NEW STUDY ANNOUNCEMENT

Post COVID symptoms Study

Seeking adults aged over 18 who have had COVID-19 infection in the last 12 months and experiencing post COVID symptoms to help assess fenugreek extracts therapeutic efficacy.

Fenugreek extract is a plant derived dietary supplement used to relieve a multitude of health conditions and general wellbeing. This extract has well documented anti-oxidative, anti-inflammatory, anti-microbial, anti-diabetic, anti-obesity, and anti-tumor effects as well as sexual health-promoting effects.

Thank you for your interest in our post COVID symptom study which is investigating the effectiveness of fenugreek extract therapeutic to a placebo. We are looking for healthy adults, over the age of 18, who have had COVID-19 infection in the last 12 months and are experiencing post COVID symptoms to participate in a 12-week study period.

If you experience post COVID symptoms (such as fatigue, cough, chest pain, weakness, joint pain etc.) and interested in plant-based treatment therapies you can register your interest for this study.

How long is the study, and when does it start?

The study will involve approximately 150 adults aged over 18 years who are experiencing post COVID symptoms. Each person will participate for a period of 12 weeks.

During the 12-week study period, participants will be required to attend their local pathology centre (eg. QML), complete symptom burden questionnaires, anthropometry measures, muscle strength test and a short-term memory test at the following 4 timepoints during the study:

  1. Baseline at the start of the study: Pathology blood test, anthropometry measures, symptom-based questionnaires, muscle strength (handgrip) test, memory and mental acuity test (reaction time).
  2. At 4 weeks: Pathology blood test, anthropometry measures, symptom-based questionnaires, muscle strength (handgrip) test, memory and mental acuity test (reaction time).
  3. At 8 weeks: Pathology blood test, anthropometry measures, symptom-based questionnaires, muscle strength (handgrip) test, memory and mental acuity test (reaction time).
  4. At 12 weeks: Pathology blood test, anthropometry measures, symptom-based questionnaires, muscle strength (handgrip) test, memory and mental acuity test (reaction time).

To make the timings of these visits as convenient as possible for you, we are recruiting on a rolling basis which means that your individual start date is flexible. Your involvement in this remote study will be 12 weeks.

Please see below for more information. You can find the eligibility and registration form at the bottom of this page

About the product you’ll help investigate…

For this study, we are assessing the effectiveness of Testofen (Trigonella foenum-graecum) for improved energy, fatigue, mental acuity, and other quality of life symptoms post COVID-19 infection.

Previous clinical studies investigating Testofen report significant changes in improved sexual function, increase in strength, endurance, and muscle mass.

The product will be in capsule form, and participants will be asked to take 2 capsules per day for 12 weeks.

As this study is placebo-controlled, you may or may not be allocated the active product. Once enrolled, participants will be randomly allocated to 1 of 2 groups:
A: Active group
B: Placebo

This means that you will have a 1 in 2 chance of being assigned the placebo (a harmless inactive substance typically used as an additive in food production). During the study period, neither you nor the study investigators will know which product you have been allocated.

Why is this study being conducted?

COVID-19 is a current pandemic that began in 2020 and has affected more than 500 million people worldwide. For acute or mild COVID-19 cases, symptoms usually begin to subside after 1 or 2 weeks. However, depending on the severity of the case, persistent symptoms can last for weeks and up to months after initial infection and is commonly referred to as “Long COVID”. These symptoms are varied, but can include fatigue, cough, chest pain, hair loss, weakness, joint pain, cardiac issues, neurocognitive impairment including memory loss, and decreased quality of life. There is no current definitive treatment and there is limited research into possible treatment therapeutics.

Whilst not specifically targeted, the most common treatment option comprises of anti-inflammatory drugs in order to manage the excessive inflammatory response to the viral infection. Alternatively, fenugreek has been previously documented to exert significant anti-inflammatory and antioxidant activities. As such, based on previous research showing the benefits of these plant-based therapeutics, and the need to find potential treatments for people experiencing symptoms post COVID. The current study is aiming to test the effectiveness of Testofen on post COVID-19 symptoms in an otherwise healthy adult population.

What is required of participants?

Your involvement in the study will be 12 weeks. During this time, you will be required to take the study product each day (2 capsules a day) and complete a blood test, questionnaires, anthropometry measures, memory and muscle strength tests at baseline, 4th week, 8th week and the 12th week of the study to assess the effectiveness of the study product.

Payment

You will be eligible for a $250 reimbursement for your time. The payment will be made via direct deposit to your nominated bank account once all study requirements (12 weeks participation) have been met.

If you are a healthy adult, with post COVID symptoms and would like to participate, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page…we’ll then get in touch to screen you for eligibility.

Study Location

This study is a decentralised study, which means that there are no visits to a central clinic required. At 4 timepoints during the 12-week study, you will be required to simply visit a pathology collection centre (such as QML) that is convenient to you. RDC will provide a referral form and a list of collection locations.

Check if you can take part… study participant requirements.
  • Adult aged over 18 years
  • Have had COVID-19 infection in the last 12 months
  • Experiencing ongoing post COVID symptoms
  • Generally healthy with no uncontrolled serious illnesses
  • Able to commit to the study for the 12-week period
  • Agree not to change current diet/exercise or not to use other dietary supplements other than the test product during entire study period.

Please register your interest by answering the questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.

Ethics approval & privacy… you’ll be in safe, professional hands.

This RDC Clinical study has been approved by the National Institute of Integrative Medicine Human Research Ethics Committee under Approval Number: 0114E_2022. The study is also registered on the clinicaltrials.gov under Registration Number: NCT05795816. Trained Trial Co-ordinators will supervise your progress throughout the study. Your results will be made available to you at the conclusion of the study. Any of your personal information collected during the study will be kept in the strictest confidence.

Register HERE now to help with this study!

Find out if you can join this study by clicking YES or NO on the questions below. If you’re a suitable match the Registration Form appears after question 7.