| CTRI Number |
CTRI/2024/05/066662 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Analytical |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of inflammatory markers in diagnosed patients of Rheumatoid Arthritis. |
|
Scientific Title of Study
|
A critical analysis of basic inflammatory markers in diagnosed cases of 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 |
Vaishnavi Behera |
| Designation |
UG SCHOLAR -IV YEAR BAMS |
| Affiliation |
KLE B.M KANKANAWADI AYURVEDA MAHAVIDYALAYA |
| Address |
B.M KANKANAWADI AYURVEDA MAHAVIDYALAYA,Shahpur,Belgavi
B.M KANKANAWADI AYURVEDA MAHAVIDYALAYA, Shahpur,Belgavi
Belgaum
KARNATAKA
590003
India |
| Phone |
8180037857 |
| Fax |
|
| Email |
vaishnavi.behera2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr .Manjula Kivadasannavar |
| Designation |
HOD & Prof. Dept Of Roga Nidan evum Vikriti Vigyan |
| Affiliation |
KLE B.M KANKANAWADI AYURVEDA MAHAVIDYALAYA |
| Address |
B.M KANKANAWADI AYURVEDA MAHAVIDYALAYA,Shahpur,Belgavi
OPD no.7,Dept of Roga Nidan Evum Vikriti Vigyan, B.M KANKANAWADI AYURVEDA MAHAVIDYALAYA,Shahpur,Belgavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844946360 |
| Fax |
|
| Email |
manjulak.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi Behera |
| Designation |
UG SCHOLAR- IV year BAMS |
| Affiliation |
KLE B.M KANKANAWADI AYURVEDA MAHAVIDYALAYA |
| Address |
B.M KANKANAWADI AYURVEDA MAHAVIDYALAYA,Shahpur,Belgavi
opd 7, dept. of roga nidan and vikriti vigyan, B.M KANKANAWADI AYURVEDA MAHAVIDYALAYA,Shahpur,Belgavi
Belgaum
KARNATAKA
590003
India |
| Phone |
8180037857 |
| Fax |
|
| Email |
vaishnavi.behera2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, shahpur, belgaum, karnataka-590003 |
|
|
Primary Sponsor
|
| Name |
KAHER RESEARCH GRANT |
| Address |
JNMC,KLE University Campus, Nehru Nagar, Belagavi, Karnataka 590010 |
| 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 |
| DrManjula Kivadasannavar |
KLE Shri B.M KANKANAWADI AYURVEDA MAHAVIDYALAYA |
O.P.D No. 07, Dept Of Roga Nidan Evum Vikriti Tantra, Shri B.M KANKANAWADI AYURVEDA,Shahpur,Belgavi MAHAVIDYALAYA,Shahpur
Belgaum
KARNATAKA |
9844946360
manjulak.kaher@kleayurworld.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee for research on human subjects KAHER;s Shri BMK Ayurved Mahavidyalaya, Shahpur, Belgaum, Karnataka-590003 |
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: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रकà¥à¤¤à¤®à¥‹à¤•à¥à¤·à¤£à¤®à¥/ शोणितसà¥à¤°à¤¾à¤µà¤ƒ/ असà¥à¤°à¤µà¤¿à¤¸à¥à¤°à¥à¤¤à¤¿à¤ƒ/शसà¥à¤¤à¥à¤°à | (Procedure Reference: Not applicable, Procedure details: Blood Investigation by Phlebotomy)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed Cases of amavata without other mentioned systemic disorders included in exclusion criteria.
|
|
| ExclusionCriteria |
| Details |
Aamvata patients with other systemic disorders like HIV, TB, Cancer. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Raised Inflamatory markers in patients of aamvata |
Day 1- Blood Investigation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/05/2024 |
| 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="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
|
It is a clinico-observational study on the patients of amavata to establish the co-relation between inflammatory markers and amavata, in which ESR, CRP and RA TITER would be performed on the enrolled subjects. The study is done to establish co-relation between severity of amavata and quantitative value of inflammatory markers. |