| CTRI Number |
CTRI/2022/02/040579 [Registered on: 24/02/2022] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
study to find abortion as a cause of Amavata (Rheumatoid arthritis) |
|
Scientific Title of Study
|
Case control study on association of Aamvata with abortion |
| Trial Acronym |
|
|
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 |
Ph.D. Scholar |
| Affiliation |
Guru Ravidas Ayurved University Punjab, |
| Address |
P.G.Dept.of Roga Nidana evum Vikriti Vigyana,
Chaudhary Brahm Prakash Ayurved charak sansthan,
Khera Dabar, Najafgarh.
New Delhi.
South West
DELHI
110073
India |
| Phone |
8588943505 |
| Fax |
|
| Email |
umeshsapra123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rakesh Sharma |
| Designation |
President BERISM |
| Affiliation |
National commission for Indian system of Medicine |
| Address |
National commission for Indian system of medicine,
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi.
South West
DELHI
110058
India |
| Phone |
9814779242 |
| Fax |
|
| Email |
president.berism@ncismindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Kumar Sapra |
| Designation |
Ph.D. Scholar |
| Affiliation |
Guru Ravidas Ayurved University Punjab, |
| Address |
P.G.Dept.of Roga Nidana evum Vikriti Vigyana,
Chaudhary Brahm Prakash Ayurved charak sansthan,
Khera Dabar, Najafgarh.
New Delhi.
South West
DELHI
110073
India |
| Phone |
8588943505 |
| Fax |
|
| Email |
umeshsapra123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan , Khera Dabar, New Delhi -73. |
|
|
Primary Sponsor
|
| Name |
Government of NCT of Delhi |
| Address |
Chaudhary Brahm Prakash Ayurved charak sansthan,
Khera Dabar,
New Delhi-110073 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Guru Ravidas Ayurved University Punjab |
VPO.Kharkan,Una Road, Hoshiarpur, Punjab. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Umesh Kumar Sapra |
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN, NEW DELHI |
ROOM NO-214
DEPARTMENT OF ROG NIDAN EVAM VIKRITI VIGYANA
South West
DELHI |
8588943505
umeshsapra123@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 |
| Healthy Human Volunteers |
apparently healthy females |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients between age group of 21-65 years.
2. Diagnosed patients of Rheumatoid Arthritis as per 2016 EULAR and ACR revised criteria.
3. Patients having Samanayalakshana and Pravridhalakshana of Amavata as per Madhavanidana.
4. Patients willing to give consent for the study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women and lactating mother. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out association of abortion in Rheumatoid arthritis patients and its severity on DAS-28 Scale at the time of filling of Case report form (CRF) .
|
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. RA Factor Parameter will be assessd at the time of enrollement of the patients.
2. Functional parameters like Foot pressure,Grip strength and walking time will be assessed at the time of filling of case report form (CRF) on enrollement in the study. |
9 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2022 |
| Date of Study Completion (India) |
24/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The results of the study will be published in high indexed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Clinically diagnosed patients of Rheumatoid Arthritis and apparently healthy females will be enrolled for study from OPD and IPD of Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh, New Delhi. Screening of patient will be carried out as per subjective and objective assessment criteria to diagnose Aamvata (Rheumatoid Arthritis). After initial screening and assessment, the eligible patients will be enrolled in study and randomly divided into two groups.Clinically diagnosed patients of Rheumatoid Arthritis and apparently healthy females will be enrolled for study from OPD and IPD of Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh, New Delhi. Screening of patient will be carried out as per subjective and objective assessment criteria to diagnose Aamvata (Rheumatoid Arthritis). After initial screening and assessment, the eligible patients will be enrolled in study and randomly divided into two groups.
Grouping: Total 100 number of female patients randomly enrolled in the study and divided into two groups, 50 numbers of patients in each group. Group A: 50 female patients of Rheumatoid Arthritis. Group B: 50 apparently healthy females. Both seropositive and seronegative patients of Rheumatoid Arthritis will be taken. Patients of RA will be included in group A and apparently healthy females will be included in B groups as per designing of case control study. The selected patients shall undergo the series of events which includes their demographic details; informed consent about the study, a detailed history will be taken which could help in making the right diagnosis. Registration will be done and a detailed proforma will be filled as per the requirements of the study.
|