Clinical Trial

Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial

Study acronym: TIR-CUR
Completed
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Summary
Fatigue is one of the most prevalent and disabling manifestations of systemic lupus erythematosus. Although its management often entails a combination of pharmacologic and non-pharmacologic strategies, no pharmacologic intervention has yet demonstrated consistent efficacy. Aim: The purpose of this clinical study was to explore the efficacy of using herbal-based treatment on patients with SLE-related fatigue . Methods: We performed a 8-week,randomized, double-blinded, placebo-controlled clinical trial in two internal medicine departments in Tunisia over a period of 2 months. We included patients with SLE who met the classification criteria of the 2019-EULAR/ACR classification criteria for SLE and had a FACIT-F (Functional Assessment of Chronic Illness Therapy-fatigue) score minor than 34. After screening, patients were randomly assigned to the EVACUR treatment group or placebo group. The primary endpoints were changes in fatigue (FACIT-F) and disease activity (SLEDAI) scores.
Trial Details
NCT Number NCT07398885
Lead Sponsor University Tunis El Manar
Conditions System; Lupus Erythematosus
Enrollment 59 participants
Start Date 2024-07-01
Primary Completion 2025-04-01 (estimated)
Study Completion 2025-05-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-10