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CTRI Number  CTRI/2023/01/049145 [Registered on: 23/01/2023] Trial Registered Prospectively
Last Modified On: 18/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Randomized comparative clinical study]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomized comparative clinical trial to study the effects of Aragvadha Taila over Durvadya Taila along with Vidangadi Churna in patients of Eczema 
Scientific Title of Study   A Randomized comparative clinical study to assess the efficacy of Aragvadha Taila over Durvadya Taila along with Vidangadi Churna in the management of Vicharchika  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Athani Sangita Revansidha 
Designation  BAMS PG SCHOLAR 
Affiliation  BLDEAs AVS Ayurveda Mahavidylaya Hospital and Research Centre Vijayapura-586109 Karnataka India  
Address  Dr Athani Sangita Revansidha PG Scholar,Department of kayachikitsa, BLDEAs AVS Ayurveda mahavidyalaya Hopital and research Centre Vijaypura-586109 Karnataka India

Bijapur
KARNATAKA
586109
India 
Phone  9404299719  
Fax    
Email  sangeetaathani0405@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Uma A Patil  
Designation  Professor 
Affiliation  BLDEAs AVS Ayurveda mahavidyalaya Hopital and research Centre Vijaypura-586109 Karnataka India  
Address  Professor,Department of kayachikitsa, BLDEAs AVS Ayurveda mahavidyalaya Hopital and research Centre Vijaypura-586109 Karnataka India

Bijapur
KARNATAKA
586109
India 
Phone  9343877670  
Fax    
Email  umaaru01@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Athani Sangita Revansidha 
Designation  BAMS PG SCHOLAR 
Affiliation  BLDEAs AVS Ayurveda mahavidyalaya Hopital and research Centre Vijaypura-586109 Karnataka India 
Address  Dr Athani Sangita Revansidha PG Scholar,Department of kayachikitsa, BLDEAs AVS Ayurveda mahavidyalaya Hopital and research Centre Vijaypura-586109 Karnataka India

Bijapur
KARNATAKA
586109
India 
Phone  9404299719  
Fax    
Email  sangeetaathani0405@gmail.com  
 
Source of Monetary or Material Support  
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [Othe[Non Sponsored Study, Academic Dissertation]] 
 
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 Athani Sangita Revansidha  BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research centre, Vijayapura-586109  Kayachikitsa 10,BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research centre, Vijayapura-586109
Bijapur
KARNATAKA 		 9404299719

sangeetaathani0405@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:L20-L30||Dermatitis and eczema. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: Charaka Sutra Sthana , Procedure details: Application of Durvadya Taila over affected area only 2 times/day )
(1) Medicine Name: VIDANGADI CHURNA , Reference: Yoga Ratnakar , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 6 Weeks
2Intervention ArmProcedure-lepa, लेप (Procedure Reference: Charaka Sutra Sthana , Procedure details: Application of Aragvadha Taila over the affected area only 2 times/day)
(1) Medicine Name: VIDANGADI CHURNA , Reference: Yoga Ratnakar , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 6 Weeks
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects with the classical signs and symptoms of Vicharchika kushta like Kandu, Pidaka, Shyavavarna, Bahusrava.

-irrespective of gender, religion, occupation, economic status, food habits and chronicity will be selected.
 
 
ExclusionCriteria 
Details  -The subjects suffering from other severe skin diseases and systemic disorders.

- Pregnant women and lactating mother.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduces itching  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduces lesion, inflammation, redness, discharge  45 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   12/06/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study is randomized comparative clinical study to asses the efficacy of Aragvadha taila over Durvadya taila along with Vidangadi churna in the management of Vicharchika that will be conducted in BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research Centre, Vijayapura-586109 Karnataka, India.  
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