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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN88642122 | Registry Identifier | ISRCTN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lymphdiaral Basistropfen (HDC) | Experimental | 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. |
|
| Placebo Solution | Placebo Comparator | 10 drops t.i.d. for 15 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | between screening and 15 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
Written, informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre M Beer, MD, PhD | Department of True Naturopathy, Blankenstein Hospital; Im Vogelsang 5-11; D-45527 Hattingen; Germany; | Principal Investigator |
| Juergen Kraemer, Prof | St. Josef Hospital. Gudrunstr. 56, 44791 Bochum, Germany | Study Director |
| Anja Braschoss, MD | Pascoe Pharmazeutische Praeparate GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Naturopathy, Blankenstein Hospital | Hattingen | D-45527 | Germany |
screening visit (up to one week before baseline)
hospital, 5.12.2003 - 5.5.2007 (first patient in / last patient out)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo Solution | 10 drops t.i.d. for 15 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | ITT | Posted | Mean | Standard Deviation | units on a scale | between screening and 15 weeks treatment |
|
from 2003-Dec-05 to 2007-May-05
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Athroscopy | Investigations | MedDRA (10.1) | Systematic Assessment | unlikely |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gabriele Weiss | PASCOE pharmazeutische Präparate GmbH | 0049/641/7960-0 | klinischeforschung@pascoe.de |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| Placebo solution | Drug | 10 drops, t.i.d, 15 weeks |
|
| between screening and 2 weeks treatment |
| 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) | following 2 weeks treatment |
| 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) | following 15 weeks treatment |
| Change in Strength of Pain (Visual Analog Scale VAS) | following 2 weeks treatment |
| Change in Strength of Pain (Visual Analog Scale VAS) | following 15 weeks treatment |
| Change in State of Health (BF-S) | following 2 weeks treatment |
| Change in State of Health (BF-S) | following 15 weeks treatment |
| Change in Oswestry Score | following 2 weeks treatment |
| Change in Oswestry Score | following 15 weeks treatment |
| Change in Short Form Health Survey 12 Items (SF-12) | following 2 weeks treatment |
| Change in Short Form Health Survey 12 Items (SF-12) Ment | following 15 weeks treat |
| Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF) | following 15 weeks treatment |
| Amount of Analgesics Used | 15 weeks treatment |
| Number of Days With Incapability to Work | 15 weeks treatment |
| Number of ADRs | frequency of ADR with a probable or possible causal relationship | within 15 weeks treatment |
| Adverse Event |
|
| Lost to Follow-up |
|
| no evaluable study values |
|
| Other |
|
| Non-cooperation |
|
| BG001 |
| Placebo Solution |
10 drops t.i.d. for 15 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo Solution | 10 drops t.i.d. for 15 weeks |
|
|
|
| Secondary | 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) | ITT | Posted | Mean | Standard Deviation | units on a scale | between screening and 2 weeks treatment |
|
|
|
|
| Secondary | 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) | Only patients with assessable values at present time point were analyzed. | Posted | Mean | Standard Deviation | units on a scale | following 2 weeks treatment |
|
|
|
|
| Secondary | 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) | Only patients with assessable values at present time point were analyzed. | Posted | Mean | Standard Deviation | units on a scale | following 15 weeks treatment |
|
|
|
|
| Secondary | Change in Strength of Pain (Visual Analog Scale VAS) | Not Posted | following 2 weeks treatment |
| Secondary | Change in Strength of Pain (Visual Analog Scale VAS) | Not Posted | following 15 weeks treatment |
| Secondary | Change in State of Health (BF-S) | Not Posted | following 2 weeks treatment |
| Secondary | Change in State of Health (BF-S) | Not Posted | following 15 weeks treatment |
| Secondary | Change in Oswestry Score | Not Posted | following 2 weeks treatment |
| Secondary | Change in Oswestry Score | Not Posted | following 15 weeks treatment |
| Secondary | Change in Short Form Health Survey 12 Items (SF-12) | Not Posted | following 2 weeks treatment |
| Secondary | Change in Short Form Health Survey 12 Items (SF-12) Ment | Not Posted | following 15 weeks treat |
| Secondary | Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF) | Not Posted | following 15 weeks treatment |
| Secondary | Amount of Analgesics Used | Not Posted | 15 weeks treatment |
| Secondary | Number of Days With Incapability to Work | Not Posted | 15 weeks treatment |
| Secondary | Number of ADRs | frequency of ADR with a probable or possible causal relationship | Posted | Number | adverse reactions | within 15 weeks treatment |
|
|
|
| 6 |
| 112 |
| 43 |
| 112 |
| EG001 | Placebo Solution | 10 drops t.i.d. for 15 weeks | 7 | 109 | 39 | 109 |
| Depression | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment | not related |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment | not related |
|
| Mental disoerder due to a general medical condition | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment | not related |
|
| Hypertensive crisis | Vascular disorders | MedDRA (10.1) | Systematic Assessment | not related |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment | possible |
|
| Musculosskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment | not related |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment | not related |
|
| Knee operation | Surgical and medical procedures | MedDRA (10.1) | Systematic Assessment | not related |
|
| Intestinal operation | Surgical and medical procedures | MedDRA (10.1) | Systematic Assessment | not related |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA (10.1) | Systematic Assessment | not related |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
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| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |