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
|
|
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
|
|
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. |