| CTRI Number |
CTRI/2023/09/057617 [Registered on: 14/09/2023] Trial Registered Prospectively |
| Last Modified On: |
21/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
Study On Causative Agents of Amavata |
|
Scientific Title of Study
|
An Observational Study On Etiological Factors Accountable For Rheumatoid Arthritis (Amavata)
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DEVJINDER SINGH |
| Designation |
PG SCHOLAR ROGA NIDAN EVUM VIKRITI VIGYAN |
| Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS, BEHIND MANIT,KOLAR NEHRU NAGAR BYPASS ROAD, BHOPAL, MADHYA PRADESH
462003
INDIA
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
6377717847 |
| Fax |
|
| Email |
devjindersingh1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJAY SRIVASTAVA |
| Designation |
PROFESSOR AND HOD OF ROGA NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT , KOLAR NEHRU NAGAR
BYPASS ROAD ,BHOPAL BHOPAL MADHYA PRADESH 462003
INDIA
Bhopal
MADHYA PRADESH
462003
India
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425012608 |
| Fax |
|
| Email |
sanjayayurvedabhopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEVJINDER SINGH |
| Designation |
PG SCHOLAR ROGA NIDAN EVUM VIKRITI VIGYAN |
| Affiliation |
Pt KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS, BEHIND MANIT,KOLAR NEHRU NAGAR BYPASS ROAD, BHOPAL, MADHYA PRADESH
462003
INDIA
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
6377717847 |
| Fax |
|
| Email |
devjindersingh1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
|
|
Primary Sponsor
|
| Name |
Pt KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT, KOLAR NEHRU NAGAR, BYPASS ROAD,BHOPAL,MADHYA PRADESH 462003 INDIA |
| 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 DEVJINDER SINGH |
Pt KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
ROGA NIDAN EVUMVIKRITI VIGYAN
DEPARTMENT,ROOM NO. 6 SCIENCE HILLS BEHIND MANIT,KOLAR NEHRU
NAGAR BYPASS ROAD , BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH |
6377717847
devjindersingh1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: PATIENTS, (2) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of either sex between the Age group of 21 – 60 years.
2. Patient having the sign and symptoms of Rheumatoid Arthritis (Amavata).
3. Patient who fulfilled the revised criteria for the diagnosis of Rheumatoid Arthritis (American Rheumatic Association 2010).
4. Patients willing to give written informed consent for the participation in the proposed Research work.
|
|
| ExclusionCriteria |
| Details |
1. Patient not fulfilling the inclusion criteria
2. Pregnant and lactating women
3. Patients having history of systemic complicated disease like, Tuberculosis, Diabetes HIV any malignancy etc.
4. Patients not willing for participation in research activity with written informed consent
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study on Rheumatoid arthritis (Amavata) will be helpful in finding the etiological factors involved in manifestation of Rheumatoid arthritis. |
The estimated time of study is upto october 2024 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is further expected that this study will be helpful in clinical practice for the prevention as well as management of Rheumatoid Arthritis (Amavata). |
12 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/10/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
CRITERIA FOR DIAGNOSIS
1.
Patient having signs and
symptoms of Rheumatoid Arthritis (Amavata)
2.
Revised Criteria for
the diagnosis of Rheumatoid Arthritis. (American Rheumatic Association 2010).
INVESTIGATIONS:
For Investigation purposes 3 ml Blood will be taken.
1.
ESR Rheumatoid Arthritis Factor Quantitative
C – Reactive Protein Quantitative CRITERIA FOR
SELECTION OF PATIENTS:
INCLUSION CRITERIA:
1.
Patient of either sex
between the Age group of 21 – 60 years.
2.
Patient having the
sign and symptoms of Rheumatoid
Arthritis (Amavata).
3.
Patient who fulfilled
the revised criteria for the diagnosis of Rheumatoid Arthritis (American
Rheumatic Association 2010).
4.
Patients willing to
give written informed consent for the participation in the proposed Research
work. EXCLUSION CRITERIA: 1. Patient
not fulfilling the inclusion criteria 2. Pregnant
and lactating women 3. Patients
having history of systemic complicated disease like, Tuberculosis, Diabetes HIV
any malignancy etc.
4. Patients
not willing for participation in research activity with written informed
consent |