Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients
Launched by UNIVERSITI SAINS MALAYSIA · Jul 25, 2019
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
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 a consequence of the potential side effects, many RA patients turn to other alternative remedies such as specialised diets and/or dietary supplements in a bid to relieve their symptoms. Therefore, the current study aims to examine the effectiveness of high fiber multigrain supplementation on the level of clinical disease severity measures, blood inflammatory molecules, together with the nutriti...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Universiti Sains Malaysia
Universiti Sains Malaysia (USM) is a leading research university in Malaysia, renowned for its commitment to advancing scientific knowledge and innovation in the healthcare sector. As a clinical trial sponsor, USM leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous research aimed at improving patient outcomes and addressing pressing health challenges. The university fosters collaboration among researchers, medical professionals, and industry partners, ensuring that its clinical trials are conducted with the highest ethical standards and scientific integrity. Through its dedication to excellence in research and education, USM plays a pivotal role in shaping the future of healthcare both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kubang Kerian, Kelantan, Malaysia
Patients applied
Trial Officials
Lai Kuan Lee, PhD
Principal Investigator
Universiti Sains Malaysia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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