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CTRI Number  CTRI/2022/05/042516 [Registered on: 12/05/2022] Trial Registered Prospectively
Last Modified On: 19/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study of two formulations, navakashaya and vidangadi lepa in patients with vicharchika(dermatitis). 
Scientific Title of Study   An open label, single arm clinical study to evaluate the combined effectiveness of navakashaya and vidangadi lepa in vicharchika (Dermatitis). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dija T Lawrence 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka 
Address  Department of Kayachikitsa Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India
Hassan
KARNATAKA
573201
India 
Phone  8606822879  
Fax    
Email  lawrencedija8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Girish K J 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital 
Address  Department of Kayachikitsa Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India
Department of Kayachikitsa Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India
Hassan
KARNATAKA
573201
India 
Phone  9448646855  
Fax    
Email  girideepa@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Girish K J 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital 
Address  Department of kayachikitsa Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,BM Road,Thanniruhalla, Hassan-573201,Karnataka,India
Department of kayachikitsa Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,BM Road,Thanniruhalla, Hassan-573201,Karnataka,India
Hassan
KARNATAKA
573201
India 
Phone  9448646855  
Fax    
Email  girideepa@yahoo.co.in  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan-573201, Karnataka, India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,BM Road,Thanniruhalla, Hassan-573201,Karnataka,India 
Type of Sponsor  Private 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 Dija T Lawrence  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan,Karnataka- 573201
Hassan
KARNATAKA 
8606822879

lawrencedija8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheswara College Of Ayurveda and Hospital, Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: NAVAKASHAYA, Reference: CHAKRADATTA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 45(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects suffering with Vicharchika up to 1 year of chronicity
2. Subjects of either gender, aged between 18-70 years
3. Subjects willing to participate in the study and ready to sign informed consent form 
 
ExclusionCriteria 
Details  1. Subjects with uncontrolled diabetes mellitus
2. Pregnant and lactating women
3. Subjects with impaired cardiac, renal, and hepatic functions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Itching sensation ( Kandu)
2.Blackish brown discoloration (Shyava Varna)
3.Papule (Pidaka)
4. Excessive exudation (Bahu Srava )
EASI scale 
30 days 
 
Secondary Outcome  
Outcome  TimePoints 
QUALITY OF LIFE  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)   15/05/2022 
Date of Study Completion (India) 19/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 19/12/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Vicharchika is a type of kshudra kushta. It is characterized by, kandu (itching sensation), Bahu Srava (excessive exudation), Shyava Varna (blackish brown discoloration) and Pidaka (Papule). It is similar to Dermatitis (eczema), which refers to a heterogeneous group of disorders that share similarities in clinical appearance and histopathologic findings, but may have different etiologies. Acute dermatitis often appears vesicular (like water boiling on the skin), whereas chronic dermatitis may be red, scaly, and lichenified. Pruritus is a common symptom of all types of dermatitis.

Dermatitis was estimated to affect 245 million people globally in 2015, or 3.34% of the world population. About 10-20% of the general practice includes the patients suffering from skin disorders and Eczema accounts for a very large proportion of all the skin diseases. According to Acharya Charaka, vicharchika is characterized by skin manifestation having the lakshanas kandu, pidaka, shyava Varna and bahu srava. Acharya Charka mentioned the predominance of kapha dosha in vicharchika.

This study is intended to evaluate the effectiveness of Navakashaya internally, indicated in kushta chikista and Vidangadi Lepa externally. Ingredients of Navakashya possess tikta rasa, laghu ruksha guna, ushna virya, katu vipaka, kushtagna properties which are opposite to the qualities of kapha. The external treatment Vidangadi lepa has properties like tikta rasa, laghu ruksha guna and kushtagna. The ingredients of both formulations are easily available. There are many shamana oushadies explained in the management of vicharchika, but there is still a need for an effective formulation. Hence this study aims at evaluating the combined effectiveness of Navakashaya internally 30 ml thrice daily, before food and Vidangadi Lepa externally once daily in day time for a period of 30 days in vicharchika. Subjects will be followed on 15 th and 30th days of treatment.

 

 

 
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