Back to resultsEffectiveness of Testofen Compared to Placebo on Long COVID Symptoms
Primary Purpose
Long Covid19
Status
Not yet recruiting
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Testofen
Microcrystalline cellulose
Sponsored by
About this trial
This is an interventional treatment trial for Long Covid19
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 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.
Sites / Locations
- RDC Clinical Pty Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Testofen
Microcrystalline cellulose
Arm Description
Testofen in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening)
Microcrystalline cellulose in capsule form - taken as per Active comparator
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Change in Memory
Change in Memory as measured by Short Term Memory testing
Change in Mental Acuity
Change in Mental acuity as measured by Reaction Time Test
Change in Muscle Strength (Hand grip)
Change in Muscle Strength (Hand grip) as measured by Dynamometer
Change in Hair loss/growth
Change in Hair loss/growth as measured by Hair loss questionnaire
Change in Libido
Change in Libido as measured by - If male, DISF-SR (Derogatis Sexual Function Index), If female, FSFI (Female Sexual Function Index)
Change in Stress and Mood
Change in Stress and Mood via Depression Anxiety and Stress Scale (DASS-21)
Change in Quality of Life Indicators
Change in Quality of Life Indicators via Symptom Burden Questionnaire - Long Covid
Change in Pathology results via Blood test
Change in Pathology results (Full blood count (including platelet aggregation), 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
Change in Weight
Change in Weight as measured by scales in kg
Height
Height as measured by tape measure in centimetres
Change in Safety as assessed by Adverse Events Recording
Change in Safety as assessed by Adverse Events Recording
Change in safety markers as assessed by pathology
Change in safety markers E/LFT as assessed by pathology
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05795816
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RDC Clinical Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Testofen
Arm Type
Active Comparator
Arm Description
Testofen in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening)
Arm Title
Microcrystalline cellulose
Arm Type
Placebo Comparator
Arm Description
Microcrystalline cellulose in capsule form - taken as per Active comparator
Intervention Type
Drug
Intervention Name(s)
Testofen
Intervention Description
Twice daily dose of 1 capsule (300mg per capsule Testofen)
Intervention Type
Drug
Intervention Name(s)
Microcrystalline cellulose
Intervention Description
Twice daily dose of 1 capsule
Primary Outcome Measure Information:
Title
Change in Energy and Fatigue
Description
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
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change in Energy and Fatigue
Description
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
Time Frame
Baseline, week 4, week 8 and week 12
Secondary Outcome Measure Information:
Title
Change in Memory
Description
Change in Memory as measured by Short Term Memory testing
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change in Mental Acuity
Description
Change in Mental acuity as measured by Reaction Time Test
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change in Muscle Strength (Hand grip)
Description
Change in Muscle Strength (Hand grip) as measured by Dynamometer
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change in Hair loss/growth
Description
Change in Hair loss/growth as measured by Hair loss questionnaire
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change in Libido
Description
Change in Libido as measured by - If male, DISF-SR (Derogatis Sexual Function Index), If female, FSFI (Female Sexual Function Index)
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change in Stress and Mood
Description
Change in Stress and Mood via Depression Anxiety and Stress Scale (DASS-21)
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change in Quality of Life Indicators
Description
Change in Quality of Life Indicators via Symptom Burden Questionnaire - Long Covid
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change in Pathology results via Blood test
Description
Change in Pathology results (Full blood count (including platelet aggregation), 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
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change in Weight
Description
Change in Weight as measured by scales in kg
Time Frame
Baseline, week 4, week 8 and week 12
Title
Height
Description
Height as measured by tape measure in centimetres
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change in Safety as assessed by Adverse Events Recording
Description
Change in Safety as assessed by Adverse Events Recording
Time Frame
During enrolment period
Title
Change in safety markers as assessed by pathology
Description
Change in safety markers E/LFT as assessed by pathology
Time Frame
Baseline, week 4, week 8 and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Rao, PhD
Phone
+61 414 488 559
Email
amanda@rdcglobal.com.au
First Name & Middle Initial & Last Name or Official Title & Degree
David Briskey, PhD
Phone
+61 421 784 077
Email
david@rdcglobal.com.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Rao, PhD
Organizational Affiliation
RDC Clinical Pty Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
RDC Clinical Pty Ltd
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Rao, PhD
Phone
+61 414 488 559
Email
amanda@rdcglobal.com.au
First Name & Middle Initial & Last Name & Degree
David Briskey, PhD
Phone
+61 421 784 077
Email
david@rdcglobal.com.au
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared
Learn more about this trial
Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms
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