At a glance
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Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial
In Brief
A clinical study evaluating EVACUR and PLACEBO for System; Lupus Erythematosus. Completed, enrolled 59 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
It is a herbal therapy in capsule form. It is a bottle containing 40 capsules composed of: black seed, zinc sulfate, Echinacea, vitamin C, red ginseng, ginger, chamomile, spirulina, royal jelly, Ganoderma, vitamin B1, B6, B12, selenium. EVACUR is adminstrated at a rate of 2 capsules per day in the morning
starch capsules arranged in a bottle that looks identical to that of EVACUR. It is administered at a rate of 2 capsules per day in the morning.