NCT05795816已完成3 期
The Effectiveness of Testofen on Energy, Fatigue, Mental Acuity, and Other Quality of Life Symptoms Post COVID-19 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Energy and Fatigue
研究概览
简要总结
This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Testofen (a specialised extract of Trigonella foenum-graecum (Fenugreek) seed) compared to placebo on post COVID-19 symptoms in otherwise healthy participants 18 years and over.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years and over
- •Able to provide informed consent
- •Diagnosed with COVID-19 infection (RAT or PCR test) >4 weeks, but < 12 months and experiencing post COVID symptoms (1)
- •Agree not to participate in another clinical trial while enrolled in this trial
- •Common post COVID symptoms may include fatigue, cough, chest pain, hair loss, weakness, joint pain, cardiac issues, neurocognitive impairment including memory loss, and decreased quality of life
排除标准
- •Symptoms resulting from vaccination (2)
- •Unstable or serious illness (e.g., serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction) (3)
- •Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
- •Receiving/prescribed coumandin (Warfarin), heparin, dalteaparin, enoxaparin or other anticoagulation therapy
- •Receiving pharmaceutical treatment for anxiety, libido, low energy
- •Active smokers, nicotine use, alcohol, or drug (prescription or illegal substances) abuse
- •Chronic past and/or current alcohol use (>14 alcoholic drinks per week)
- •Allergic to any of the ingredients in the active or placebo formula
- •Known pregnant or lactating women
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participants who have participated in any other related clinical study during the past 1 month
- •History of infection in the month prior to the study
- •(2) Symptoms must be as a direct result of having contracted COVID. If symptoms only appeared within 2 weeks of a vaccination it will be considered a vaccine injury and not classed as a result of COVID.
- •(3) An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
研究组 & 干预措施
Testofen
Active Comparator
Testofen in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening)
干预措施: Testofen (Drug)
Microcrystalline cellulose
Placebo Comparator
Microcrystalline cellulose in capsule form - taken as per Active comparator
干预措施: Microcrystalline cellulose (Drug)
结局指标
主要结局
Change in Energy and Fatigue
时间窗: Baseline, week 4, week 8 and week 12
Change in energy and fatigue as measured via Global Fatigue Index. The items are scored on a 10 point scale with 1 = not at all and 10 = great deal. Higher he score = greater fatigue
次要结局
- Change in Memory(Baseline, week 4, week 8 and week 12)
- Change in Mental Acuity(Baseline, week 4, week 8 and week 12)
- Change in Muscle Strength (Hand grip)(Baseline, week 4, week 8 and week 12)
- Change in Hair loss/growth(Baseline, week 4, week 8 and week 12)
- Change in Libido(Baseline, week 4, week 8 and week 12)
- Change in Stress and Mood(Baseline, week 4, week 8 and week 12)
- Change in Quality of Life Indicators(Baseline, week 4, week 8 and week 12)
- Change in Pathology results via Blood test(Baseline, week 4, week 8 and week 12)
- Change in Weight(Baseline, week 4, week 8 and week 12)
- Height(Baseline, week 4, week 8 and week 12)
- Change in Safety as assessed by Adverse Events Recording(During enrolment period)
- Change in safety markers as assessed by pathology(Baseline, week 4, week 8 and week 12)
研究者
研究点 (1)
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