FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/08/004917 [Registered on: 22/08/2014] Trial Registered Prospectively
Last Modified On: 22/08/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the efficacy of Ayurvedic medicines Kaisora Guggulu and Madhusnuhi rasayan in the treatment of Gout, a condition associated with painful joints and raised blood levels of uric acid. 
Scientific Title of Study   THERAPEUTIC EVALUATION OF KAISORA GUGGULU AND MADHUSNUHI RASAYANA IN VATARAKTA (GOUT) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PURNENDU PANDA 
Designation  RESEARCH OFFICER (AYURVEDA) 
Affiliation  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT 
Address  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT, BHARATPUR, BHUBANESWAR, ODISHA
BHARATPUR, BHUBANESWAR, ODISHA
Khordha
ORISSA
751003
India 
Phone  9777852889  
Fax  0674-2386435  
Email  pandapurnendu02@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  PURNENDU PANDA 
Designation  RESEARCH OFFICER (AYURVEDA) 
Affiliation  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT 
Address  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT, BHARATPUR, BHUBANESWAR, ODISHA
BHARATPUR, BHUBANESWAR, ODISHA
Khordha
ORISSA
751003
India 
Phone  9777852889  
Fax  0674-2386435  
Email  pandapurnendu02@yahoo.com  
 
Details of Contact Person
Public Query  
Name  PURNENDU PANDA 
Designation  RESEARCH OFFICER (AYURVEDA) 
Affiliation  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT 
Address  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT, BHARATPUR, BHUBANESWAR, ODISHA
BHARATPUR, BHUBANESWAR, ODISHA
Khordha
ORISSA
751003
India 
Phone  9777852889  
Fax  0674-2386435  
Email  pandapurnendu02@yahoo.com  
 
Source of Monetary or Material Support  
CENTRAL COUNCIL OF RESEARCH IN AYURVEDIC SCIENCES, NO 61-65, INSTITUTIONAL AREA,JANAKPURI, NEWDELHI-110058 
 
Primary Sponsor  
Name  CENTRAL COUNCIL OF RESEARCH IN AYURVEDIC SCIENCES JANAKPURI NEWDELHI 
Address  CENTRAL COUNCIL OF RESEARCH IN AYURVEDIC SCIENCES, NO 61-65, INSTITUTIONAL AREA,JANAKPURI, NEWDELHI-110058 
Type of Sponsor  Research institution and hospital 
 
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 PURNENDU PANDA  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT,  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT,ROOM-17,A,Unit Of CCRAS, BHARATPUR, BHUBANESWAR
Khordha
ORISSA 		 0674-2386702
0674-2386702
pandapurnendu02@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
EC-NRIADD-BHUBANESWAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patient suffering from joint pain with serum uric acid more than 7mg/dl,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KAISORA GUGGULU AND MADHUSNUHI RASAYANA   Kaishora Guggulu-1gm,BDS Rute of admnistration-Oral Madhusnuhi Rasayana-10gm,BDS Rute of administration-oral Duration of therapy-12 weeks with two month followup 
Comparator Agent  NIL  No  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  FULFILLING THE DIAGNOSTIC CRITERIA AS RECOMMENDED BY THE AMERICAN COLLEGE OF RHEUMATOLOGY (1977) 
 
ExclusionCriteria 
Details  PATIENTS WITH TRAUMA, FRACTURE, HEART DISEASE, MALIGNANCY, HYPO-HYPER THYROIDISM, DRUG ABUSERS, PREGNANT, LACTATING WOMEN AND ANY OTHER CONDITION WHICH THE PRINCIPAL INVESTIGATOR THINKS MAY JEOPARDIZE THE STUDY. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
MEAN PERCENTAGE DECREASE IN SERUM URIC ACID LEVEL FROM THE BASELINE TO THE END OF THE STUDY.   Total Study Period : 24 months
Pre-trial preparatory period:
 Recruitment of staff/Literature survey/ Screening
of patients/Procurement of medicine etc. : 3 months
 Washout Period (if required) : 02 weeks
 Recruitment patients/follow ups/ data recording : 18 months
 Data analysis/report preparation/ submission : 03 months
 Treatment Period : 12 weeks
 Follow-Up Period : 02 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
IMPROVEMENT IN SF-36 HEALTH SURVEY SCORE, PATIENTS GLOBAL ASSESSMENT PAIN VISUAL ANALOGUE SCALE.    Total Study Period : 24 months
Pre-trial preparatory period:
 Recruitment of staff/Literature survey/ Screening
of patients/Procurement of medicine etc. : 3 months
 Washout Period (if required) : 02 weeks
 Recruitment patients/follow ups/ data recording : 18 months
 Data analysis/report preparation/ submission : 03 months
 Treatment Period : 12 weeks
 Follow-Up Period : 02 weeks
 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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 3 
Date of First Enrollment (India)   01/10/2014 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Kaishora Guggulu and Madhusnuhi Rasayana (AFI:Part-I/API(formulation):Part-II ) will taken for the trail because both the drugs are indicated for disease Vatarakta. The drugs like Guggulu,Guduchi,Gandhaka,Madhusnuhi etc are the ingredients of theses two  formulations.

It is  evidendance that Guduchi is the drug of choice for Vatarakta and is a magnificent Rasayana,  Rakta Dosha and Daha Nasaka (Nighantu ratna kara, Raja nighantu). Madhusnuhi has the quality of Vatavyadhi Nashana (Bhavaprakasha), Rasayana, Rakta Dosha Nashana  and is indicated in Dhatu Kshaya (Nighantu Ratnakara). Guggulu is Rasayana and Vata Dosha Nasaka (Bhava Prakasha).The use of Kaishora Guggulu is a optimum selection for the management of Vatarakta (AYU, oct-Dec-2010,Vol-31,issue-4). Smilax china L.(Madhusnuhi) exhibits anti-hyperuricemic and nephroprotective activity in hyperuricemic animals (Journal of Ethnopharmacol, May 2011,135(2); pg. 399-405) 

 
Close