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

Sponsor:	University of Erlangen-Nürnberg Medical School
Information provided by:	University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:	NCT01048411

Purpose

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.

Condition	Intervention
Stroke	Drug: Naja-comp. Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Multicenter Randomized Controlled Trial to Investigate the Influence of the Homeopathic Remedy 'Naja-comp' on Stroke Therapy in Geriatric Rehabilitation

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:

barthel-index [ Time Frame: baseline, 21st day of rehabilitation ] [ Designated as safety issue: No ]
rate of unplanned discharge to hospital care [ Time Frame: until day 21 of rehabilitation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Scandinavian Stroke Scale, 4D+S-Scale, Timed-Up&Go-Test [ Time Frame: baseline, 21st day of rehabilitation ] [ Designated as safety issue: No ]

Enrollment:	344
Study Start Date:	January 2006
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Naja-comp. s.c. injection of naja comp (homeopathic remedy) three times a week	Drug: Naja-comp. homeopathic remedy Other Name: Naja compositum
Placebo Comparator: Placebo s.c. injection of placebo (NaCl-solution) three times a week	Drug: Placebo s.c. injection of NaCl-solution three times a week Other Name: NaCl 0.9%

Detailed Description:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048411

Locations

Germany
KWA Stift Rottal
Bad Griesbach, Bavaria, Germany, D-94086
Alexander von Humdoldt-Klijnik
Bad Steben, Bavaria, Germany, D-95138
Kreiskrankenhaus Haag - Fachklinik für Geriatrische Rehabilitation
Haag in Oberbayern, Bavaria, Germany, D-83527

Sponsors and Collaborators

University of Erlangen-Nürnberg Medical School

Investigators

Study Chair:

Cornel Sieber, Professor

Univerity of Erlangen-Nuernberg, Director of the Institute for Biomedicine of Aging

More Information

No publications provided

Responsible Party:	Prof. Dr. Cornel Sieber, University of Erlangen-Nuernberg, Institute for Biomedicine of Aging
ClinicalTrials.gov Identifier:	NCT01048411 History of Changes
Other Study ID Numbers:	naja-comp-1-trial, 2004-001760-46
Study First Received:	October 7, 2009
Last Updated:	January 12, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:

stroke rehabilitation
outcome
barthel-index
geriatrics
elderly

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2012