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

NCT ID: NCT01048411

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Stroke

Keywords

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stroke rehabilitation outcome barthel-index geriatrics elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Naja-comp.

s.c. injection of naja comp (homeopathic remedy) three times a week

Group Type ACTIVE_COMPARATOR

Naja-comp.

Intervention Type DRUG

homeopathic remedy

Placebo

s.c. injection of placebo (NaCl-solution) three times a week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

s.c. injection of NaCl-solution three times a week

Interventions

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Naja-comp.

homeopathic remedy

Intervention Type DRUG

Placebo

s.c. injection of NaCl-solution three times a week

Intervention Type DRUG

Other Intervention Names

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Naja compositum NaCl 0.9%

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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University of Erlangen-Nuernberg, Institute for Biomedicine of Aging

Principal Investigators

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Cornel Sieber, Professor

Role: STUDY_CHAIR

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

Locations

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KWA Stift Rottal

Bad Griesbach, Bavaria, Germany

Site Status

Alexander von Humdoldt-Klijnik

Bad Steben, Bavaria, Germany

Site Status

Kreiskrankenhaus Haag - Fachklinik für Geriatrische Rehabilitation

Haag in Oberbayern, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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2004-001760-46

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

naja-comp-1-trial

Identifier Type: -

Identifier Source: org_study_id