| CTRI Number |
CTRI/2024/10/074910 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Ama evaluation in Rheumatoid arthritis(Amavata)with reference to RA-Factor and CRP. |
|
Scientific Title of Study
|
ANALYTICAL STUDY OF AMA IN RELATION TO RHEUMATOID FACTOR AND CRP IN 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 Ruby Rani Agarwal |
| Designation |
Professor |
| Affiliation |
Rihikul Ayurvedic College,Haridwar |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan
OPD NO-21
Rishikul Campus Haridwar
Pincode-249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9456100745 |
| Fax |
|
| Email |
ruby6758@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruby Rani Agarwal |
| Designation |
Professor |
| Affiliation |
Rihikul Ayurvedic College,Haridwar |
| Address |
Department Of Rog Nidan Evum Vikriti Vigyan
OPD NO-21
Rishikul Campus,Haridwar,Uttarakhand
UTTARANCHAL
249401
India |
| Phone |
9456100745 |
| Fax |
|
| Email |
ruby6758@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruby Rani Agarwal |
| Designation |
Professor |
| Affiliation |
Rihikul Ayurvedic College,Haridwar |
| Address |
Department Of Rog Nidan Evum Vikriti Vigyan
OPD NO-21
Rishikul Campus,Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
09456100745 |
| Fax |
|
| Email |
ruby6758@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus,Uttarakhand Ayurved University,Haridwar Pincode-249401 |
|
|
Primary Sponsor
|
| Name |
Rishikul CampusUAU |
| Address |
Department of Rog nidan Evum Vikriti Vigyan
Rishikul Campus, UAU,Haridwar
Pincode-249401 |
| 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 Suruchi Baluni |
Rishikul Ayurvedic College |
OPD And IPD NO.21,Rog Nidan Evum Vikriti Vigyan department,Rishikul Campus,UAU,Haridwar
Hardwar
UTTARANCHAL |
8057970323
baluniruchi11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,Uttarakhand Ayurved University,Rishikul Campus,Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling ACR/EULAR criteria 2020.
|
|
| ExclusionCriteria |
| Details |
1-Pregnant women and lactating mother.
2-Individual having cardiovascular disease, abnormal thyroid hormone, renal disease , HIV, Viral hepatitis, carcinoma, SLE, Leprosy and other auto-immune diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Ama in rheumatoid arthritis(Amavata)with the level of CRP. |
01 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Ama in rheumatoid arthritis(Amavata)with the level RA Factor. |
01 month |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
15/10/2024 |
| 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="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
|
The study will be done to assess the level of Ama in patient of rheumatoid arthritis(Amavata) fulffing ACR-EULAR Criteria. After that an observational study will be done to asses the relation of ama with respect to the level of RA-Factor and CRP.The level of these markers and the result of the study will be helpful in reducing the progression and for affective management of the patients suffering from Rheumatoid Arthritis(Amavata). |