the Ayurveda is to maintain the health of the healthy person and cure the diseases. All skin diseases in the Ayurveda have been considered under the heading of Kustha.
VIPADIKA in one of such diseases which have been included under the heading of Kshudra-kustha. Vipadika skin disease is included in Kshudra-kushtha with Vata-Kaphadosha involvement and it is characterized by Pani-Pada Sphutana (fissure in palm and soles) andTivravedana’ (severe pain) Vipadika is correlated with palmer planter psoriasis which is a chronic skin disease which mainly affects the palms and sole region. Especially in palmer-planter psoriasis painful fissures and bleeding is more common. In chalking out a practical line of treatment, we need to understand that in between the hectic schedule of today’s life, there is a need of simple and effective remedy in order to regain the texture of hand and foot cosmetically and gain relief from the symptoms, external applicationhave excellent results. Acharya Yogratnakar has mentioned Dhaturadi Tail in themanagement of Vipadika consisting three drug which are having properties of snehana, ropan, kandughna, shothahar, kusthaghna and other properties. The main constituent of the Dhaturadi Tail is "Dhatura Beej" Keeping all these points, Dhaturadi Tail is planned, to evaluate for its toxicity in wistar albino rats for the safety purposes & if no toxicity is found in pre clinical experimental
studies then its clinical efficacy will be observed in Vipadika.

NEED OF STUDY-
Skin is the largest organ of the body which first exposed with the environment agents likephysical chemical and biological agent. Skin plays chief role in maintaining barrier betweeninternal and external environment of human body. The healthy skin is the primary requirement for the beauty as well as attractive personality. Vipadika is one of such disease which has been included under the heading of Kshudra- kustha. Main symptoms of Vipadika are cracks (sphutana) either in palms or soles or in both with severe pain. The pain present of Vipadika is so intense that it severely afflicts the qualityof life of the patients. In spite it being a minor condition it stultifies the routine work of patients, they make the patient worried due to its external appearance. And severe itching or burning or oozing disturbs his/her day to day life. It also gives mental agony as a cosmetic problem. In chalking out a practical line of treatment, we need to understand that in between the hectic schedule of today’s life, there is a need of simple and effective remedy in order to regain the texture of hand and foot cosmetically and gain relief from the symptoms external  application have excellent results. By considering this fact, Dhaturadi tail may be better choice for the treatment of Vipadika by its snehana, ropan, vedanahar, shothahar,
kusthaghna, kandughna and others properties. Hence the present study, Dhaturadi tail isselected for VIPADIKA. It comprises as an ingredient Datura Beej, it has poisonous. property. There may be a possibility of having toxic effects to the people. Hence it feelsnecessary to plan the dermal toxicity of this oil. Therefor, toxicity of Dhaturadi tail will be evaluated in wistar albino rats for the safety purposes, If no toxicity will be observed then further clinical efficacy of the Dhaturadi Tail on Vipadika will be studied but if any toxicity occurs then the study will be stopped.


 
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