Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
None listed
Sponsors
Central Council for Research In Ayurvedic Sciences CCRAS Ministry Of Ayush, Government Of India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants of age between 18 and 65 years, diagnosed with Rheumatoid arthritis (as per ACR 2010 criteria) 2.Participants willing to give written informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1.Participants presenting with complications of Rheumatoid Arthritis e.g. deformity of joints / bones, pleura-pericardial disease, or else 2.Participants with extra articular manifestations of RA and gastrointestinal symptoms 3.Participants with joint prosthesis and those who are unable to walk without support and / or confined to wheel chair 4.Participants with Hemoglobin 5.Participants diagnosed with other arthritis like osteoarthritis, gouty arthritis, tuberculous arthritis, Psoriatic arthritis, spondyloarthropathy, active fibromyalgia, juvenile chronic arthritis, ulcerative colitis, or other systemic inflammatory conditions and auto-immune diseases. 6.Participants having blood pressure >=160/100 mmHg, &/or HbA1C >8 % 7.Participants on medication with corticosteroids, antidepressants, anticholinergics, etc. Or Ayush interventions/folk medicine, or any other drugs that may have an influence on the outcome of the study 8.Participants with diagnosed concurrent neurological, pulmonary or endocrine disorder, or unstable cardio-vascular disease 9.Participants with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine > upper normal limit) 10.Participants with alcohol use disorder (AUD) (CAGE score >2) or any other substance abuse (Annexure II) 11.Pregnant / lactating woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Change in DAS-28 score with ESR Timepoint: â?¢Time Frame: Baseline & 84th day | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Change in disease specific biochemical & inflammatory markers (RA factor, CRP, ESR) â?¢Change in Participants Assessment of Pain [assessed through Visual analog scale (VAS) ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain) â?¢Change in Participants Global Assessment of Disease Activity assessed through Visual analog scale. â?¢Change in Disability Index score (The Indian Health Assessment Questionnaire) â?¢Change in Serum Immunoglobulin (Ig) Levels of IgG, IgM. â?¢Frequency of use of conventional analgesic/NSAIDs medicines. â?¢Assessment of any adverse events Timepoint: Time Frame: Baseline & 84thday Time Frame: Baseline, 28th day, 56th Day & 84thday Time Frame: Baseline, 28th day, 56th Day and 84thday Time Frame: Baseline, 28th day, 56th Day and 84th day Time Frame: Baseline and 84th day Time Frame: Baseline, 28th day, 56th Day and 84th day Time Frame: From baseline upto 84th day | — |
Countries
India
Contacts
Public ContactDr Sunita
Central Council for Research in Ayurvedic Sciences
Outcome results
None listed