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CTRI Number  CTRI/2021/01/030491 [Registered on: 15/01/2021] Trial Registered Prospectively
Last Modified On: 14/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Ghan vati]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of efficacy of Nishadi Ghana Vati and Karanja tail local application in skin disease 
Scientific Title of Study   Randomized controlled clinical study to evaluate the efficacy of Nishadi Ghana Vati and Karanja Tail local application in the management of Vicharchika with special reference to Eczema 
Trial Acronym  RCTNK 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisa Singh 
Designation  PG SCHOLAR 
Affiliation  Government Ayurved College, Vazirabad, Nanded 
Address  Kayachikitsa Department, Government Ayurved College, Vazirabad, Nanded, Maharashtra India

Nanded
MAHARASHTRA
431601
India 
Phone  8339065877  
Fax    
Email  manisasingh688@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mangesh Nalkande 
Designation  Assistant Professor 
Affiliation  Government Ayurved College, Vazirabad, Nanded 
Address  Kayachikitsa Department, Government Ayurved College, Vazirabad, Nanded, Maharashtra India

Nanded
MAHARASHTRA
431601
India 
Phone  9766694490  
Fax    
Email  mwnalkande@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mangesh Nalkande 
Designation  Assistant Professor 
Affiliation  Government Ayurved College, Vazirabad, Nanded 
Address  Kayachikitsa Department, Government Ayurved College, Vazirabad, Nanded, Maharashtra India


MAHARASHTRA
431601
India 
Phone  9766694490  
Fax    
Email  mwnalkande@gmail.com  
 
Source of Monetary or Material Support  
Own funded,Kayachikitsa Department , Government Ayurved College , Vazirabad,Nanded 
 
Primary Sponsor  
Name  Manisa Singh 
Address  PG Kayachikitsa Department, Government Ayurved College, Vazirabad,Nanded 
Type of Sponsor  Other [Self] 
 
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 
Manisa Singh  Government Ayurved Hospital, Vazirabad, Nanded  OPD NO.18 Kayachikitsa Department, Government Ayurved Hospital, Vazirabad, Nanded, Maharashtra 431601 ,India
Nanded
MAHARASHTRA 
8339065877

manisasingh688@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,GAC Nanded  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Arogyavardhini Vati and Karanja tail  Arogyavardhini Vati 500mg BD orally after meal with Karanja tail for local application 
Intervention  Nishadi Ghana Vati and Karanja Tail  Nishadi Ghana Vati 500mg BD orally after meal with Karanja Tail local application for 30 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The patient will be diagnosed on the basis of Symptoms of Vicharchika(Eczema) given in Sushruta Samhita
a) Mandala (patches)
b) Atikandu (severe itching)
c) Ruja (pain)
d) Rukshata (dryness)
Patients who are co-operative and ready to give written consent
Duration of symptoms is 1 year
 
 
ExclusionCriteria 
Details  Patients having skin disorder other than eczema
Eczema with systemic illness like severe DM, IHD
Complicated or steroid dependent Eczema 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in itching, pain, dryness of lesion and decrease in size of 1 or 2 large lesions  30days 
 
Secondary Outcome  
Outcome  TimePoints 
Nishadi Ghana Vati orally with Karanja Tail local application is more effective than Arogyavardhini Vati orally with Karanja Tail local application  In 31 days 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   20/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/01/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   This study will be submitted in the form of dissertation to Maharashtra University Of Health Sciences as a part of Post Graduation course 
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, controlled clinical study of Nishadi Ghana Vati 500mg BD orally after meal with Karanja Tail local application for 30 days and follow up on 0th, 16th and 31th day.This study is conducted as PG course at single centre.The primary outcome is decrease in itching, pain, dryness of lesion and decrease in size of 1 or 2 large lesion  
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