Effectiveness of Testofen Compared to Placebo on Long COVID Symptoms

RDC Clinical

Status and phase: Completed; Phase 3

Conditions: Long Covid19

Treatments: Drug: Testofen; Drug: Microcrystalline cellulose

Study type: Interventional

Funder types: Industry

Identifiers

NCT05795816

FENCOV

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Testofen

Active Comparator group

Description:

Testofen in capsule form - taken as 2 x 300 mg daily with food (1 in the morning and 1 in the evening)

Treatment:

Drug: Testofen

Microcrystalline cellulose

Placebo Comparator group

Description:

Microcrystalline cellulose in capsule form - taken as per Active comparator

Treatment:

Drug: Microcrystalline cellulose