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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Naja-comp.
Placebo
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke rehabilitation, outcome, barthel-index, geriatrics, elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • KWA Stift Rottal
  • Alexander von Humdoldt-Klijnik
  • Kreiskrankenhaus Haag - Fachklinik für Geriatrische Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Naja-comp.

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

barthel-index
rate of unplanned discharge to hospital care

Secondary Outcome Measures

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

Full Information

First Posted
October 7, 2009
Last Updated
December 10, 2020
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01048411
Brief Title
Trial to Investigate the Influence of the Homeopathic Remedy Naja-comp on Stroke Therapy in Geriatric Rehabilitation
Acronym
naja-comp
Official Title
Multicenter Randomized Controlled Trial to Investigate the Influence of the Homeopathic Remedy 'Naja-comp' on Stroke Therapy in Geriatric Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
Secondary outcome for functional improvement are Scandinavian Stroke Scale, 4D+S-Scale and Timed-Up&Go-Test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke rehabilitation, outcome, barthel-index, geriatrics, elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naja-comp.
Arm Type
Active Comparator
Arm Description
s.c. injection of naja comp (homeopathic remedy) three times a week
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
s.c. injection of placebo (NaCl-solution) three times a week
Intervention Type
Drug
Intervention Name(s)
Naja-comp.
Other Intervention Name(s)
Naja compositum
Intervention Description
homeopathic remedy
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NaCl 0.9%
Intervention Description
s.c. injection of NaCl-solution three times a week
Primary Outcome Measure Information:
Title
barthel-index
Time Frame
baseline, 21st day of rehabilitation
Title
rate of unplanned discharge to hospital care
Time Frame
until day 21 of rehabilitation
Secondary Outcome Measure Information:
Title
Scandinavian Stroke Scale, 4D+S-Scale, Timed-Up&Go-Test
Time Frame
baseline, 21st day of rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornel Sieber, Professor
Organizational Affiliation
Univerity of Erlangen-Nuernberg, Director of the Institute for Biomedicine of Aging
Official's Role
Study Chair
Facility Information:
Facility Name
KWA Stift Rottal
City
Bad Griesbach
State/Province
Bavaria
ZIP/Postal Code
D-94086
Country
Germany
Facility Name
Alexander von Humdoldt-Klijnik
City
Bad Steben
State/Province
Bavaria
ZIP/Postal Code
D-95138
Country
Germany
Facility Name
Kreiskrankenhaus Haag - Fachklinik für Geriatrische Rehabilitation
City
Haag in Oberbayern
State/Province
Bavaria
ZIP/Postal Code
D-83527
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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