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Search / Trial NCT04033809

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

Rheumatoid Arthritis Fiber Multigrain

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.

Locations

Kubang Kerian, Kelantan, Malaysia

Patients applied

0 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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