NCT07398885Completed
Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 13 Mar 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Apr 2025
- Lead sponsor
- University Tunis El Manar
- Diseases
- Lupus (SLE)
- NCT number
- NCT07398885
What you commit to
- Study type: Interventional
- Participants enrolled: 59
- From 1 Jul 2024 to the primary completion date, 1 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of another systemic disease during the study period
- Allergy to any component of EVACUR
Other
- Pregnancy
- Withdrawal of consent
Who the study is looking for
- Age \> 18 years
- Confirmed diagnosis of SLE according to the 2019 ACR/EULAR classification criteria
- Presence of fatigue, defined as a FACIT-F score \< 34
- Signed informed consent
- Non-Inclusion Criteria:
- Pregnancy or breastfeeding
- Diseases or comorbidities that may influence fatigue:untreated hypothyroidism, psychosis common infections, and other autoimmune and inflammatory diseases
- Patients on vitamin K antagonist therapy, due to a possible interaction with Ginger and Nigella
- History of severe allergy or intolerance to EVACUR or any component of the placebo
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| La Rabta Hospital Coordinator of this site? Confirm its status | Ben Arous | Tunisia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.