Long Covid19
Conditions
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.
Interventions
DRUGTestofen
Twice daily dose of 1 capsule (300mg per capsule Testofen)
DRUGMicrocrystalline cellulose
Twice daily dose of 1 capsule
Sponsors
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 1. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Energy and Fatigue | Baseline, week 4, week 8 and week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Memory | Baseline, week 4, week 8 and week 12 | Change in Memory as measured by Short Term Memory testing |
| 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 |
| 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 |
Countries
Australia
Outcome results
None listed