ISRCTN31235821 Clinical Trial
An ISRCTN31235821 Clinical Trial is an Exploratory Clinical Trial that studies the effects of Rhodiola rosea treatment in patients suffering from burnout symptoms.
- AKA: Exploratory Clinical Trial with Rhodiola Rosea Extract in Patients Suffering from Burnout Symptoms.
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- See: Clinical Trial, Decentralized Clinical Trial, Adaptive Clinical Trial, Confirmatory Clinical Trial, Pragmatic Clinical Trial, Adverse Event.
References
2017
- (Kasper & Dienel, 2017) ⇒ Siegfried Kasper, and Angelika Dienel (2017). "Multicenter, open-label, exploratory clinical trial with Rhodiola rosea extract in patients suffering from burnout symptoms". In: Neuropsychiatric Disease and Treatment, 13, 889. DOI:10.2147/NDT.S120113.
- QUOTE: The trial presented in this study is the first to investigate the clinical outcomes of the drug treatment in patients suffering from burnout syndrome. The principal objective of the trial was therefore to describe the therapeutic impacts as well as the safety and tolerability of R. rosea extract applied in this target group, thus providing exploratory data as a basis for future randomized trials(...)
According to its exploratory design, which aimed to evaluate the study data on a descriptive level, the trial was set up as an open-label, single-arm, multicenter study. Control groups and randomization were therefore unnecessary. The trial was conducted at four centers in Vienna (Austria): Vienna University Hospital and three GP practices. Signed informed consent was obtained from the participants before any trial-related action was performed. The clinical trial number for this study is ISRCTN31235821. The clinical trial was approved by the Ethikkommission der Medizinischen Universität Wien und des AKH, Borschkegasse 8b/E06, A-1090 Wien, Vienna, Austria, which officiated as the responsible ethics committee. Planning, execution, and analysis of the trial were carried out in accordance with national regulations in Austria and the ICH Guidelines for Good Clinical Practice (GCP).
- QUOTE: The trial presented in this study is the first to investigate the clinical outcomes of the drug treatment in patients suffering from burnout syndrome. The principal objective of the trial was therefore to describe the therapeutic impacts as well as the safety and tolerability of R. rosea extract applied in this target group, thus providing exploratory data as a basis for future randomized trials(...)