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CTRI Number  CTRI/2022/10/046285 [Registered on: 07/10/2022] Trial Registered Prospectively
Last Modified On: 24/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Jalaukaavacharana, Rasnadi Pradeha and Gorakhmundi Churna on Vatarakta W.S.R. Gouty Arthritis 
Scientific Title of Study   A Clinical study on Jalaukaavacharana, Rasnadi Pradeha and Gorakhmundi Churana in the management of Vatarakta W.S.R. to Gouty Arthritis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suresh Kumar 
Designation  MS Scholar 
Affiliation  Madan Mohan Malviya Government Ayurved College 
Address  PG Department of Shalya Tantra Madan Mohan Malviya Government Ayurved College Ambamata Scheme Radaji Circle Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9782622428  
Fax    
Email  prajapatsuresh322@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Namo Narayan Meena 
Designation  MD (Ayu.) Associate Professor 
Affiliation  Madan Mohan Malviya Government Ayurved College 
Address  PG Department of Shalya Tantra Madan Mohan Malviya Government Ayurved College Ambamata Scheme Radaji Circle Udaipur Rajasthan

Udaipur
RAJASTHAN
313001
India 
Phone  9928871125  
Fax    
Email  drnamorajat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Namo Narayan Meena 
Designation  MD (Ayu.) Associate Professor 
Affiliation  Madan Mohan Malviya Government Ayurved College 
Address  PG Department of Shalya Tantra Madan Mohan Malviya Government Ayurved College Ambamata Scheme Radaji Circle Udaipur Rajasthan


RAJASTHAN
313001
India 
Phone  9928871125  
Fax    
Email  drnamorajat@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Government Ayurved College 
 
Primary Sponsor  
Name  Madan Mohan Malviya Government Ayurved College 
Address  Ambamata Scheme Radaji Circle Udaipur Rajasthan 313001 
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 Suresh Kumar  Madan Mohan Malviya Government Ayurved College  OPD NO. 1 PG Department of Shalya Tantra Associated Hospitals of Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan 313001
Udaipur
RAJASTHAN 		 9782622428

prajapatsuresh322@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:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: Charaka chikitsa esthan 29/36, Procedure details: Local application of jalauka over affected area. Total 4 sittings will be given at 7 day interval for 4 weeks.per sitting bloodletting volume will be approximately 10-20 ml.)
(1) Medicine Name: Gorakhmundi churana, Reference: Chakradatta vataraktaadhikar 23/6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 4 Weeks
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: charaka sutra 3/22, Procedure details: Daily local application of lepa for four weeks)
(1) Medicine Name: Gorakhmundi churna, Reference: chakradatta vataraktaadhikar 23/6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 4 Weeks
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients willing to participate in trial

2. Patients who are having with the classical signs and symptoms of Vatarakta

3. Patient of Vatarakta having serum uric acid more than normal value in both gender
 
 
ExclusionCriteria 
Details  1. Patients not willing for the trial.

2. Any other inflammatory joint disorder like RA, tubercular arthritis etc.

3. Patients suffering from chronic respiratory, cardiac, hepatic and hormonal diseases.

4. Patients having malignant disorder.

5. Any other patient considered unfit for inclusion in criteria 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To mild relief in pain and tenderness of vatarakta(gout).
 		 4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. To reduction in sign and symptoms of vatarakta.

2.To decrease level of the uric acid in the blood. 		 1st Week, 2nd Week, 3rd Week, 4th week 
 
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   N/A 
Date of First Enrollment (India)   15/10/2022 
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="0"
Days="28" 
Recruitment Status of Trial (Global)   Not Applicable 
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   It is a Clinial study on Jalaukaavacharana, Rasnadi Pradeha and Gorakhmundi churana in the management of Vatarakta w.s.r. to gouty arthritis. It is randomised, parellel group, two arm trial. In this group  A (15 patients) is administered with Jalaukaavacharana and Gorakhmundi churana, group B (15 patients) will treated with Gorkhmundi churana and local application of Rasnadi Pradeha. 
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