Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial
Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial
NCT ID: NCT07398885 Phase: NA Status: COMPLETED Enrollment: 59 Completion: 2025-05-07
Conditions
System; Lupus Erythematosus
Interventions
EVACUR, PLACEBO
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.
Primary Outcome
Tirderness Score: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)