Clinical trial NCT05795816: Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms
Official title: The Effectiveness of Testofen on Energy, Fatigue, Mental Acuity, and Other Quality of Life Symptoms Post COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Long Covid19
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

  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.

Primary outcomes:
measure: Change in Energy and Fatigue
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change in Energy and Fatigue
timeFrame: Baseline, week 4, week 8 and week 12
Secondary outcomes:
measure: Change in Memory
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change in Mental Acuity
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change in Muscle Strength (Hand grip)
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change in Hair loss/growth
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change in Libido
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change in Stress and Mood
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change in Quality of Life Indicators
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change in Pathology results via Blood test
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change in Weight
timeFrame: Baseline, week 4, week 8 and week 12
measure: Height
timeFrame: Baseline, week 4, week 8 and week 12
measure: Change in Safety as assessed by Adverse Events Recording
timeFrame: During enrolment period
measure: Change in safety markers as assessed by pathology
timeFrame: Baseline, week 4, week 8 and week 12
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical Pty Ltd
state: Queensland
Study officials:
affiliation: RDC Clinical Pty Ltd
name: Amanda Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References: