Condition category
Musculoskeletal Diseases
Date applied
18/05/2009
Date assigned
17/06/2009
Last edited
23/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.pascoe-global.com

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

Publication citations

Additional files

Editorial Notes