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Completed

NCT Number: NCT01049373

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

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.

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Key information

Conditions

Low Back Pain Back Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Naturopathy, Blankenstein Hospital

Hattingen, D-45527, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Chronic lumbar ischialgia with or without radicular radiation
  • Chronic degenerative lumbar syndrome
  • Spondylarthrosis
  • Chronic facet syndrome
  • Lumbago with protrusion of the intervertebral disc
  • Lumbar radiculopathy
  • Lumbar and other intervertebral disc impairments with radiculopathy
  • 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

Treatment and study plan

HDC

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.

Other names: Lymphdiaral Basistropfen

Placebo solution

Drug

10 drops, t.i.d, 15 weeks

Primary outcomes

  1. Change in FFbH-R Between Screening and Week 15

    Time frame: between screening and 15 weeks treatment

    Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH "for close to everyday diagnostics of functional impairment by back pain". It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.

    Change in FFbH-R between screening and week 15 Scale ranges from 0 (=worst) to 100(=best)

Secondary outcomes

  1. Change in FFbH-R Between Screening and 2 Weeks

    Time frame: between screening and 2 weeks treatment

    Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH "for close to everyday diagnostics of functional impairment by back pain". It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.

    Change in FFbH-R between screening and 2 weeks Scale ranges from 0 (=worst) to 100(=best)

  2. Change in Pain Score (SES), Subscale "Sensoric Pain"

    Time frame: following 2 weeks treatment

    Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.

    Difference between V1 minus V-1 in the subscale "sensoric pain" Scale ranges from 10(=best) to 40(=worst)

  3. Change in Pain Score (SES), Subscale "Sensoric Pain"

    Time frame: following 15 weeks treatment

    Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.

    Difference between screening and 15 weeks in the subscale "sensoric pain" Scale ranges from 10(=best) to 40(=worst)

  4. Change in Strength of Pain (Visual Analog Scale VAS)

    Time frame: following 2 weeks treatment

  5. Change in Strength of Pain (Visual Analog Scale VAS)

    Time frame: following 15 weeks treatment

  6. Change in State of Health (BF-S)

    Time frame: following 2 weeks treatment

  7. Change in State of Health (BF-S)

    Time frame: following 15 weeks treatment

  8. Change in Oswestry Score

    Time frame: following 2 weeks treatment

  9. Change in Oswestry Score

    Time frame: following 15 weeks treatment

  10. Change in Short Form Health Survey 12 Items (SF-12)

    Time frame: following 2 weeks treatment

  11. Change in Short Form Health Survey 12 Items (SF-12) Ment

    Time frame: following 15 weeks treat

  12. Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)

    Time frame: following 15 weeks treatment

  13. Amount of Analgesics Used

    Time frame: 15 weeks treatment

  14. Number of Days With Incapability to Work

    Time frame: 15 weeks treatment

  15. Number of ADRs

    Time frame: within 15 weeks treatment

    frequency of ADR with a probable or possible causal relationship

Sponsors and collaborators

Lead sponsor

Pascoe Pharmazeutische Praeparate GmbH

Industry

Registry information

Official study title

Efficacy and Safety of Lymphdiaral Basistropfen (a Fixed Homoeopathic Remedy [HDC]) in the Treatment of Chronic Low-back Pain Considering Constitution and Diathesism: a Double Blind, Randomised, Placebo Controlled, Single-centre Study

Acronym: 144

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Jan 14, 2010
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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