Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial
Phase: NA
Conditions: System; Lupus Erythematosus
Sponsor: University Tunis El Manar

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: 
Results from an 8-Week Randomized Trial 
 
20-01-2026 
 
 
 
 
 
 
 
 
 
 
 

Introduction  
Systemic lupus erythematosus (SLE) is a chronic auto-immune disease with a wide range of clinical 
manifestations and a complex pathogenesis. Despite advancements in treatments for disease activity, 
fatigue continues to be one of the most prominent and unresolved complaints among patients [1]. 
 According to Jianhua Shen et al. [2], fatigue is defined as an overwhelming sense of tiredness, a lack 
of energy, and a feeling of exhaustion that is associated with impaired physical and/or cognitive 
functioning. The prevalence of fatigue in SLE  may reach up to 90%, according to some studies[3]. 
Moreover, over 50% of patients report it as their most disabling symptom[3]. Stress, depression, pain, 
disease activity, and disease duration are among the most common contributors to fatigue in these 
patients. Fatigue significantly impacts quality of life (QoL) across all domains physical, psychological, 
and socio-occupational. Management recommendations for fatigue typically involve a combination of 
pharmacologic and nonpharmacologic approaches; however, no specific medications have been shown 
to be effective in treating fatigue associated with SLE[4].Hence, it is essential to evaluate and identify 
potential intervention areas to alleviate patients' symptom burden and enhance their overall quality of 
life. 
Therefore, we opted for the dietary supplement EVACUR.It is a dietary supplement designed to help 
combat fatigue and boost the immune system. It combines natural extracts, vitamins, and selenium to 
support overall vitality. 
The aim of our double-blind, placebo-controlled randomized trial was to evaluate the efficacy of using 
herbal-based treatment on patients with SLE-related fatigue . 
Methods: 
 Study Type: 
This was a randomized, double-blind clinical trial conducted in two internal medicine departments in 
Tunisia over a period of 3 months. 

Study Population: 
Patients with a diagnosis of SLE who were being followed in the participating departments. 
 Inclusion Criteria: 
 
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 
 Exclusion Criteria: 
 
Diagnosis of another systemic disease during the study period 
 
Pregnancy 
 
Allergy to any component of EVACUR 
 
Withdrawal of consent 
 
Data Collection: 
Patient data were collected from medical records,including epidemiological  characteristics such as age 
at inclusion , gender and medical and family history .Disease-specific data included the duration disease, 

systemic manifestations,nature of treatement at inclusion .Disease activity was evaluated using clinical 
SLEDAI-2K score. Baseline FACIT score was collected.Biological assessments were performed such 
us Anti-dsDNA antibody titers ,ANA and serum C3 and C4 levels. 
   Study protocol: 
Randomization: 
A two -to-one (2:1) randomization was performed in this study in which patients were randomly 
assigned into two groups: Group 1 (G1) which received EVACUR, and Group 2 (G2)  received a 
placebo. Randomization was handled by an independent third party using a dedicated randomization 
software. 
Double-Blind Design: 
Neither the patients nor the investigators knew the treatment assignment. EVACUR and placebo 
capsules are identical in appearance. 
Treatement: 
EVACUR: 
A phytotherapeutic compound presented in capsule form. Each bottle contains 40 capsules composed 
of: Nigella seed, Zinc sulfate, Echinacea, Vitamin C, Red ginseng, Ginger, Chamomile, Spirulina, Royal 
jelly, Ganoderma, Vitamins B1, B6, B12, Selenium(Table1). 
Contra-indications: Allergy to any component of the supplement. 
Placebo: 
Capsules containing starch, packaged identically to EVACUR bottles. 
Both treatments will be administered at a dose of 2 capsules per day in the morning (3 bottles per 
patient for the study duration). 

Follow-up: 
Patients attended three visits  at baselineM0, one monthM1, and two monthsM2. The FACIT score 
was assessed  during each visit along with a  physical examination. 
Adverse Events: 
Potential side effects will be recorded and evaluated throughout the study. Occurrence of any adverse 
event will lead to patient exclusion and trigger a pharmacovigilance investigation. All adverse events 
must be reported immediately to the principal investigator. 
 Fatigue Assessment Score: 
Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) 
A 13-item questionnaire with responses on a Likert scale from 1 (not at all) to 5 (very much). 
Total score out of 52; higher scores indicate less fatigue.Can be calculated if at least 50% of the 
questions are answered. 
Reliability: High (Cronbach’s alpha = 0.94) 
Validity: Strong, with good correlation with other fatigue measurement tools 
Completion time: 5–10 minutes 
A validated Arabic version is available with good psychometric properties . 
 Evaluation Criteria: 
Primary Endpoint: 
A mean Facit-F score improvement between G1 and G2 at month2 > Minimal Clinically Important 
Difference(MCID).The MCID  in SLE is estimated at 3.4T[5]. 

Secondary Endpoints: 
Improvement in the disease activity SLEDAI score  
Good tolerance of the dietary supplement. 
 Statistical Analysis: 
Data were analyzed using SPSS.Appropriate statistical tests will be applied, including Student’s t-test 
or the Wilcoxon test.Randomization will be conducted using dedicated software. 
 
Ethical considerations 
This study was conducted according to the Declaration of Helsinki and approved as well by the RABTA 
hospital’s ethics committee under the number of CERB33/2023. Informed consent was given by each 
patient before starting the study.Each patient will be assigned an inclusion number used for 
randomization and data entry, ensuring patient confidentiality. 
 
Statements & declarations:  
- Funding:  Wellnet Pharmaceutical Factory ® provided the dietary supplement and the placebo 
free of charge.No additional funding was required 
- Conflict of Interest:. Wellnet Pharmaceutical Factory® had no role in the study design, data 
collection, analysis, interpretation, or decision to submit the manuscript for publication. 
-Informed consent 
Informed consent was obtained from all individual participants included in the study after reading and 
agreeing with the details of this trial. 
- Availability of data and material :data are available on request from the authors  
- Ethics approval :Patients’ anonymity was maintained throughout the study. The study was approved 
by the ethics committee of the hospital under the number CERB 33/2023. 

Table 1. Ingredients and Dosage of EVACUR Formulation per Capsule 
 
Ingredient 
Latin/INCI Name 
Form/Quality 
Quantity per capsule 
Black seed 
Nigella sativa 
Dry extract 
80 mg 
Echinacea 
Echinacea spp. 
Dry extract 
40 mg 
Ginger 
Zingiber officinale 
Dry extract 
30 mg 
Chamomile 
Matricaria chamomilla Dry extract 
10 mg 
Red ginseng 
Panax ginseng 
Dry extract 
10 mg 
Reishi mushroom Ganoderma lucidum 
Dry extract 
10 mg 
Spirulina 
Spirulina spp. 
Dry extract 
60 mg 
Royal jelly 
Royal jelly 
Lyophilized 
20 mg 
Vitamin C 
Ascorbic acid 
— 
30 mg 
Zinc 
Zinc sulfate 
— 
2.5 mg 
Vitamin B1 
Thiamine 
— 
3 mg 
Vitamin B6 
Pyridoxine 
Marine source 4 mg 
Vitamin B12 
Cobalamin 
— 
10 µg 
Selenium 
Selenium yeast 
— 
40 µg