Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of Testofen on Energy, Fatigue, Mental Acuity, and Other Quality of Life Symptoms Post COVID-19 Infection

Conditions
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Long Covid19

Intervention / Treatment
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* Drug: Testofen
* Drug: Microcrystalline cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testofen<br>Testofen in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening) | Drug: Testofen<br>* Twice daily dose of 1 capsule (300mg per capsule Testofen)<br>|
| Placebo Comparator: Microcrystalline cellulose<br>Microcrystalline cellulose in capsule form - taken as per Active comparator | Drug: Microcrystalline cellulose<br>* Twice daily dose of 1 capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Energy and Fatigue | Change in energy and fatigue as measured via Fatigue Severity Scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity | Baseline, week 4, week 8 and week 12 | 
| Change in Energy and Fatigue | 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 | Baseline, week 4, week 8 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Memory | Change in Memory as measured by Short Term Memory testing | Baseline, week 4, week 8 and week 12 | 
| Change in Mental Acuity | Change in Mental acuity as measured by Reaction Time Test | Baseline, week 4, week 8 and week 12 | 
| Change in Muscle Strength (Hand grip) | Change in Muscle Strength (Hand grip) as measured by Dynamometer | Baseline, week 4, week 8 and week 12 | 
| Change in Hair loss/growth | Change in Hair loss/growth as measured by Hair loss questionnaire | Baseline, week 4, week 8 and week 12 | 
| Change in Libido | Change in Libido as measured by - If male, DISF-SR (Derogatis Sexual Function Index), If female, FSFI (Female Sexual Function Index) | Baseline, week 4, week 8 and week 12 | 
| Change in Stress and Mood | Change in Stress and Mood via Depression Anxiety and Stress Scale (DASS-21) | Baseline, week 4, week 8 and week 12 | 
| Change in Quality of Life Indicators | Change in Quality of Life Indicators via Symptom Burden Questionnaire - Long Covid | Baseline, week 4, week 8 and week 12 | 
| Change in Pathology results via Blood test | Change in Pathology results (Full blood count (including platelet aggregation), 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 | Baseline, week 4, week 8 and week 12 | 
| Change in Weight | Change in Weight as measured by scales in kg | Baseline, week 4, week 8 and week 12 | 
| Height | Height as measured by tape measure in centimetres | Baseline, week 4, week 8 and week 12 | 
| Change in Safety as assessed by Adverse Events Recording | Change in Safety as assessed by Adverse Events Recording | During enrolment period | 
| Change in safety markers as assessed by pathology | Change in safety markers E/LFT as assessed by pathology | Baseline, week 4, week 8 and week 12 |