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

February 4, 2026 updated by: Tayssir Ben Achour, University Tunis El Manar

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 superior than 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. 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

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Ben Arous, Tunisia, 123
        • La Rabta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EVACUR

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

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
Placebo Comparator: PLACEBO
consists of starch capsules arranged in a bottle that looks identical to that of EVACUR.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tirderness Score: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time Frame: at inclusion, after 1, 2 months
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Tunis El Manar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

May 7, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTelmanar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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