Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: HDC; Placebo solution
Intervention description: (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X),10 drops t.i.d. for 15 weeks.; 10 drops, t.i.d, 15 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: low-back; pain; chronic; constitution; diathesism; homoeopathy; fixed combination; herbal preparation; chronic low back pain lasting more than 6 months

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.
    

Eligibility 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