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

December 10, 2020 updated by: University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

344

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
barthel-index
Time Frame: baseline, 21st day of rehabilitation
baseline, 21st day of rehabilitation
rate of unplanned discharge to hospital care
Time Frame: until day 21 of rehabilitation
until day 21 of rehabilitation

Secondary Outcome Measures

Outcome Measure
Time Frame
Scandinavian Stroke Scale, 4D+S-Scale, Timed-Up&Go-Test
Time Frame: baseline, 21st day of rehabilitation
baseline, 21st day of rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Study Chair: Cornel Sieber, Professor, Univerity of Erlangen-Nuernberg, Director of the Institute for Biomedicine of Aging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • naja-comp-1-trial
  • 2004-001760-46 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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