|
|
|
|
|
|
Sponsors and Collaborators: |
Charite University, Berlin, Germany WALA Heilmittel GmbH |
Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00567736 |
The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain compared to waiting list group, or placebo.
Condition | Intervention | Phase |
Chronic Low Back Pain |
Drug: Disci/Rhus toxicodendron comp.® Drug: placebo solution |
Phase III |
MedlinePlus related topics: | Back Pain |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group |
Estimated Enrollment: | 150 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Disci/Rhus toxicodendron comp.®
|
Drug: Disci/Rhus toxicodendron comp.®
s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
|
2: Placebo Comparator
placebo solution
|
Drug: placebo solution
s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
|
3: No Intervention
waiting list group
|
Chronic low back pain is a significant health problem in industrialized countries. Use of complementary medicine is increasing in patients with low back pain. Until now there is no evidence for the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain.
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center | |||||
Berlin, Germany, 10117 |
Charite University, Berlin, Germany |
WALA Heilmittel GmbH |
Principal Investigator: | Claudia M Witt, MD | Institute for Social Medicine, Epidemiology, and Health Economics - Charité University Medical Center |
Responsible Party: | Charité University Medical Center Berlin ( Institute for Social Medicine, Epidemiology, and Health Economics ) |
Study ID Numbers: | DISCI-07, EudraCT-Nr. 2006-006390-24 |
First Received: | December 4, 2007 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00567736 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
|
|