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

NCT07398885 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • System; Lupus Erythematosus

Interventions

DIETARY_SUPPLEMENT

EVACUR

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

OTHER

PLACEBO

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.

Sponsors & Collaborators

  • University Tunis El Manar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-04-01
Completion
2025-05-07

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398885 on ClinicalTrials.gov