| CTRI Number |
CTRI/2022/01/039808 [Registered on: 28/01/2022] Trial Registered Prospectively |
| Last Modified On: |
29/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of life of Uthiravatha suronitham(Rheumatoid arthritis) |
|
Scientific Title of Study
|
AN ASSESSMENT OF QUALITY OF LIFE IN UTHIRAVATHA SURONITHAM(RHEUMATOID ARTHRITIS)PATIENTS REPORTING AT AYOTHIDOSS PANDITHAR HOSPITAL NATIONAL INSTITUTE OF SIDDHA A CROSS SECTIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Surya |
| Designation |
PG Scholar |
| Affiliation |
National Institute of siddha |
| Address |
Room 1 Department of Maruthuvam National Institute of Siddha
Tambaram sanatorium Kancheepuram
chennai 600047
Room 1 Department of Maruthuvam
National institute of Siddha
Tambaram sanatorium kancheepuram
chennai 600047
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8072897366 |
| Fax |
22381314 |
| Email |
suryaasaithambi1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Nalini sofia |
| Designation |
Associate proffessor |
| Affiliation |
National Institute of siddha |
| Address |
Room 1 Department of Maruthuvam National Institute of Siddha
Tambaram sanatorium Kancheepuram
chennai 600047
Room 1 Department of Maruthuvam
National institute of Siddha
Tambaram sanatorium kancheepuram
chennai 600047
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
22381314 |
| Email |
dr.h.nalinisofia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Surya |
| Designation |
PG Scholar |
| Affiliation |
National Institute of siddha |
| Address |
Room 1 Department of Maruthuvam National Institute of Siddha
Tambaram sanatorium Kancheepuram
chennai 600047
Room 1 Department of Maruthuvam
National institute of Siddha
Tambaram sanatorium kancheepuram
chennai 600047
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8072897366 |
| Fax |
22381314 |
| Email |
suryaasaithambi1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF SIDDHA |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room 1 Department of Maruthuvam National Institute of Siddha Tambaram sanatorium |
| 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 |
| Dr A Surya |
AYOTHIDOSS PANDITHAR HOSPITAL |
Room no 1 Department of Maruthuvam National Institute of Siddha Tambaram sanatorium
Kancheepuram
TAMIL NADU |
8072897366
22381314
suryaasaithambi1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 30 TO 65 Years Male Female and Transgender K/C/O Uthiravatha suronitham(Rheumatoid Arthritis)patients
with sero negative sero positive RA Lab investigations patients who are willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Age below 30 and above 65 years Patients with normal CRP Anti CCP test results Patient who are not willing to give consent form Patients defects (Osteoarthritis Psoriatic arthritis Gout arthritis) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of this study will provide validate measure of quality of life and provide a tool for improving the evaluation of siddha medications for Uthiravatha Suronitham |
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Six months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2022 |
| Date of Study Completion (India) |
20/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Rheumatoid arthritis is the most common
persistent inflammatory arthritis. The symptoms are pain, joint swelling and
stiffness affecting the small joints of the hand, feet, and wrists. Large joint
involvement, systemic symptoms and extra articular features may also occur. OBJECTIVE: To estimate the quality of life (QOL) in
Uthiravatha suronitham patients reporting at OPD of Ayothidoss Pandithar
hospital, NIS through Rheumatoid Arthritis Flare Questionnaire (RA-FQ) and to
assess the predisposing factors of Uthiravatha suronitham with respect age,
gender, chronicity of illness, personal history, occupational history, family
history, stress etc. MATERIALS AND
METHODS: This is a Hospital based cross
sectional study, included 100 Uthiravatha suronitham patients reported OPD
of ayothidoss pandithar hospital were
enrolled based on inclusion and exclusion criteria. After obtaining
informed consent form, data were collected by using Rheumatoid Arthritis Flare Questionnaire
(RA-FQ) and Beck’s Depression Inventory form to estimate the quality of life. RESULTS : In 100 Uthiravatha suronitham
patients, over all score is 42.9 in RA-FQ (Maximum 50) questionnaire. In beck’s
depression Inventory showed that 38%
patients had Moderate depression and 33% patients had Severe depression. CONCLUSION: Rheumatoid arthritis
significantly affects the quality of life of patients both physically and
mentally. |