NCT01048411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

3.6 years

First QC Date

October 7, 2009

Last Update Submit

December 10, 2020

Conditions

Stroke

Keywords

stroke rehabilitationoutcomebarthel-indexgeriatricselderly

Outcome Measures

Primary Outcomes (2)

  • barthel-index

    baseline, 21st day of rehabilitation

  • rate of unplanned discharge to hospital care

    until day 21 of rehabilitation

Secondary Outcomes (1)

  • Scandinavian Stroke Scale, 4D+S-Scale, Timed-Up&Go-Test

    baseline, 21st day of rehabilitation

Study Arms (2)

Naja-comp.

ACTIVE COMPARATOR

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

Drug: Naja-comp.

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Naja-comp.DRUG

homeopathic remedy

Also known as: Naja compositum
Naja-comp.
PlaceboDRUG

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

Also known as: NaCl 0.9%
Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • stroke within 60 days after onset

You may not qualify if:

  • stroke by injury or tumor
  • stroke older than 60 days
  • missing consent for participation
  • participation at other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

KWA Stift Rottal

Bad Griesbach, Bavaria, D-94086, Germany

Location

Alexander von Humdoldt-Klijnik

Bad Steben, Bavaria, D-95138, Germany

Location

Kreiskrankenhaus Haag - Fachklinik für Geriatrische Rehabilitation

Haag in Oberbayern, Bavaria, D-83527, Germany

Location

MeSH Terms

Conditions

Stroke

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Cornel Sieber, Professor

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2009

First Posted

January 13, 2010

Study Start

January 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

DE(3)