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Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain (144)

P

Pascoe Natural Healthcare

Status and phase

Completed
Phase 3

Conditions

Low Back Pain

Treatments

Drug: Placebo solution
Drug: HDC

Study type

Interventional

Funder types

Industry

Identifiers

NCT01049373
ISRCTN88642122 (Registry Identifier)
PSC144/03

Details and patient eligibility

About

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.

Full 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.

Enrollment

221 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

221 participants in 2 patient groups, including a placebo group

Lymphdiaral Basistropfen (HDC)
Experimental group
Description:
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.
Treatment:
Drug: HDC
Placebo Solution
Placebo Comparator group
Description:
10 drops t.i.d. for 15 weeks
Treatment:
Drug: Placebo solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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