Randomized, placebo-controlled, double-blind study to evaluate the efficacy of 2LEBV® and 2LXFS® on asthenia in patients with an EBV infection

Conditions

Epstein-Barr Virus infection

Brief summary

The general fatigue scale of the MFI-20 questionnaire at the end of the treatment (6-month visit - V4)

Detailed description

- Physical fatigue, reduced activity, reduced motivation and mental fatigue scales on the MFI-20 questionnaire at V4, - 5 scales on the MFI-20 questionnaire at V3 and V5, - Other EBV infection-related symptoms: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivitis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsil, headaches, sore throat, myalgia, muscular weakness, arthralgia, splenomegaly, visual disorders, memory disorders, attention deficit disorders, sleep disorders, gastrointestinal disorders, breathing disorders, cardiovascular disorders at V3, V4 and V5, - Lymphocytes typing and immune status (normo, hypo or hyperactive immune system) at V1, V3, V4 and V5, - IgG anti-EA, anti-VCA, anti-EBNA and IgM anti-VCA at V0, V1 and V4, - Safety: Occurrence of Adverse Events (AEs) and Severe Adverse Events (SAEs), considered as related or not to the study drug.

Related papers

No related papers found yet.

Interventions

DRUGPlacebo

DRUG2LEBV granules en gélules à ouvrir

DRUG2LXFS

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The general fatigue scale of the MFI-20 questionnaire at the end of the treatment (6-month visit - V4)	—

Secondary

Measure	Time frame
- Physical fatigue, reduced activity, reduced motivation and mental fatigue scales on the MFI-20 questionnaire at V4, - 5 scales on the MFI-20 questionnaire at V3 and V5, - Other EBV infection-related symptoms: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivitis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsil, headaches, sore throat, myalgia, muscular weakness, arthralgia, splenomegaly, visual disorders, memory disorders, attention deficit disorders, sleep disorders, gastrointestinal disorders, breathing disorders, cardiovascular disorders at V3, V4 and V5, - Lymphocytes typing and immune status (normo, hypo or hyperactive immune system) at V1, V3, V4 and V5, - IgG anti-EA, anti-VCA, anti-EBNA and IgM anti-VCA at V0, V1 and V4, - Safety: Occurrence of Adverse Events (AEs) and Severe Adverse Events (SAEs), considered as related or not to the study drug.	—

Measure

Time frame

- Physical fatigue, reduced activity, reduced motivation and mental fatigue scales on the MFI-20 questionnaire at V4, - 5 scales on the MFI-20 questionnaire at V3 and V5, - Other EBV infection-related symptoms: Long-lasting exhaustion even after light exertion, subfebrile state, fever, loss of appetite, nausea, angina, conjunctivitis, sensitive cervical or axillary lymph nodes, erythematous and swollen tonsil, headaches, sore throat, myalgia, muscular weakness, arthralgia, splenomegaly, visual disorders, memory disorders, attention deficit disorders, sleep disorders, gastrointestinal disorders, breathing disorders, cardiovascular disorders at V3, V4 and V5, - Lymphocytes typing and immune status (normo, hypo or hyperactive immune system) at V1, V3, V4 and V5, - IgG anti-EA, anti-VCA, anti-EBNA and IgM anti-VCA at V0, V1 and V4, - Safety: Occurrence of Adverse Events (AEs) and Severe Adverse Events (SAEs), considered as related or not to the study drug.

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Countries

Belgium

Outcome results

None listed