Contact information
Type
Scientific
Primary contact
Prof Andre-Michael Beer
ORCID ID
Contact details
Klinikum Blankenstein
Modellabteilung für Naturheilkunde
Im Vogelsang 5-11
Hattingen
D 45527
Germany
-
andre.beer@klinik-blankenstein.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01049373
Protocol/serial number
PSC 144/03
Study information
Scientific title
Efficacy and safety of lymphdiaral basistropfen (a homoeopathic remedy [HDC]) in the treatment of chronic low-back pain considering consitution and diathesism: a double blind, randomised, placebo controlled, single-centre study
Acronym
Study hypothesis
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.
Ethics approval
Bergmannsheil Bochum Ethikkommission, 23/07/2003
Study design
Interventional double-blind randomised placebo-controlled single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Low-back pain
Intervention
Intervention: lymphdiaral basistropfen, a homoeopathic remedy of 12 drugs, oral solution
Control: placebo oral solution
Each is to be taken 3 times daily, 10 drops in some liquid over 15 weeks.
Intervention type
Drug
Phase
Not Applicable
Drug names
Lymphdiaral basistropfen
Primary outcome measures
Change in FFbH-R following 15 weeks treatment
Secondary outcome measures
1. Change in FFbH-R following 2 weeks treatment
2. Change in pain score (SES) following 2 weeks treatment
3. Change in pain score (ES) following 15 weeks treatment
4. Change in strength of pain (Visual analog scale VAS) following 2 weeks treatment
5. Change in strength of pain (Visual analog scale VAS following 15 weeks treatment
6. Change in state of health (BF-S) following 2 weeks treatment
7. Change in state of health (BF-S) following 15 weeks treatment
8. Change in Oswestry Score following 2 weeks treatment
9. Change in Oswestry Score following 15 weeks treatment
10. Change in short form health survey 12 items (SF-12) following 2 weeks treatment
11. Change in short form health survey 12 items (SF-12) following 15 weeks treatment
12. Correlation of efficacy with the constitutional type of the patient, measured by the Hattinger Konstitutional Manual (HKM) and the Hattinger Konstitutional Questionnaire (HKF)
13. Amount of analgesics used
14. Number of days with incapability to work under 15 weeks treatment
15. Tolerability within 15 weeks treatment
Overall trial start date
05/12/2003
Overall trial end date
05/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female patients
2. Aged 18 - 75 years
3. Chronic low-back pain lasting at least for 6 months
4. Hanover functional ability questionnaire (FFbH-R) score less than 70%
5. At least one of the following diagnoses:
5.1. Chronic lumbar ischialgia with or withour radicular radiation
5.2. Chronic degenerative lumbar syndrome
5.3. Spondylarthrosis
5.4. Chronic facette syndrome
5.5. Lumbage with protrusion of the intervertebral disc
5.6. Lumbar radiculopathia
5.7. Lumbar and other intervertebral disc impairments with radiculopathia
5.8. Back pain at different locations of the spine
6. Written, informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140 (70 verum, 70 placebo)
Participant exclusion criteria
1. Participation in another clinical trial/GCP-trial within 30 days prior to screening
2. Participation in this trial in an earlier time
3. Treatment with lymphdiaral basistropfen within 3 month prior to enrolment
4. Pregnancy and lactation
5. Non-compliance
6. Incapability to understand the sense of the study
7. Abuse of analgesics, opiates or other drugs
8. 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
9. Malign diseases
10. Pathological neurological states
11. Epilepsy
12. Operation of the spine within 3 month prior to enrolment
13. Fractures of the spine
14. Bechterew's disease
15. Alcohol abuse
16. Consuming diseases
17. Cachexia
18. Palsy of the legs or anal sphincter due to acute impairment of the intervertebral disc
19. Catheterisation or CT-controlled intra-articular injection in the lumbar region
20. Hypersensitivity against one of the ingredients or excipients of the study drugs or against composite plants in general
21. Systemic, progressive diseases like tuberculosis, leucosis, collagenosis, multiple sclerosis, acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV) infection, or other auto-immune diseases
Recruitment start date
05/12/2003
Recruitment end date
05/05/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Klinikum Blankenstein
Hattingen
D 45527
Germany
Sponsor information
Organisation
PASCOE pharmazeutische Praeparate GmbH (Germany)
Sponsor details
Schiffenberger Weg 55
Giessen
D-35394
Germany
-
anja.braschoss@pascoe.de
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
PASCOE pharmazeutische Praeparate GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
See https://clinicaltrials.gov/ct2/show/results/NCT01049373
Publication summary