Brief description of trial (Data source: BASEC)
Angst gehört zum Leben. Wenn Angstsymptome jedoch überhandnehmen und ein normales Mass überschreiten, kann dies die Lebensqualität und der Alltag der Betroffenen stark beeinträchtigen. Sie verspüren körperliche und psychische Leiden. In der anthroposophischen Medizin wird Bryophyllum oft bei psychischen Erkrankungen angewendet, sehr häufig zur Behandlung von Angst -und Schlafstörungen.
In der vorliegenden Studie wird die Wirkung von Bryophyllum pinnatum auf Angstsymptome untersucht. Da Angstsymptome häufig mit Depressionen, schlechter Schlafqualität, Stress und verminderter Lebensqualität zusammenhängen, werden auch diese Aspekte bewertet.
Anhand von Fragebögen, die vor und nach 2-und 3-wöchiger Einnahme von Bryophyllum ausgefüllt werden, untersuchen wir, ob PatientInnen, die unter Angstsymptomen leiden, eine Verbesserung dieser Symptome während der Behandlung mit Bryophyllum pinnatum wahrnehmen.
Health conditions investigated(Data source: BASEC)
Patienten mit Angstsymptomen
Health conditions
(Data source: WHO)
Anxiety Symptoms
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Medikament: Bryophyllum 50 % Kautabletten
Interventions
(Data source: WHO)
Drug: Bryophyllum 50 % Chewing Tablets
Criteria for participation in trial
(Data source: BASEC)
- Patienten, die von ihrem behandelnden Arzt an die Abteilung für Psychiatrie und Psychosomatik der Klinik Arlesheim überwiesen werden und auf den stationären Aufenthalt warten
- Patienten mit Angstsymptomen, gemessen mit dem GAD-2 (Generalized Anxiety Disorder) Fragebogen
- Keine geplante Dosiserhöhung oder Einnahme von neuen (konventionellen) Anxiolytika oder Antidepressiva während der Studienzeit
Exclusion criteria
(Data source: BASEC)
- Akute lebensbedrohliche Zustände
- Weizenallergie
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Patients referred by their treating physician to the Department of Psychiatry and
Psychosomatic of the Clinic Arlesheim waiting for the in-stay
- Expected waiting time until in-stay is at least two weeks
- Patients having anxiety symptoms as measured by the GAD-2 questionnaire (cut-off of
3 points)
- Patients'state of health allows them to complete the questionnaire on their own
- Signed informed consent
- No treatment with BP during the last two months
- No planned doses increase of (conventional) anxiolytics or antidepressants for the
duration of the period until in-stay
- Age over 18 years
- Good German knowledge (at least level B2 from Common European Framework of Reference
for Languages)
Exclusion Criteria:
- Wheat allergies
- Acute life-threatening conditions
- Withdrawal of informed consent
-
Further information on trial
Recruitment status
Completed
Academic title
(Data source: WHO)
Perceived Changes in Anxiety Symptom Burden During Treatment With Bryophyllum Pinnatum and Tolerability: a Prospective, Single-Group Pre-post Observational Study as Investigator-Initiated Trial (IIT)
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 4
Primary end point
(Data source: WHO)
Change of anxiety symptoms
Secundary end point
(Data source: WHO)
Change of anxiety symptoms;Change of depression symptoms;Change of stress symptoms;Change in sleep quality;Change in health-related quality of life questionnaire;Change in the Sense of Coherence;Brophyllum Prescription report
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Arlesheim
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. med. Markus Schlemmer
+41 (0)61 705 72 81
markus.schlemmer@klinik-arlesheim.ch
Contact for general information
(Data source: WHO)
Markus Schlemmer, Dr. med.
Klinik Arlesheim, Pfeffingerweg1, 4144 Arlesheim, Switzerland
Contact for scientific information
(Data source: WHO)
Markus Schlemmer, Dr. med.
Klinik Arlesheim, Pfeffingerweg1, 4144 Arlesheim, Switzerland
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
11.05.2021
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2021-00617
Secondary ID (Data source: WHO)
Bryo-KLA-02
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