| CTRI Number |
CTRI/2021/04/032954 [Registered on: 20/04/2021] Trial Registered Prospectively |
| Last Modified On: |
20/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL STUDY TO FIND THE EFFECT OF TWO AYURVEDIC DRUGS AMRITA GUGGULU AND RASNADASAMOOLA KWATHAM IN REDUCING DISEASE ACTIVITY IN RHEUMATOID ARTHRITIS |
|
Scientific Title of Study
|
EFFECT OF AMRITA GUGGULU AND RASNADASAMOOLA KWATHAM IN RHEUMATOID 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 Pravith NK MDAy |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Government Ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946431132 |
| Fax |
|
| Email |
drnkpravith@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravith NK MDAy |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Government Ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946431132 |
| Fax |
|
| Email |
drnkpravith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravith NK MDAy |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Government Ayurveda college Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946431132 |
| Fax |
|
| Email |
drnkpravith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Principal,Government Ayurveda college Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Dr Pravith N K |
| Address |
Associate Professor
Government Ayurveda college,
Thiruvananthapuram |
| Type of Sponsor |
Other [ Government Ayurveda College Thiruvananthapuram] |
|
|
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 |
| Anupama A S |
Government Ayurveda college Thiruvananthapuram |
Department of kayachikitsa op no: 2 Government Ayurveda College Thiruvananthapuram No. 9946431132
Thiruvananthapuram
KERALA |
7403281992
anupama.ayurvedam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M05-M14||Inflammatory polyarthropathies. Ayurveda Condition: VATARAKTAM, (2) ICD-10 Condition:M05||Rheumatoid arthritis with rheumatoid factor. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amrita Guggulu and Rasnadasamoola kwatham with eranda thaila anupana |
Amrita guggulu mentioned in yogaratnakara in Vataraktha adikarana and Rasna dasamoola kwatham mentioned in Bhaishajya ratnavali in Amavata adikarana.Rasna dasamoola kwatham is given as sachet. One sachet morning and evening with 60ml lukewarm water and 6ml eranda taila as anupana one hour before food for 30 days orally. Amrita guggulu in gutika form having 500mg weight at morning and evening with lukewarm water one hour after food for 30 days orally. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male and Female patients of age group 30-60 years, diagnosed as Rheumatoid Arthritis by satisfying the 2010 ACR diagnostic criteria. |
|
| ExclusionCriteria |
| Details |
1.Patients with major structural deformity as a complication of Rheumatoid Arthritis.
2.Patients with known history of major liver disorders, lung disorders and cardiac illness.
3.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Changes in DAS 28 scale
•Changes in grading of tenderness, morning stiffness.
•Changes in lab investigations for estimation of ESR, RA factor.
|
at baseline, 30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/04/2021 |
| 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="1"
Months="6"
Days="10" |
|
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
|
To know the effect of Amrita Guggulu and Rasnadasamoola kwatham in the management of reducing the disease activity scale and blood parameters in Rheumatoid Arthritis.The null hypothesis is Amrita Guggulu and Rasnadasamoola kwatham is not effective in Rheumatoid Arthritis and the alternate hypothesis is Amrita Guggulu and Rasnadasamoola kwatham is effective in Rheumatoid Arthritis. |