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

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: Stroke

Treatments: Drug: Naja-comp.; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01048411

2004-001760-46 (EudraCT Number)

naja-comp-1-trial

Details and patient eligibility

About

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.

Full description

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

Enrollment: 344 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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344 participants in 2 patient groups, including a placebo group

Naja-comp.

Active Comparator group

Description:

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

Treatment:

Drug: Naja-comp.

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo