Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Tirderness Score: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosis of another systemic disease during the study period
- •Pregnancy
- •Allergy to any component of EVACUR
- •Withdrawal of consent
研究组 & 干预措施
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
干预措施: EVACUR (Dietary Supplement)
PLACEBO
consists of starch capsules arranged in a bottle that looks identical to that of EVACUR.
干预措施: PLACEBO (Other)
结局指标
主要结局
Tirderness Score: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
时间窗: 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
次要结局
未报告次要终点
研究者
Tayssir Ben Achour
principal investigator
University Tunis El Manar