Feasibility Study: Curcumin; A clinical trial for gout in Samoa

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: 500mg curcumin capsule administered orally once per day for 3 months. Adherence will be monitored during each visit using pill counts. CONDITION: Alternative and Complementary Medicine ‐ Herbal remedies Gout;Hyperuricaemia; ; Gout ; Hyperuricaemia Musculoskeletal ‐ Other muscular and skeletal disorders PRIMARY OUTCOME: Serum urate.; Serum urate was assessed using a peripheral venous blood sample.; [Baseline, and 1 (primary endpoint), 2, and 3 months post‐intervention commencement] SECONDARY OUTCOME: Acceptability of patients to donate their body samples. This outcome was assessed using the Feasibility issues questionnaire. This questionnaire was designed specifically for this study.[Patients' acceptability to donate their body samples will be assessed prior to the commencement of the intervention (Baseline).] Acceptability of patients to participate. This outcome was assessed using the Feasibility issues questionnaire. This questionnaire was designed specifically for this study.[Acceptability of patients to participate will be assessed prior to the commencement of the intervention (Baseline).] Gout flares. The number of gout flares in month 1, month 2, and month 3 was assessed using the Gout Flare and Pain Questionnaires/Dairy/LOG (Janssen et al.,20119). ; ; ; [Baseline, and 1, 2, and 3 months post‐intervention commencement] Pain severity. Pain severity in month 1, month 2, and month 3 was assessed using the Gout Flare and Pain Questionnaires/Dairy/LOG (Janssen et al.,20119).[Baseline, and 1, 2, and 3 months post‐intervention commencement] Patient global assessment. Patient global assessment in month 1, month 2, and month 3 was assessed using the Patient Global Assessment Questionnaire (Singh et al., 2011).[Baseline, and 1, 2, and 3 months post‐intervention commencement] Recruitment process. The recruitment process will be assessed by the number of eligible participants enrolled, This outcome was assessed using an audit of the study database.[Upon completion of the recruitment process] The number of attacks. The number of attacks in month 1, month 2, and month 3 was assessed using the Gout Flare and Pain Questionnaires/Dairy/LOG (Janssen et al.,20119).[Baseline, and 1, 2, and 3 months post‐intervention commencement] INCLUSION CRITERIA: • Existing serum urate of greater than or equal to 0.36 mmol/L • At least 1 gout flare in the last 6 months • Capable of providing informed consent and having provided it • Aged between 17 and 80 years • Gout, according to the 2015 ACR/EULAR classification criteria • Samoan ethnicity
Epistemonikos ID: 6b7592c0822f9ec1987e565284598b2cd8b42f90
First added on: Aug 25, 2024