Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Long Covid19
• Intervention / Treatment: Drug: Testofen; Drug: Microcrystalline cellulose

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • RDC Clinical Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 per Active comparator	Drug: Microcrystalline cellulose; Twice daily dose of 1 capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Baseline, week 4, week 8 and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Memory	Change in Memory as measured by Short Term Memory testing	Baseline, week 4, week 8 and week 12
Change in Mental Acuity	Change in Mental acuity as measured by Reaction Time Test	Baseline, week 4, week 8 and week 12
Change in Muscle Strength (Hand grip)	Change in Muscle Strength (Hand grip) as measured by Dynamometer	Baseline, week 4, week 8 and week 12
Change in Hair loss/growth	Change in Hair loss/growth as measured by Hair loss questionnaire	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)	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)	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	Baseline, week 4, week 8 and week 12
Change in Weight	Change in Weight as measured by scales in kg	Baseline, week 4, week 8 and week 12
Height	Height as measured by tape measure in centimetres	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	During enrolment period
Change in safety markers as assessed by pathology	Change in safety markers E/LFT as assessed by pathology	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	Baseline, week 4, week 8 and week 12

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Investigators: Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: FENCOV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No