Health Condition 1: M05-M14- Inflammatory polyarthropathies
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
DrDYPatil University
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed patients who are not on any treatment Diagnosis of rheumatoid arthritis as per 2010 American College of Rheumatology ACR or EULAR criteria with duration of not more than one year. Active disease defined as DAS28 CRP more than 3.2. Able and willing to give informed consent.
Exclusion criteria
Exclusion criteria: Major comorbidities (severe hepatic renal impairment) pregnancy or breastfeeding. Prior or current biologic therapy within last 6 months. Uncontrolled infection or immunosuppression. Known allergy to study Ayurvedic formulations or components. Inability to attend follow-ups.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess change in DAS28 score and proportion achieving low disease activity or remission (DAS28 criteria) with CRP levelTimepoint: Assess change in DAS28 score and proportion achieving low disease activity or remission (DAS28 criteria) with CRP level at baseline 3months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess changes in antiCCP RF titers & ESR from baseline to 3 months & 6 months Assess change in functional status (Health Assessment Questionnaire HAQ). Assess safety & adverse events in both arms. Explore patient-reported outcomes: pain (VAS). Economic outcomes: Direct medical costs (consultations, drugs, hospital visits). Indirect costs (workdays lost, caregiver time) Timepoint: 3 months & 6 months | — |
Countries
India
Contacts
Public ContactKajal Srivastava
Dr.D.Y.Patil Medical College, hospital and Reseach centre Pimpri Pune
Outcome results
None listed