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

NCT ID: NCT01049373

Last Updated: 2012-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2007-05-31

Brief 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.

Detailed Description

Low-back pain is often provoked by inflammatory edema in the region of the facet joints. In naturopathy, a fixed homeopathic drug combination (HDC) is established in the treatment of edema and swellings. For the first time, the efficacy of HDC was investigated in the treatment of low-back pain.

Objective: To examine the efficacy and safety of HDC medication vs. placebo in the treatment of chronic low back pain considering constitution and diathesism in a double-blind, randomized controlled clinical trial.

Conditions

Low Back Pain

Keywords

low-back; pain; chronic; constitution; diathesism; homoeopathy; fixed combination; herbal preparation; chronic low back pain lasting more than 6 months

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lymphdiaral Basistropfen (HDC)

HDC (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), each 10 drops t.i.d. for 15 weeks.

Group Type: EXPERIMENTAL

HDC

Intervention Type: DRUG

(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.

Placebo Solution

10 drops t.i.d. for 15 weeks

Group Type: PLACEBO_COMPARATOR

Placebo solution

Intervention Type: DRUG

10 drops, t.i.d, 15 weeks

Interventions

HDC

(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.

Intervention Type: DRUG

Placebo solution

10 drops, t.i.d, 15 weeks

Intervention Type: DRUG

Other Intervention Names

Lymphdiaral Basistropfen

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pascoe Pharmazeutische Praeparate GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andre M Beer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of True Naturopathy, Blankenstein Hospital; Im Vogelsang 5-11; D-45527 Hattingen; Germany;

Juergen Kraemer, Prof

Role: STUDY_DIRECTOR

St. Josef Hospital. Gudrunstr. 56, 44791 Bochum, Germany

Anja Braschoss, MD

Role: STUDY_CHAIR

Pascoe Pharmazeutische Praeparate GmbH

Locations

Department of Naturopathy, Blankenstein Hospital

Hattingen, , Germany

Countries

Germany

Other Identifiers

ISRCTN88642122

Identifier Type: REGISTRY

Identifier Source: secondary_id

PSC144/03

Identifier Type: -

Identifier Source: org_study_id