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CTRI Number  CTRI/2022/09/045971 [Registered on: 28/09/2022] Trial Registered Prospectively
Last Modified On: 21/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effect of drugs Punarnavaamrita Guggulu and Nagbala Tail in the treatment of patients with high uric acid. 
Scientific Title of Study   A CLINICAL STUDY TO EVALVUATE THE EFFICACY OF PUNARNAVA AMRITA GUGGULU AND MATRA BASTI WITH NAGBALA TAIL IN MANAGEMENT OF GAMBHEER VATARAKTA w.s.r. GOUT 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrManisha Bai 
Designation  P.G. Scholar 
Affiliation  Madan Mohan Malviya Government Ayurved College, Udaipur  
Address  P.G.Dept. of Kayachikitsa Madan Mohan Malviya Government Ayurved College Udaipur Udaipur RAJASTHAN India

Udaipur
RAJASTHAN
313001
India 
Phone  6375840967  
Fax    
Email  vikashyadav471995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrRavi Sharma 
Designation  Proffessor and HOD 
Affiliation  Madan Mohan Malviya Government Ayurved college ,Udaipur 
Address  P.G.Dept. of Kayachikitsa Madan Mohan Malviya Government Ayurved College Udaipur Udaipur RAJASTHAN India

Udaipur
RAJASTHAN
313001
India 
Phone  9414419259  
Fax    
Email  rspgkcj2015@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrRavi Sharma 
Designation  Proffessor and HOD 
Affiliation  Madan Mohan Malviya Government Ayurved college,Udaipur 
Address  P.G.Dept. of Kayachikitsa Madan Mohan Malviya Government Ayurved College Udaipur Udaipur RAJASTHAN India

Udaipur
RAJASTHAN
313001
India 
Phone  9414419259  
Fax    
Email  rspgkcj2015@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Government Ayurved college,Udaipur 
 
Primary Sponsor  
Name  Madan Mohan Malviya Government Ayurved college 
Address  Madan Mohan Malviya Government Ayurved college Radaji circle,Ambamata scheme,Udaipur 
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 
DrManisha Bai  Madan Mohan Malviya Government Ayurved college,Udaipur  OPD No:1 P.G Department of kayachikitsa Madan Mohan Malviya Government Ayurved college and Associated hospitals,Udaipur
Udaipur
RAJASTHAN 		 6375840967

vikashyadav471995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Madan Mohan Malviya Government Ayurved college,Udaipur  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: GAMBIRA-VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: chakradhutta, Procedure details: Nagbala tail will be administered per rectum at the dosage of 50 ml for 7 days.)
(1) Medicine Name: Nagbala tail, Reference: chakradhutta, Route: Rectal, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days
2Intervention ArmDrugClassical(1) Medicine Name: Punarnava amrita guggulu, Reference: chakradhutta, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Diagnosed and confirmed cases of gambheer vatarakta
2)Uric acid level more than 6mg/dl
3)Disease not more than one year 
 
ExclusionCriteria 
Details  1)Age below 30 yrs and above 70 yrs.
2)Pregnant womens and lactating mothers
3)Patients suffering from severe systemic disorders like cardiac disorders ,malignant diseases or any life threatening conditions. 
 
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)Improvement in signs and symptoms of gambheer vatarakta
2)Improvemet in uric acid level 		 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)Improvement in signs and symptoms of gambheer vatarakta
2)Improvemet in uric acid level 		 15 days,30 days and 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   N/A 
Date of First Enrollment (India)   10/10/2022 
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="2"
Days="0" 
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   This is a interventional single arm study in which punarnava amrita guggulu will be administered at the dosage of 500 mg,bid for 2 months, along with the administration of nagbala tail matra basti at the dosage of 50 ml,od for the duration of 7 days in the  40 patients suffering from gambheer vatarakta. 
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