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NCT01048411 Clinical Trial

Trial to Investigate the Influence of the Homeopathic Remedy Naja-comp on Stroke Therapy in Geriatric Rehabilitation

Stroke Clinical Trial

— naja-comp  

Official title:
Multicenter Randomized Controlled Trial to Investigate the Influence of the Homeopathic Remedy 'Naja-comp' on Stroke Therapy in Geriatric Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01048411
Other study ID # naja-comp-1-trial
Secondary ID 2004-001760-46
Status Completed
Phase N/A
First received
Last updated
Start date January 2006
Est. completion date August 2009

Study information
Verified date December 2020
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The homeopathic remedy 'naja-comp' will improve functional outcome measured by the Barthel-Index. The homeopathic remedy 'naja-comp' will decrease complications during geriatric rehabilitation measured by rate of unplanned discharge to hospital.

Description:

Secondary outcome for functional improvement are Scandinavian Stroke Scale, 4D+S-Scale and Timed-Up&Go-Test.

Recruitment information / eligibility
Status Completed
Enrollment 344
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - stroke within 60 days after onset Exclusion Criteria: - stroke by injury or tumor - stroke older than 60 days - missing consent for participation - participation at other clinical trials

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Naja-comp.
homeopathic remedy
• Placebo
s.c. injection of NaCl-solution three times a week

Locations
Country Name City State
Germany KWA Stift Rottal Bad Griesbach Bavaria
Germany Alexander von Humdoldt-Klijnik Bad Steben Bavaria
Germany Kreiskrankenhaus Haag - Fachklinik für Geriatrische Rehabilitation Haag in Oberbayern Bavaria

Sponsors (1)
Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary barthel-index baseline, 21st day of rehabilitation
Primary rate of unplanned discharge to hospital care until day 21 of rehabilitation
Secondary Scandinavian Stroke Scale, 4D+S-Scale, Timed-Up&Go-Test baseline, 21st day of rehabilitation
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