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CTRI Number  CTRI/2023/10/058587 [Registered on: 12/10/2023] Trial Registered Prospectively
Last Modified On: 13/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   AYURVEDIC MANAGEMENT OF VICHARCHIKA (ATOPIC DERMATITIS) i.e. Itching, Dishcharge, Burning Sensation, Dryness, Eruption, De pigmentation, Cracks of Skin. 
Scientific Title of Study   A Clinical Study of Dushivisaari Agad and Ark Tail in Vicharchika (Atopic dermatitis). 
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 RAJESH YADAV 
Designation  PG Scholar 
Affiliation  Post Graduate Institute of Ayurved JODHPUR 
Address  PG Department of Agad Tantra, Post Graduate Institute of Ayurved JODHPUR 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  9829032128  
Fax    
Email  rajulal220550@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RITU KAPOOR 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Ayurved JODHPUR 
Address  PG Department of Agad Tantra, Post Graduate Institute of Ayurved JODHPUR 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  7976967729  
Fax    
Email  drritukapoor4@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR RITU KAPOOR 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Ayurved JODHPUR 
Address  PG Department of Agad Tantra, Post Graduate Institute of Ayurved JODHPUR 342037 342037


RAJASTHAN
342037
India 
Phone  7976967729  
Fax    
Email  drritukapoor4@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurved JODHPUR 
 
Primary Sponsor  
Name  POST GRADUATE INSTITUTE OF AYURVED JODHPUR 
Address  PG DEPARTMENT OF AGAD TANTRA, POST GRADUATE INSTITUTE OF AYURVED JODHPUR 342037 
Type of Sponsor  Government 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 RAJESH YADAV  Post Graduate Institute of Ayurved JODHPUR  PG Department of Agad Tantra, Post Graduate Institute of Ayurved JODHPUR, DSRRAU, JODHPUR 342037
Jodhpur
RAJASTHAN 		 9829032128

rajulal220550@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.SarvepalliRadhakrishnan Rajasthan Ayurved University Jodhpur, Post Graduate Institute of Ayurved, Institutional Ethics Committee  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: DUSHIVISHARI AGAD, Reference: SUSHRUT KALP, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: HONEY), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: ARK TAIL, Reference: SHARNGADHAR MADHYA KHAND, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Diagnosed Patient complaints having itching,.
2.Age between 18-50 year.
3.Patient willing to give consent for clinical trial
 
 
ExclusionCriteria 
Details  1.Endocrine disorder like diabetes mallitus, thyroid disfunction.
2.Age- below18 years and above 50 years.
3.patients who are suffering from major psychiatric disorder.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in the values of following data
CBC
ESR
LFT
KFT
blood sugar random
 		 30 days  
 
Secondary Outcome  
Outcome  TimePoints 
improvement in sign & symptoms like Kandu (itching)
Srava (discharge)
Daha (Burning Sensation)
Rukshata (Dryness/ Roughness)
Pidika (Eruption)
Vaivarnya
(De-pigmentation)
Rajya (Cracks)
 		 30 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 1/ Phase 2 
Date of First Enrollment (India)   18/10/2023 
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="0"
Months="9"
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  

STUDY DESIGN      

·       Types of study       - Open labelled clinical trial with single group.

·       Level of study         -  O.P.D. & I.P.D. UPGIAS&R, DSRRAU JODHPUR and other   registered hospital

·       Number of groups   -  One

·       Sample size             -   30

·       Primary purpose      -  Efficacy and safety

·       End point                -  Therapy

 DRUG AND POSOLOGY

Patient

30

Treatment Modality

Dose

Duration

Dushivisaari Agad

3gms BD with honey

30 Days

Ark  Tail

For local application.

30 Days

 FOLLOW UP STUDY

·       After completion of the trial, the case will be followed every 15 days interval for 30 days.

·       Improvement and other effect will be noted.

·       Laboratory investigations will be repeated if seemed necessary

 
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