Low Back PainPhase 3144NCT01049373
Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain
A Phase 3 study testing HDC in people with Low Back Pain, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- HDC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2003to May 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Department of Naturopathy, Blankenstein Hospital
Hattingen, D-45527
About this study
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
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.
Read the 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
- Being tested
- HDC, Placebo solution
- Keywords
- low-back, pain, chronic, constitution, diathesism, homoeopathy, fixed combination, herbal preparation, chronic low back pain lasting more than 6 months
- Medical subject headings
- Low Back Pain, Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDCDrug
Also called Lymphdiaral Basistropfen
(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 solutionDrug
10 drops, t.i.d, 15 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: HDC |
| Placebo Solution | Placebo comparator | 10 drops t.i.d. for 15 weeks Receives: Drug: Placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: between screening and 15 weeks treatment
Secondary outcomes (15)
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)
Measured: 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)
Measured: 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)
Measured: following 15 weeks treatment
Change in Strength of Pain (Visual Analog Scale VAS)
Measured: following 2 weeks treatment
Change in Strength of Pain (Visual Analog Scale VAS)
Measured: following 15 weeks treatment
Change in State of Health (BF-S)
Measured: following 2 weeks treatment
Change in State of Health (BF-S)
Measured: following 15 weeks treatment
Change in Oswestry Score
Measured: following 2 weeks treatment
Change in Oswestry Score
Measured: following 15 weeks treatment
Change in Short Form Health Survey 12 Items (SF-12)
Measured: following 2 weeks treatment
Change in Short Form Health Survey 12 Items (SF-12) Ment
Measured: 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)
Measured: following 15 weeks treatment
Amount of Analgesics Used
Measured: 15 weeks treatment
Number of Days With Incapability to Work
Measured: 15 weeks treatment
Number of ADRs
frequency of ADR with a probable or possible causal relationship
Measured: within 15 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startDec 2003
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre M Beer, MD, PhD, Principal investigator, Department of True Naturopathy, Blankenstein Hospital; Im Vogelsang 5-11; D-45527 Hattingen; Germany;Juergen Kraemer, Prof, Study director, St. Josef Hospital. Gudrunstr. 56, 44791 Bochum, GermanyAnja Braschoss, MD, Study chair, Pascoe Pharmazeutische Praeparate GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049373
- Sponsor's protocol ID
- PSC144/03
- Other IDs
- ISRCTN88642122
- Acronym
- 144
- Status last verified
- Jun 2012
- First submitted
- 12 Jan 2010
- Last updated
- 6 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01049373
- Acronym / sponsor ID
- 144 / PSC144/03
- Conditions
- Low Back Pain
- Keywords
- low-back, pain, chronic, constitution, diathesism, homoeopathy, fixed combination, herbal preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Posted 6 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphdiaral Basistropfen (HDC) | Experimental | Drug: HDCHDC (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 | Drug: Placebo solution10 drops t.i.d. for 15 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDCAlso: Lymphdiaral Basistropfen(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. | Drug | Lymphdiaral Basistropfen (HDC) |
| Placebo solution10 drops, t.i.d, 15 weeks | Drug | Placebo Solution |
Primary outcome
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)
15 secondary outcomes
Change in FFbH-R Between Screening and 2 Weeks
Time frame: between screening and 2 weeks treatment
Change in Pain Score (SES), Subscale "Sensoric Pain"
Time frame: following 2 weeks treatment
Change in Pain Score (SES), Subscale "Sensoric Pain"
Time frame: following 15 weeks treatment
Change in Strength of Pain (Visual Analog Scale VAS)
Time frame: following 2 weeks treatment
Change in Strength of Pain (Visual Analog Scale VAS)
Time frame: following 15 weeks treatment
Change in State of Health (BF-S)
Time frame: following 2 weeks treatment
Change in State of Health (BF-S)
Time frame: following 15 weeks treatment
Change in Oswestry Score
Time frame: following 2 weeks treatment
Change in Oswestry Score
Time frame: following 15 weeks treatment
Change in Short Form Health Survey 12 Items (SF-12)
Time frame: following 2 weeks treatment
Change in Short Form Health Survey 12 Items (SF-12) Ment
Time frame: 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)
Time frame: following 15 weeks treatment
Amount of Analgesics Used
Time frame: 15 weeks treatment
Number of Days With Incapability to Work
Time frame: 15 weeks treatment
Number of ADRs
Time frame: within 15 weeks treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre M Beer, MD, PhD principal investigator
Department of True Naturopathy, Blankenstein Hospital; Im Vogelsang 5-11; D-45527 Hattingen; Germany;
Juergen Kraemer, Prof study director
St. Josef Hospital. Gudrunstr. 56, 44791 Bochum, Germany
Anja Braschoss, MD study chair
Pascoe Pharmazeutische Praeparate GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HDC in people with Low Back Pain, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FFbH-R Between Screening and Week 15 (time frame: between screening and 15 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.