| CTRI Number |
CTRI/2020/01/022758 [Registered on: 14/01/2020] Trial Registered Prospectively |
| Last Modified On: |
14/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of Amavata (Rheumatoid Arthritis) with Tobacco use. |
|
Scientific Title of Study
|
Case Control Study on Association of Amavata with Tobacco |
| Trial Acronym |
CSAT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umesh Kumar Sapra |
| Designation |
Assistant professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Postgraduate Department of Rog Nidan Evum Vikriti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan,
Khera Dabar,Najafgarh,
New Delhi-73.
New Delhi
DELHI
110073
India |
| Phone |
8588943505 |
| Fax |
|
| Email |
umeshsapra123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Kumar Sapra |
| Designation |
Assistant professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Postgraduate Department of Rog Nidan Evum Vikriti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan,
Khera Dabar,Najafgarh,
New Delhi-73.
New Delhi
DELHI
110073
India |
| Phone |
8588943505 |
| Fax |
|
| Email |
umeshsapra123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Thakur |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Postgraduate Department of Rog Nidan Evum Vikriti Vigyan, Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi-73
New Delhi
DELHI
110073
India |
| Phone |
7827239143 |
| Fax |
|
| Email |
savithakur009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch Brahm Prakash Ayurved Charak Sansthan, New Delhi |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh, New Delhi 73 |
| Type of Sponsor |
Government medical college |
|
|
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 Savita Thakur |
Ch. Brahm Prakash Ayurved Charak Sansthan,New Delhi |
PG department of Rog Nidan,
New Delhi-110073.
South West
DELHI |
9459829009
savithakur009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female patients between age group of 35 to 65 years.
2.Diagnosed patients of Rheumatoid Arthritis as per ACR/EULAR criteria.
3.Patients having samanayalakshana and pravridhlakshana of Amavata as per Madhava Nidana.
4.Patient willing to give consent for the study.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from respiratory disorders.
Pregnant women and lactating mother. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain the association of tobacco use in Amavata (Rheumatoid Arthritis) patients |
06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the new etiological factors in the patients of Amavata (Rheumatoid Arthritis) |
6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2020 |
| Date of Study Completion (India) |
31/05/2021 |
| 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
|
The data will be published in high index peer review journals. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Amavata (Rheumatoid Arthritis ) is a chronic degenerative disease of connecting tissue mainly involving the joints. Swelling and pain in multiple joints are the main features. There are many etiological factors causing the disease Amavata (Rheumatoid Arthritis) but nowadays tobacco being commonly used may be the causative factor of Amavata (Rheumatoid Arthritis) In this case control study 200 diagnosed patients of Amavata (Rheumatoid Arthritis) who is fulfilling the inclusion criteria will be selected to assess . Duration of this study will be 6 months. Null Hypothesis- Tobacco is not an etiological factors in the patients of Amavata (Rheumatoid Arthritis) Alternate Hypothesis- Tobacco is an etiological factors in the patients of Amavata (Rheumatoid Arthritis) Data will be statistically analyzed at the end of the study by using Odds ratios. The data will be published in high index peer review journals. |