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

NCT07398885 | Completed DMC

• 1 other identifier: UTelmanar
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Systemic Lupus Erythematosus , Fatigue, EVACUR, Herbal supplement, FACIT-F, SLEDAI, Randomized controlled trial.

Outcome Measures

Primary Outcomes (1)

• Tirderness Score: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  * This is a 13-question questionnaire to which the patient responds on a Likert scale ranging from 1 to 5 (1 = completely, 5 = not at all). By adding up the responses, a score out of 65 is obtained. The higher the score, the less fatigued the patient is \[2\]. * The score can be calculated once the patient has answered 50% of the questions. * Reliability: The Cronbach's alpha is good (0.94). * Validity: This tool has good validity as it has a strong correlation with the use of other scales. * It takes 5 to 10 minutes to complete the questionnaire and calculate the score. * The Arabic version (Appendix 3) has been validated with good psychometric properties

  at inclusion, after 1, 2 months

Study Arms (2)

EVACUR

EXPERIMENTAL

EVACUR and the placebo are produced by the Wellnet laboratory. 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. 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

Dietary Supplement: EVACUR

PLACEBO

PLACEBO COMPARATOR

consists of starch capsules arranged in a bottle that looks identical to that of EVACUR.

Other: PLACEBO

Interventions

EVACUR DIETARY_SUPPLEMENT

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

EVACUR

PLACEBO OTHER

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.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Diagnosis of another systemic disease during the study period
• Pregnancy
• Allergy to any component of EVACUR
• Withdrawal of consent

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

La Rabta Hospital

Ben Arous, 123, Tunisia

Location

Related Publications (4)

• Cella D, Yount S, Sorensen M, Chartash E, Sengupta N, Grober J. Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol. 2005 May;32(5):811-9.

  PMID: 15868614 BACKGROUND

• Al Maqbali M, Hughes C, Gracey J, Rankin J, Hacker E, Dunwoody L. Psychometric Properties of the Arabic Version of the Functional Assessment of Chronic Illnesses Therapy-Fatigue in Arabic Cancer Patients. J Pain Symptom Manage. 2020 Jan;59(1):130-138.e2. doi: 10.1016/j.jpainsymman.2019.10.008. Epub 2019 Oct 21.

  PMID: 31647976 BACKGROUND

• Dey M, Parodis I, Nikiphorou E. Fatigue in Systemic Lupus Erythematosus and Rheumatoid Arthritis: A Comparison of Mechanisms, Measures and Management. J Clin Med. 2021 Aug 13;10(16):3566. doi: 10.3390/jcm10163566.

  PMID: 34441861 RESULT

• Mertz P, Schlencker A, Schneider M, Gavand PE, Martin T, Arnaud L. Towards a practical management of fatigue in systemic lupus erythematosus. Lupus Sci Med. 2020 Nov;7(1):e000441. doi: 10.1136/lupus-2020-000441.

  PMID: 33214160 RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Fatigue

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Randomized double-blind clinical trial conducted at various internal medicine services in Tunisia over a period of 3 months.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: February 10, 2026
• Study Start: July 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 7, 2025
• Last Updated: February 10, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)