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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Twice daily dose of 1 capsule (300mg per capsule Testofen)
Twice daily dose of 1 capsule
RDC Clinical Pty Ltd
Brisbane, Queensland, Australia
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
Time frame: 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
Time frame: Baseline, week 4, week 8 and week 12
Change in Memory
Change in Memory as measured by Short Term Memory testing
Time frame: Baseline, week 4, week 8 and week 12
Change in Mental Acuity
Change in Mental acuity as measured by Reaction Time Test
Time frame: Baseline, week 4, week 8 and week 12
Change in Muscle Strength (Hand grip)
Change in Muscle Strength (Hand grip) as measured by Dynamometer
Time frame: Baseline, week 4, week 8 and week 12
Change in Hair loss/growth
Change in Hair loss/growth as measured by Hair loss questionnaire
Time frame: 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)
Time frame: Baseline, week 4, week 8 and week 12
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Change in Stress and Mood
Change in Stress and Mood via Depression Anxiety and Stress Scale (DASS-21)
Time frame: 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
Time frame: Baseline, week 4, week 8 and week 12
Change in Pathology results via Blood test
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
Time frame: Baseline, week 4, week 8 and week 12
Change in Weight
Change in Weight as measured by scales in kg
Time frame: Baseline, week 4, week 8 and week 12
Height
Height as measured by tape measure in centimetres
Time frame: 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
Time frame: During enrolment period
Change in safety markers as assessed by pathology
Change in safety markers E/LFT as assessed by pathology
Time frame: Baseline, week 4, week 8 and week 12