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CTRI Number  CTRI/2024/07/071508 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of sarvakusthankush churna in vicharchika(dry excema) 
Scientific Title of Study   A randomized controlled clinical trail to study the effect of sarvakusthankush churna in vicharchika with special reference to dry eczema. 
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 Simran Madhukar Rathod  
Designation  Post Graduate Student  
Affiliation  SMBT Ayurved College and Hospital  
Address  Department of kayachikitsa SMBT Ayurved College and Hospital,Nandihills Dhamangaon Igatpuri Nashik 422403 Maharashtra India

Nashik
MAHARASHTRA
422403
India 
Phone  7218603857  
Fax    
Email  simranrathod05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mayuri S Patil 
Designation  Associate Professor  
Affiliation  SMBT Ayurved College and Hospital  
Address  Department of kayachikitsa SMBT Ayurved College and Hospital,Nandihills Dhamangaon Igatpuri Nashik 422403 Maharashtra India

Nashik
MAHARASHTRA
422403
India 
Phone  8668549430  
Fax    
Email  dr.mayuripawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Simran Madhukar Rathod 
Designation  Post Graduate Student 
Affiliation  SMBT Ayurved College and Hospital  
Address  Department of kayachikitsa SMBT Ayurved College and Hospital,Nandihills Dhamangaon Igatpuri Nashik 422403 Maharashtra India

Nashik
MAHARASHTRA
422403
India 
Phone  7218603857   
Fax    
Email  simranrathod05@gmail.com  
 
Source of Monetary or Material Support  
OPD no 10 Department of Kayachikitsa SMBT Ayurveda College and Hospital Nandihills Dhamangaon Igatpuri Nashik 422403 Maharashtra India  
 
Primary Sponsor  
Name  Dr Simran Madhukar Rathod  
Address  OPD no 10 Department of Kayachikitsa SMBT Ayurved College and Hospital Nandihills Dhamangaon Igatpuri Nashik 422403 Maharashtra India  
Type of Sponsor  Other [Private Ayurved 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 
DrSimran Madhukar Rathod   SMBT Ayurved College and Hospital   OPD no10 Department of kayachikitsa SMBT Ayurved College and Hospital
Nashik
MAHARASHTRA 		 7218603857

simranrathod05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT Ayurved College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Sarvakushtankush churna, Reference: रसरत्नसमुच्य , उत्तर अध्याय, २०, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Ghrit and madhu in unequal quantity), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Panchanimb churna, Reference: भै.र.कु . ७६-७९ , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Ghrit and madhu in unequal quantity), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient willing for clinical trail.
2. Patients of age group 18-60 years.
3. Patient with pratyatma lakshanas of vicharchika like Mandal, atikandu, (Severe
itching), ruja (pain) , rukshata(dryness).
4. Patient will be selected regardless of gender, religion and occupation
5. Pts who fulfill the criteria and take medicine with regular follow up. 
 
ExclusionCriteria 
Details  1. Pts those having skin diseases other than eczema.
2. Eczema with k/c/o systemic illness like DM, HTN, tuberculosis, pregnant women.
3. HIV, HbsAg , sero-positive patient. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in signs and symptoms of Vicharchika after injestion of Sarvakusthankush churna  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   15/08/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   In Ayurveda ‘Kushnateeti Kustham’ the disease which destroys the affected part of the body (skin) is known as Kustha. Among 18 types of Kustha, Vicharchika is classified under Kshudrakustha and Raktapradoshaj Vikara with symptoms like pain ,dryness, mild to moderate itching lesions. Among adults prevalence rate of vicharchika is 6.75% In Sarvakushtankush churna, there are three contents which mainly acts on Kushta. Psoralea corylifolia linn known as Bakuchi which very well known for its efficacy against skin disorder. In Ayurveda it is described as Kushtaghni which means useful in skin diseases. Bakuchi has raktshodhak property which means blood purifier. The other content Vitex nigandu called as Nirgundi having katu tikta kashaya rasa, laghu ruksha guna, ushna veerya and vata kapahara property. It has deepan, kushtaghna, krimighna, medhya, shothara, shulahara karma. Curculigo orchioides which also called as musli improves complexion and useful in general debility, deafness, skin diseases, impotence, jaundice. The patients within the age group of 18 to 60 years who fulfill the clinical assessment criteria for Vicharchika and having symptoms of Vicharchika. Computerized generated sampling techniques will be used. Total 60 numbers of patient will be selected and divided in to two groups, named as Group A ( trail group) and Group B(control group) . Sarvakusthankush churna trail group and Panchnimba churna control group with dose 3 gm bd with anupan Madhu and Ghrut in unequal quantity for 21 days .Observation will be done on day 0,day 7,day 14,day 21.Result of study will be drawn on basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observation and result obtained during the treatment . Summary will be drawn and whole thesis work will be summarized.
 
 
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