Trial to Investigate the Influence of the Homeopathic Rem... | NCT01048411

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

NCT01048411

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Completed

Last Update Posted

Dec 14, 2020Actual

Enrollment

344Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

Naja-comp.
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2004-001760-46	EudraCT Number

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Oct 7, 2009

First Submission Date that Met QC Criteria

Jan 12, 2010

First Posted Date

Jan 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2020

Last Update Posted Date

Dec 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

344Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Naja-comp.	Drug	homeopathic remedy	Naja-comp.	Naja compositum

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cornel Sieber, Professor	Univerity of Erlangen-Nuernberg, Director of the Institute for Biomedicine of Aging	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KWA Stift Rottal		Bad Griesbach	Bavaria	D-94086	Germany
Alexander von Humdoldt-Klijnik

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided