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OpenTrials
Completed

NCT Number: NCT05795816

Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms

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.

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Key information

Conditions

Long Covid19 COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testofen

Drug

Twice daily dose of 1 capsule (300mg per capsule Testofen)

Microcrystalline Cellulose

Drug

Twice daily dose of 1 capsule

Primary outcomes

  1. Change in Energy and Fatigue

    Time frame: 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

  2. Change in Energy and Fatigue

    Time frame: 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 outcomes

  1. Change in Memory

    Time frame: Baseline, week 4, week 8 and week 12

    Change in Memory as measured by Short Term Memory testing

  2. Change in Mental Acuity

    Time frame: Baseline, week 4, week 8 and week 12

    Change in Mental acuity as measured by Reaction Time Test

  3. Change in Muscle Strength (Hand grip)

    Time frame: Baseline, week 4, week 8 and week 12

    Change in Muscle Strength (Hand grip) as measured by Dynamometer

  4. Change in Hair loss/growth

    Time frame: Baseline, week 4, week 8 and week 12

    Change in Hair loss/growth as measured by Hair loss questionnaire

  5. Change in Libido

    Time frame: 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)

  6. Change in Stress and Mood

    Time frame: Baseline, week 4, week 8 and week 12

    Change in Stress and Mood via Depression Anxiety and Stress Scale (DASS-21)

  7. Change in Quality of Life Indicators

    Time frame: Baseline, week 4, week 8 and week 12

    Change in Quality of Life Indicators via Symptom Burden Questionnaire - Long Covid

  8. Change in Pathology results via Blood test

    Time frame: 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

  9. Change in Weight

    Time frame: Baseline, week 4, week 8 and week 12

    Change in Weight as measured by scales in kg

  10. Height

    Time frame: Baseline, week 4, week 8 and week 12

    Height as measured by tape measure in centimetres

  11. Change in Safety as assessed by Adverse Events Recording

    Time frame: During enrolment period

    Change in Safety as assessed by Adverse Events Recording

  12. Change in safety markers as assessed by pathology

    Time frame: Baseline, week 4, week 8 and week 12

    Change in safety markers E/LFT as assessed by pathology

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2023
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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