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

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Completed

CT.gov ID

NCT01048411

Collaborator

(none)

344

Enrollment

Locations

Arms

Duration (Months)

114.7

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: Naja-comp. Drug: Placebo	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

344 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Naja-comp. s.c. injection of naja comp (homeopathic remedy) three times a week	Drug: Naja-comp. homeopathic remedy Other Names: 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 Names: NaCl 0.9%

Arm

Intervention/Treatment

Active Comparator: Naja-comp.

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

Drug: Naja-comp.

homeopathic remedy

Other Names:

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 Names:

NaCl 0.9%

Outcome Measures

Primary Outcome Measures

barthel-index [baseline, 21st day of rehabilitation]
rate of unplanned discharge to hospital care [until day 21 of rehabilitation]

Secondary Outcome Measures

Scandinavian Stroke Scale, 4D+S-Scale, Timed-Up&Go-Test [baseline, 21st day of rehabilitation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KWA Stift Rottal	Bad Griesbach	Bavaria	Germany	D-94086
2	Alexander von Humdoldt-Klijnik	Bad Steben	Bavaria	Germany	D-95138
3	Kreiskrankenhaus Haag - Fachklinik für Geriatrische Rehabilitation	Haag in Oberbayern	Bavaria	Germany	D-83527