Health Condition 1: M058- Other rheumatoid arthritis with rheumatoid factor
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 to 60 years of either sex Confirmed and diagnosed cases of Rheumatoid Arthritis based on established criteria e g American College of Rheumatology/European League Against Rheumatism criteria Active disease status as indicated by a Disease Activity Score DAS28 of more than or equal to 3 point 2 Chronic cases up to 5 years
Exclusion criteria
Exclusion criteria: Pregnant or lactating individuals due to potential risks associated with the treatments Known contraindications or allergy to any of the study drugs contents or Mritika Lepa Presence of significant comorbidities such as uncontrolled diabetes hypertension renal or hepatic impairment which may interfere with the assessment of study outcomes Coexistence of other autoimmune diseases e g systemic lupus erythematosus that may confound the assessment of Rheumatoid Arthritis outcomes Severe joint damage or deformities that may limit accurate pain assessment or interfere with the treatment outcomes Use of systemic immunosuppressive agents within the last three months prior to enrolment Recent major surgery within the last three months that may impact the study outcomes Participation in another clinical trial within 30 days before screening Inability to comply with the study procedures or follow-up visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity measured using a standardized pain scaleTimepoint: Change in pain intensity measured using a standardized pain scale in two weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Changes in inflammatory biomarker levels like C reactive protein erythrocyte sedimentation rate and complete blood count 2 Improvement in functional status using disease specific assessment tools DAS 28 Score for Rheumatoid Arthritis 3 Incidence of adverse events and side effects associated with the use of Oral Ayurveda drugs and Mritika Lepa and their combination in patients with Rheumatoid Arthritis Timepoint: 2 weeks | — |
Countries
India
Contacts
National Institute of Ayurveda