Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms
- Registration Number
- NCT05795816
- Lead Sponsor
- RDC Clinical Pty Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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Adults 18 years and over
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Able to provide informed consent
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Diagnosed with COVID-19 infection (RAT or PCR test) >4 weeks, but < 12 months and experiencing post COVID symptoms (1)
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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
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Symptoms resulting from vaccination (2)
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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)
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Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
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Receiving/prescribed coumandin (Warfarin), heparin, dalteaparin, enoxaparin or other anticoagulation therapy
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Receiving pharmaceutical treatment for anxiety, libido, low energy
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Active smokers, nicotine use, alcohol, or drug (prescription or illegal substances) abuse
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Chronic past and/or current alcohol use (>14 alcoholic drinks per week)
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Allergic to any of the ingredients in the active or placebo formula
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Known pregnant or lactating women
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Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
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Participants who have participated in any other related clinical study during the past 1 month
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Microcrystalline cellulose Microcrystalline cellulose Microcrystalline cellulose in capsule form - taken as per Active comparator Testofen Testofen Testofen in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening)
- Primary Outcome Measures
Name Time Method Change in Energy and Fatigue 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
- Secondary Outcome Measures
Name Time Method Change in Memory Baseline, week 4, week 8 and week 12 Change in Memory as measured by Short Term Memory testing
Change in Mental Acuity Baseline, week 4, week 8 and week 12 Change in Mental acuity as measured by Reaction Time Test
Change in Muscle Strength (Hand grip) Baseline, week 4, week 8 and week 12 Change in Muscle Strength (Hand grip) as measured by Dynamometer
Change in Hair loss/growth Baseline, week 4, week 8 and week 12 Change in Hair loss/growth as measured by Hair loss questionnaire
Change in Libido Baseline, week 4, week 8 and week 12 Change in Libido as measured by - If male, DISF-SR (Derogatis Sexual Function Index), If female, FSFI (Female Sexual Function Index)
Change in Stress and Mood Baseline, week 4, week 8 and week 12 Change in Stress and Mood via Depression Anxiety and Stress Scale (DASS-21)
Change in Quality of Life Indicators Baseline, week 4, week 8 and week 12 Change in Quality of Life Indicators via Symptom Burden Questionnaire - Long Covid
Change in Pathology results via Blood test Baseline, week 4, week 8 and week 12 Change in Pathology results (Full blood count, CRP, iron, Soluble P-selectin, Testosterone, DHT, SHBG, Estrogen, IGF1, Cortisol, Prostaglandins, Inflammatory markers IL-10, IL-6, IL-17, TNF-a) as measured by Blood test
Change in Weight Baseline, week 4, week 8 and week 12 Change in Weight as measured by scales in kg
Height Baseline, week 4, week 8 and week 12 Height as measured by tape measure in centimetres
Change in Safety as assessed by Adverse Events Recording During enrolment period Change in Safety as assessed by Adverse Events Recording
Change in safety markers as assessed by pathology Baseline, week 4, week 8 and week 12 Change in safety markers E/LFT as assessed by pathology
Trial Locations
- Locations (1)
RDC Clinical Pty Ltd
🇦🇺Brisbane, Queensland, Australia