Long Covid19Phase 3NCT05795816
Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms
A Phase 3 study testing Testofen and Microcrystalline cellulose in people with Long Covid19, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Covid19
- What is being tested?
- Testofen and Microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Oct 2023to 31 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Testofen on Energy, Fatigue, Mental Acuity, and Other Quality of Life Symptoms Post COVID-19 Infection
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.
- Conditions
- Long Covid19
- Being tested
- Testofen, Microcrystalline cellulose
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestofenDrug
Twice daily dose of 1 capsule (300mg per capsule Testofen)
Microcrystalline celluloseDrug
Twice daily dose of 1 capsule
| Study group | Role | What they receive |
|---|---|---|
| Testofen | Active comparator | Testofen in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening) Receives: Drug: Testofen |
| Microcrystalline cellulose | Placebo comparator | Microcrystalline cellulose in capsule form - taken as per Active comparator Receives: Drug: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, week 4, week 8 and week 12
Secondary outcomes (12)
Change in Memory
Change in Memory as measured by Short Term Memory testing
Measured: Baseline, week 4, week 8 and week 12
Change in Mental Acuity
Change in Mental acuity as measured by Reaction Time Test
Measured: Baseline, week 4, week 8 and week 12
Change in Muscle Strength (Hand grip)
Change in Muscle Strength (Hand grip) as measured by Dynamometer
Measured: Baseline, week 4, week 8 and week 12
Change in Hair loss/growth
Change in Hair loss/growth as measured by Hair loss questionnaire
Measured: 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)
Measured: Baseline, week 4, week 8 and week 12
Change in Stress and Mood
Change in Stress and Mood via Depression Anxiety and Stress Scale (DASS-21)
Measured: 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
Measured: 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
Measured: Baseline, week 4, week 8 and week 12
Change in Weight
Change in Weight as measured by scales in kg
Measured: Baseline, week 4, week 8 and week 12
Height
Height as measured by tape measure in centimetres
Measured: 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
Measured: During enrolment period
Change in safety markers as assessed by pathology
Change in safety markers E/LFT as assessed by pathology
Measured: Baseline, week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start25 Oct 2023
- Primary completion30 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Covid19Studies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amanda Rao, PhD, Principal investigator, RDC Clinical Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795816
- Sponsor's protocol ID
- FENCOV
- Status last verified
- Oct 2024
- First submitted
- 27 Mar 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Testofen on Energy, Fatigue, Mental Acuity, and Other Quality of Life Symptoms Post COVID-19 Infection
- ClinicalTrials.gov ID
- NCT05795816
- Acronym / sponsor ID
- FENCOV
- Conditions
- Long Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testofen | Active comparator | Drug: TestofenTestofen in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening) |
| Microcrystalline cellulose | Placebo comparator | Drug: Microcrystalline celluloseMicrocrystalline cellulose in capsule form - taken as per Active comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestofenTwice daily dose of 1 capsule (300mg per capsule Testofen) | Drug | Testofen |
| Microcrystalline celluloseTwice daily dose of 1 capsule | Drug | Microcrystalline cellulose |
Primary outcome
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
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
12 secondary outcomes
Change in Memory
Time frame: Baseline, week 4, week 8 and week 12
Change in Mental Acuity
Time frame: Baseline, week 4, week 8 and week 12
Change in Muscle Strength (Hand grip)
Time frame: Baseline, week 4, week 8 and week 12
Change in Hair loss/growth
Time frame: Baseline, week 4, week 8 and week 12
Change in Libido
Time frame: Baseline, week 4, week 8 and week 12
Change in Stress and Mood
Time frame: Baseline, week 4, week 8 and week 12
Change in Quality of Life Indicators
Time frame: Baseline, week 4, week 8 and week 12
Change in Pathology results via Blood test
Time frame: Baseline, week 4, week 8 and week 12
Change in Weight
Time frame: Baseline, week 4, week 8 and week 12
Height
Time frame: Baseline, week 4, week 8 and week 12
Change in Safety as assessed by Adverse Events Recording
Time frame: During enrolment period
Change in safety markers as assessed by pathology
Time frame: Baseline, week 4, week 8 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Rao, PhD principal investigator
RDC Clinical Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testofen and Microcrystalline cellulose in people with Long Covid19, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Energy and Fatigue (time frame: Baseline, week 4, week 8 and week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.