Rare diseases
Investigational molecules
Locations
The full name of this substance is refined and quantified dry extract of Ginkgo biloba leaves (35-67:1) quantified to 22.0 to 27.0 % of flavonoids expressed as flavone glycosides, 2.8 to 3.4 % of ginkgolides A, B and C, and 2.6 to 3.2 % of bilobalide, with acetone 60% (m/m) as the extraction solvent. It is a standardised plant extract prepared from the leaves of the Ginkgo biloba tree.[1] In the trial registry it appears as the film-coated tablet product Tebonin konzent 240 mg, supplied by Dr. Willmar Schwabe GmbH & Co.
The extract is standardised to contain defined amounts of flavonoids, ginkgolides and bilobalide. These are naturally occurring constituents of ginkgo leaves. The trial data do not describe the molecular mechanism of action in detail. The extract was studied for its effect on cognitive outcomes in people with cognitive impairment associated with post COVID-19 syndrome.[1]
The product used in the trial is a film-coated tablet for oral use.[1] In the trial, the dose studied was 240 mg once daily, given for up to 12 weeks.[1] The comparison arm received a film-coated, round, yellow tablet with no active substance (placebo).[1]
The registry contains one completed Phase 2 interventional trial of this extract, with 400 participants.[1] The trial compared Tebonin konzent 240 mg taken once daily against placebo in participants with cognitive impairment associated with post COVID-19 syndrome.[1] The primary outcomes included changes from baseline to week 6 and week 12 on several cognitive tests: the digit span forward and backward test, a verbal fluency test, the trail making test (TMT A and B), the California Verbal Learning Test (CVLT) and the d2-R test of attention.[1] The trial also measured changes in anxiety and depression questionnaires (GAD-7 and PHQ-9), an 11-point box scale for vertigo and tinnitus, and other scales including the Clinical Global Impression severity and improvement scales (CGI-S and CGI-I), the post-COVID functional status scale (PCFSS), the Modified Fatigue Impact Scale (MFIS), the modified post-exertional malaise DePaul Symptom Questionnaire (mPEM-DSQ) and the SBQ-LC test.[1] Safety was assessed by recording the number of patients with adverse events (AEs), adverse drug reactions (ADRs) and serious adverse events (SAEs).[1] The trial status is completed, meaning the study has finished.[1]
The registered trial enrolled participants with cognitive impairment associated with post COVID-19 syndrome.[1] The trial is completed, so it is no longer recruiting. The record does not list further inclusion or exclusion criteria in the data provided.[1]
The registry record lists the number of patients with adverse events, adverse drug reactions and serious adverse events as a safety outcome of the trial.[1] The data provided do not describe the specific side effects observed. No supplementary safety information is available in the sources for this page.
Each condition opens its own overview and trial list
Recruiting trials first
Tell us about your condition – we search every trial in Europe and connect you with the right site.
