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CTRI Number  CTRI/2024/07/071580 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Vicharchikari Taila in treatment of Vicharchika 
Scientific Title of Study   Pharmaceutical Standardization And clinical Evaluation On Vicharchikari Taila In The Management Of Vicharchika. 
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 Palak Sharma 
Designation  MD Scholar 
Affiliation  Dept Of Rasa Shastra Postgraduate Institute Of Ayurveda Dr S R Rajasthan Ayurved University Jodhpur 
Address  Dept Of Rasa shastra Postgraduate Institute Of Ayurveda Dr S R Rajasthan Ayurved University jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9354130346  
Fax    
Email  sharmapalak0211@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  prof govind sahay shukla 
Designation  professor 
Affiliation  Postgraduate Institute Of Ayurveda 
Address  Dept Of Rasa shastra Postgraduate Institute Of Ayurveda Dr S R Rajasthan Ayurved University jodhpur
Dept Of Rasa shastra Postgraduate Institute Of Ayurveda Dr S R Rajasthan Ayurved University jodhpur
Jodhpur
RAJASTHAN
342037
India 
Phone  08769058254  
Fax    
Email  dr.govindshukla@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Palak Sharma 
Designation  MD Scholar 
Affiliation  Dept Of Rasa Shastra Postgraduate Institute Of Ayurveda Dr S R Rajasthan Ayurved University Jodhpur 
Address  Dept Of Rasa shastra Postgraduate Institute Of Ayurveda Dr S R Rajasthan Ayurved University jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9354130346  
Fax    
Email  sharmapalak0211@gmail.com  
 
Source of Monetary or Material Support  
Dr S R Rajasthan Ayurved University, Karwar, Nagaur Road, Jodhpur 
 
Primary Sponsor  
Name  Post Graduate Institue Of Ayurved, Jodhpur, Rajasthan  
Address  PGIA, Dr. S. R. Rajasthan Ayurved University, Jodhpur, Rajasthan , 342037 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Palak Sharma  Aman Medical Store, Chuli Gate, Near No.2 School, Gangapur City, Sawai Madhopur, Rajasthan , 322201 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Palak Sharma  Sanjeevani Hospital  Room No 11 PGIA Dr S R Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN 		 9354130346

sharmapalak0211@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:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vicharchikari Taila, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 30 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients 14-70 years of both sexes will be selected
2. Patients fulfilling the criteria of classical symptoms of Vicharchika like Kandu (Itching), Pidika (Papillae), Shyavavarna (Discoloration), Daha (Burning sensation), Rukshta (Dryness) and Ruja (Pain) will be selected for assessment.
3.Patients having complaints for less than 5 years.
 
 
ExclusionCriteria 
Details  1.Patients below 14 and above 70 years.
2.Patients having complaints for more than 5 year.
3.Patients having pregnancy
4.Patient having any allergic history or sensitivity will be excluded from study
5.Patient having diabetes, will be excluded from present study.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relive in classical symptoms of Vicharchika.   60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Repigmentation and decrease in relapsing lesion of atopic dermatitis.   60 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/ Phase 3 
Date of First Enrollment (India)   03/02/2025 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

   As the skin is the largest Protective organ of human body, which is related to visual clinical speciality.  The color of skin is important biologically, cosmetically and socially. It acts as an effective barrier against the entry of microbes. All the skin diseases in Ayurveda have been described under heading of ’kushtha’ which further divided into Mahakushtha and Kshudrakushtha.  Vicharchika1 is one of kshudrakushtha runs a chronic course generally considered difficult to cure and even it is cured relapse is common, it is characterized with symptoms namely Kandu (Itching), Srava (Discharge), Pidika (Vesicles), and Shyava varna (Discoloration). The clinical representation of Vicharchika in modern dermatology is Eczema. Eczema or dermatitis is pattern of inflammatory response of skin which leads to delayed type hypersensitivity mediated by Memory T lymphocyte in skin. It is characterized by redness, skin oedema, itching and dryness with possible crusting, flaking, blistering, cracking & oozing or Bleeding. According to WHO almost 900 million people in the world are affected from skin diseases. Globally, skin and subcutaneous diseases was responsible for 42·9 million (95% UI 28·6–63·4) DALYs and 4·86 billion (4·68–5·06) incident cases in 2019. Globally, atopic dermatitis2 was responsible for 7·48 million (95% UI 3·99–12·6) DALYs and 24·4 million (23·3–25·6) incident cases in 2019.

   

 Vicharchikari taila3 is a poly-herbo mineral oil described in Kushtharogadhikara of bhaishajaya ratnavali . This formulation contains 17 drugs (Kutaj and shunti ) are used two times. 14 are Herbal drugs and 3 are Minerals. This formulation will help in breaking the pathology of Vicharchika as most of the drugs are having Kaphaghna4, Kandughna, Kushthaghna, Raktaprasadak & Vranashodhak properties. According to modern pharmacology these drugs possess Antiinflammatory, Antioxidant, Anti allergic, Anti histaminic, Antibacterial, Anti fungal, Blood purifier properties that are helpful in breaking pathogenesis of Vicharchika. In present world, modern medicines available for skin diseases are mostly steroids that are harmful for patient’s health. Overuse of steroids cause side effects and can also worsen the condition of patient. So, There is a need to standardize & study clinical trial of a herbal formulation(vicharchikari taila) that can reduce symptoms as well as has no side effects.

 
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