Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back pain in relation to pain, functional impairment, quality of life, and state of health during a 15-week treatment period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pascoe Pharmazeutische Praeparate GmbH

Criteria

Inclusion Criteria:

• Male and female patients

• Aged 18 - 75 years

• Chronic low-back pain lasting at least for 6 months

• Hanover functional ability questionnaire (FFbH-R) score less than 70%

• At least one of the following diagnoses:

1. Chronic lumbar ischialgia with or without radicular radiation

2. Chronic degenerative lumbar syndrome

3. Spondylarthrosis

4. Chronic facet syndrome

5. Lumbago with protrusion of the intervertebral disc

6. Lumbar radiculopathy

7. Lumbar and other intervertebral disc impairments with radiculopathy

8. Back pain at different locations of the spine

• Written, informed consent

Exclusion Criteria:

• Participation in another clinical trial/GCP-trial within 30 days prior to screening

• Participation in this trial in an earlier time

• Treatment with lymphdiaral basistropfen within 3 month prior to enrolment

• Pregnancy and lactation

• Non-compliance

• Incapability to understand the sense of the study

• Abuse of analgesics, opiates or other drugs

• Chronic pain that are as strong as or even stronger than the pain caused by the low-back and that need to be treated with analgesics

• Malign diseases

• Pathological neurological states

• Epilepsy

• Operation of the spine within 3 month prior to enrolment

• Fractures of the spine

• Bechterew's disease

• Alcohol abuse

• Consuming diseases

• Cachexia

• Palsy of the legs or anal sphincter due to acute impairment of the intervertebral disc

• Catheterisation or CT-controlled intra-articular injection in the lumbar region

• Hypersensitivity against one of the ingredients or excipients of the study drugs or against composite plants in general

• Systemic, progressive diseases like tuberculosis, leucosis, collagenosis, multiple sclerosis, acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV) infection, or other auto-immune diseases