Efficacy and safety of lymphdiaral basistropfen in the treatment of chronic low-back pain

ISRCTN	ISRCTN88642122
DOI	https://doi.org/10.1186/ISRCTN88642122
ClinicalTrials.gov (NCT)	NCT01049373
Protocol serial number	PSC 144/03
Sponsor	PASCOE pharmazeutische Praeparate GmbH (Germany)
Funder	PASCOE pharmazeutische Praeparate GmbH (Germany)

Submission date: 18/05/2009
Registration date: 17/06/2009
Last edited: 16/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andre-Michael Beer
Scientific

Klinikum Blankenstein
Modellabteilung für Naturheilkunde
Im Vogelsang 5-11
Hattingen
D 45527
Germany

Email	andre.beer@klinik-blankenstein.de

Study information

Primary study design	Interventional
Study design	Interventional double-blind randomised placebo-controlled single-centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Bergmannsheil Bochum Ethikkommission, 23/07/2003
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Lymphdiaral basistropfen
Primary outcome measure(s)	Change in FFbH-R following 15 weeks treatment
Key secondary outcome measure(s)	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
Completion date	05/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	140
Total final enrolment	137
Key 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
Key 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
Date of first enrolment	05/12/2003
Date of final enrolment	05/05/2007

Locations

Countries of recruitment

Germany

Study participating centre

Klinikum Blankenstein

Hattingen
D 45527
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/06/2012	16/04/2019	Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/04/2019: Publication reference and total final enrolment added.