Status:
COMPLETED
Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients
Lead Sponsor:
Universiti Sains Malaysia
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the effect of high fiber multigrain supplementation on the level of clinical disease severity measures, blood inflammatory molecules, and nutritional status ...
Detailed Description
Rheumatoid Arthritis (RA) is a chronic inflammatory, autoimmune rheumatic disease, resulting in progressive joint inflammation and destruction. At present, there is no known cure for this disease. As ...
Eligibility Criteria
Inclusion
- RA patients according to the American College of Rheumatology (ACR)
- Moderate (DAS 28 = 3.2 - 5.1) and severe (DAS 28 \> 5.1) RA manifestation
- Chronological age: 21 years and above
- Stable RA patients who are receiving NSAIDs, glucocorticoids/DMARDs (for example leflunomide, methotrexate, sulfasalazine and hydroxychloroquine) for at least 3 months prior to entering the study
- Not taking antioxidant/antiinflammatory supplements (Example of antioxidant: vitamin C, vitamin E, grape seed extract, garlic capsule, ginkgo biloba) (Example of anti-inflammatory supplement: fish oil, curcumin extract, ginger extract, spirulina)
Exclusion
- Having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders
- Active gastric/duodenal ulcer
- Psychiatric disease/mental retardation (bipolar disorder, depression, schizophrenia)
- Cancer (all types), Diabetes Mellitus (Type I and II), uncontrolled hypertension (BP at 140/90 mmHg for the past 3 months), and endocrine disorders (Cushing's disease, gigantism and hyperthyroidism).
- Alcohol and drug abuse (self-mentioned or as recorded in the medical card)
- Other autoimmune/inflammatory diseases (systemic lupus erythematosus, multiple sclerosis, gout, psoriasis, chronic inflammatory demyelinating polyneuropathy)
- Pregnancy/lactation
- Hormone replacement therapy (for at least 3 months prior to entering the study)
- Herbal remedies (any parts from the plants such as flowers, rhizome, seeds, roots, leaves, fruits, stems)
- Vegetarian patient (pure vegan)
- Gluten intolerance
- Participations from another supplementary program
Key Trial Info
Start Date :
May 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04033809
Start Date
May 30 2019
End Date
December 31 2019
Last Update
May 10 2023
Active Locations (1)
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1
Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150