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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05795816




Registration number
NCT05795816
Ethics application status
Date submitted
27/03/2023
Date registered
3/04/2023
Date last updated
18/10/2024

Titles & IDs
Public title
Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms
Scientific title
The Effectiveness of Testofen on Energy, Fatigue, Mental Acuity, and Other Quality of Life Symptoms Post COVID-19 Infection
Secondary ID [1] 0 0
FENCOV
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long Covid19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Testofen
Treatment: Drugs - Microcrystalline cellulose

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)

Placebo comparator: Microcrystalline cellulose - Microcrystalline cellulose in capsule form - taken as per Active comparator


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

Treatment: Drugs: Microcrystalline cellulose
Twice daily dose of 1 capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Energy and Fatigue
Timepoint [1] 0 0
Baseline, week 4, week 8 and week 12
Primary outcome [2] 0 0
Change in Energy and Fatigue
Timepoint [2] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [1] 0 0
Change in Memory
Timepoint [1] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [2] 0 0
Change in Mental Acuity
Timepoint [2] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [3] 0 0
Change in Muscle Strength (Hand grip)
Timepoint [3] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [4] 0 0
Change in Hair loss/growth
Timepoint [4] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [5] 0 0
Change in Libido
Timepoint [5] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [6] 0 0
Change in Stress and Mood
Timepoint [6] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [7] 0 0
Change in Quality of Life Indicators
Timepoint [7] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [8] 0 0
Change in Pathology results via Blood test
Timepoint [8] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [9] 0 0
Change in Weight
Timepoint [9] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [10] 0 0
Height
Timepoint [10] 0 0
Baseline, week 4, week 8 and week 12
Secondary outcome [11] 0 0
Change in Safety as assessed by Adverse Events Recording
Timepoint [11] 0 0
During enrolment period
Secondary outcome [12] 0 0
Change in safety markers as assessed by pathology
Timepoint [12] 0 0
Baseline, week 4, week 8 and week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05795816
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Rao, PhD
Address 0 0
RDC Clinical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 414 488 559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05795816