| CTRI Number |
CTRI/2024/05/067785 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To identify the particular reason in occurence of Rheumatoid Arthritis disease. |
|
Scientific Title of Study
|
A Retrospective Observational Study to Evaluate the relation between Amavata nidanas and lakshana with special refernce to Rheumatoid Arthritis |
| 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 Suma Jambli |
| Designation |
Associate Professor |
| Affiliation |
Sanjeevini Ayurvedic Medical College and Hospital, Hubballi |
| Address |
Sanjeevini Ayurveda Medical College and Hospital Second Floor Room No 16 Block 1
Basaveshwara Nagar
Gokul Road
Hubballi
Dharwad
KARNATAKA
580030
India |
| Phone |
9902458776 |
| Fax |
|
| Email |
suma.jambli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suma Jambli |
| Designation |
Associate Professor |
| Affiliation |
Sanjeevini Ayurvedic Medical College and Hospital, Hubballi |
| Address |
Sanjeevini Ayurveda Medical College and Hospital Second Floor Room No 16 Block 1
Basaveshwara Nagar
Gokul Road
Hubballi
KARNATAKA
580030
India |
| Phone |
9902458776 |
| Fax |
|
| Email |
suma.jambli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suma Jambli |
| Designation |
Associate Professor |
| Affiliation |
Sanjeevini Ayurvedic Medical College and Hospital, Hubballi |
| Address |
Sanjeevini Ayurveda Medical College and Hospital Second Floor Room No 16 Block 1
Basaveshwara Nagar
Gokul Road
Hubballi
KARNATAKA
580030
India |
| Phone |
9902458776 |
| Fax |
|
| Email |
suma.jambli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjeevini Ayurveda Medical College and Hospital
Second floor Room No 16 Block 1 Basaveshwara nagar Gokul Road Hubballi 580030 |
|
|
Primary Sponsor
|
| Name |
Sanjeevini Ayurveda Medical College and Hospital |
| Address |
Second Floor Room No 14 Block 1
Basaveshwara Nagar
Gokul Road
Hubballi 580030 |
| Type of Sponsor |
Private 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 Suma Jambli |
Sanjeevini Ayurveda Medical College and Hospital |
Second Floor Room No 16 Block 1
Basaveshwara Nagar Gokul Road Hubballi 580030
Dharwad
KARNATAKA |
9902458776
suma.jambli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Sanjeevini Ayurveda Medical College and Hospital |
Approved |
| Sanjeevini Ayurveda Medical College and Hospital hubballi |
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 |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with clinical features and diagnosed as Amavata
Sero negative and Sero positive will be included
Subjects suffering with other chronic diseases along with Amavata will be included
Subjects of either sex with age group between 20 to 40 years will be selected
History of Amavata more than 6 weeks and less than 5 years
|
|
| ExclusionCriteria |
| Details |
Less than 6 weeks and more than 5 years of history are excluded
Patient aged less than 20 year and more than 40 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the specific nidanas in manifestation of amavata lakshanas |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify specific nidana which helps in preventing in the occurence of amavata. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/07/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 title name A Retroseptive observational Study to Evaluate the Relation between Amavata Nidanas and Lakshana with Special Reference to Rheumatoid Arthritis which aims to analyze the etiological factors in amavata manifestation and to co relate the specfic nidana with specific amavata lakshana by this observational study prevention of amavata can be done by avoiding the intake of nidanas the nidanas related to amavata will be enlisted and evalauted by building a special case sheet proforma sample size of 100 with diagnosed cases of RA will be taken for study who are approaching the OPD IPD of Sanjeevini Ayurveda Medical College and Hospital Hubballi |