Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Testofen Testofen in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening) |
Drug: Testofen
Twice daily dose of 1 capsule (300mg per capsule Testofen)
|
| Placebo Comparator: Microcrystalline cellulose Microcrystalline cellulose in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening) |
Drug: Microcrystalline cellulose
Twice daily dose of 1 capsule (300mg per capsule)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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 (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
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | RDC Clinical Pty Ltd | Brisbane | Queensland | Australia | 4006 |
Sponsors and Collaborators
- RDC Clinical Pty Ltd
Investigators
- Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FENCOV