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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
HDC
Placebo solution
Sponsored by
Pascoe Pharmazeutische Praeparate GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low-back, pain, chronic, constitution, diathesism, homoeopathy, fixed combination, herbal preparation, chronic low back pain lasting more than 6 months

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Naturopathy, Blankenstein Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lymphdiaral Basistropfen (HDC)

Placebo Solution

Arm 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.

10 drops t.i.d. for 15 weeks

Outcomes

Primary Outcome Measures

Change in FFbH-R Between Screening and Week 15
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 Outcome Measures

Change in FFbH-R Between Screening and 2 Weeks
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)
Change in Pain Score (SES), Subscale "Sensoric Pain"
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)
Change in Pain Score (SES), Subscale "Sensoric Pain"
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)
Change in Strength of Pain (Visual Analog Scale VAS)
Change in Strength of Pain (Visual Analog Scale VAS)
Change in State of Health (BF-S)
Change in State of Health (BF-S)
Change in Oswestry Score
Change in Oswestry Score
Change in Short Form Health Survey 12 Items (SF-12)
Change in Short Form Health Survey 12 Items (SF-12) Ment
Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)
Amount of Analgesics Used
Number of Days With Incapability to Work
Number of ADRs
frequency of ADR with a probable or possible causal relationship

Full Information

First Posted
January 12, 2010
Last Updated
August 3, 2012
Sponsor
Pascoe Pharmazeutische Praeparate GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01049373
Brief Title
Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain
Acronym
144
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pascoe Pharmazeutische Praeparate GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low-back, pain, chronic, constitution, diathesism, homoeopathy, fixed combination, herbal preparation, chronic low back pain lasting more than 6 months

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lymphdiaral Basistropfen (HDC)
Arm Type
Experimental
Arm 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.
Arm Title
Placebo Solution
Arm Type
Placebo Comparator
Arm Description
10 drops t.i.d. for 15 weeks
Intervention Type
Drug
Intervention Name(s)
HDC
Other Intervention Name(s)
Lymphdiaral Basistropfen
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.
Intervention Type
Drug
Intervention Name(s)
Placebo solution
Intervention Description
10 drops, t.i.d, 15 weeks
Primary Outcome Measure Information:
Title
Change in FFbH-R Between Screening and Week 15
Description
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)
Time Frame
between screening and 15 weeks treatment
Secondary Outcome Measure Information:
Title
Change in FFbH-R Between Screening and 2 Weeks
Description
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)
Time Frame
between screening and 2 weeks treatment
Title
Change in Pain Score (SES), Subscale "Sensoric Pain"
Description
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)
Time Frame
following 2 weeks treatment
Title
Change in Pain Score (SES), Subscale "Sensoric Pain"
Description
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)
Time Frame
following 15 weeks treatment
Title
Change in Strength of Pain (Visual Analog Scale VAS)
Time Frame
following 2 weeks treatment
Title
Change in Strength of Pain (Visual Analog Scale VAS)
Time Frame
following 15 weeks treatment
Title
Change in State of Health (BF-S)
Time Frame
following 2 weeks treatment
Title
Change in State of Health (BF-S)
Time Frame
following 15 weeks treatment
Title
Change in Oswestry Score
Time Frame
following 2 weeks treatment
Title
Change in Oswestry Score
Time Frame
following 15 weeks treatment
Title
Change in Short Form Health Survey 12 Items (SF-12)
Time Frame
following 2 weeks treatment
Title
Change in Short Form Health Survey 12 Items (SF-12) Ment
Time Frame
following 15 weeks treat
Title
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
Title
Amount of Analgesics Used
Time Frame
15 weeks treatment
Title
Number of Days With Incapability to Work
Time Frame
15 weeks treatment
Title
Number of ADRs
Description
frequency of ADR with a probable or possible causal relationship
Time Frame
within 15 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre M Beer, MD, PhD
Organizational Affiliation
Department of True Naturopathy, Blankenstein Hospital; Im Vogelsang 5-11; D-45527 Hattingen; Germany;
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juergen Kraemer, Prof
Organizational Affiliation
St. Josef Hospital. Gudrunstr. 56, 44791 Bochum, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anja Braschoss, MD
Organizational Affiliation
Pascoe Pharmazeutische Praeparate GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Naturopathy, Blankenstein Hospital
City
Hattingen
ZIP/Postal Code
D-45527
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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