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CTRI Number  CTRI/2019/02/017659 [Registered on: 14/02/2019] Trial Registered Prospectively
Last Modified On: 28/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to fine efficacy of two Ayurvedic drugs in the treatment of pain and swelling of joints occurring after chikungunya fever. 
Scientific Title of Study   Efficacy of Punarnava Guggulu and Sanjivani Vati in the management of Post Chikungunya Chronic Inflammatory Rheumatism -An Open Labelled Randomized Comparative Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chaitali B Kakadiya  
Designation  MD(Ayu) scholar 
Affiliation  Institute for Post Graduate Teaching & Research in Ayurveda 
Address  Department of Kayachikitsa, IPGT and RA, GAU, Jamnagar.
Department of Kayachikitsa, IPGT and RA, GAU, Jamnagar.
Jamnagar
GUJARAT
361008
India 
Phone  7046214241  
Fax    
Email  chaitali.kakadiya@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DrMandip Goyal 
Designation  Associate Professor 
Affiliation  Institute for Post Graduate Teaching & Research in Ayurveda 
Address  Department of Kayachikitsa, IPGT and RA, GAU, Jamnagar.

Jamnagar
GUJARAT
361008
India 
Phone  9998545678  
Fax    
Email  kaurmandip22@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrMandip Goyal 
Designation  Associate Professor 
Affiliation  Institute for Post Graduate Teaching & Research in Ayurveda 
Address  Department of Kayachikitsa, IPGT and RA, GAU, Jamnagar.


GUJARAT
361008
India 
Phone  9998545678  
Fax    
Email  kaurmandip22@yahoo.com  
 
Source of Monetary or Material Support  
IPGT and RA Gujarat Ayurved Univercity Jamnagar Gujarat 
 
Primary Sponsor  
Name  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  IPGT and RA Gujarat Ayurved Univercity Jamnagar Gujarat 
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 
chaitali kakadiya  IPGT and RA hospitle  Department of Kayachikitsa, opd no 13 IPGT and RA, GAU, Jamnagar.
Jamnagar
GUJARAT 
7046214241

chaitali.kakadiya@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-IPGT and RA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A920||Chikungunya virus disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Punarnava Guggulu  3 Vati (300 mg each) of Punarnava Guggulu will be given thrice a Day with warm water after meal 
Comparator Agent  Sanjivani Vati  2 Vati (125 mg each) of sanjivani vati will be given thrice a Day with warm water after meal. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Confirm case of Chikungunya fever with symptoms of pCHIK-CIR.
2.Patient willing to participate in the trial.
 
 
ExclusionCriteria 
Details  1.Age below 18 years & above 60 years.
2.Pregnant and lactating women
3. History of RA, Gout, Psoriatic arthritis, rheumatic fever, autoimmune disease, thyroid dysfunction, sarcoidosis, SLE before Chikungunya fever.
4.Patients suffering from: Malignant and accelerated hypertension, coronary artery disease, uncontrolled diabetes.
• Patient undergoing regular treatment for any other severe illness and also patients suffering from pulmonary tuberculosis, bone tuberculosis, carcinoma and HIV positive patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
efficacy  2 months
 
 
Secondary Outcome  
Outcome  TimePoints 
safety  2 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   18/02/2019 
Date of Study Completion (India) 23/01/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

This study was a randomized clinical trial to evaluate the effect of  Punarnava Guggulu and Sanjivani Vati in the management of post chikunguya chronic inflammatory rheumatism. Total 32 patients were enrolled in present study. Selected patients were divided in two group on the basis of computer generated randomisation. In this study Punarnava Guggulu was given in dose 2 tablet (300 mg each) tds after food with warm water for 2 months and Sanjivni Vati was 2 tablet (125mg each) tds after food with warm water for 2 months,  Patients of both the group were also given two sitting of Sarvanga Vashpa Swedana, each sitting of 6 days in the morning with Dashmulakwatha during initial two week of  treatment.   Patients were allowed to use concomitant drugs during the course of trial.   Follow up will be carried out at 7 days interval for 1 month . Assessment was made on the basis of subjective criteria like chief complaints and associated complaints and objective criteria like ESR, CRP(Quantitative), VAS score, RAPID3 score and disability index. after applying statistical test highly significant improvement was found in both the group in subjective criteria. In objective criteria, statistically significant decrease was found in both the groups. by comparing two groups, statistically insignificant difference was found. Thus alernative hypothesis is rejected and null hypothesis i.e. "Punarnava Guggulu and Sanjivani Vati are effective in the management of post chikungunya chronic inflammatory rheumatism when given orally along with Sarvanga Vashpa Swedana". No any adverse drug reaction was found in both of the groups.

 
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