Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain

NCT01049373 | Completed Phase 3 Results

• 2 other identifiers: PSC144/03ISRCTN88642122
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Keywords

low-back; pain; chronic; constitution; diathesism; homoeopathy; fixed combination; herbal preparation; chronic low back pain lasting more than 6 months

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• Change in FFbH-R Between Screening and 2 Weeks

  between screening and 2 weeks treatment

• Change in Pain Score (SES), Subscale "Sensoric Pain"

  following 2 weeks treatment

• Change in Pain Score (SES), Subscale "Sensoric Pain"

  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

Study Arms (2)

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.

Drug: HDC

Placebo Solution

PLACEBO COMPARATOR

10 drops t.i.d. for 15 weeks

Drug: Placebo solution

Interventions

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.

Also known as: Lymphdiaral Basistropfen

Lymphdiaral Basistropfen (HDC)

Placebo solution DRUG

10 drops, t.i.d, 15 weeks

Placebo Solution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead

Study Sites (1)

Department of Naturopathy, Blankenstein Hospital

Hattingen, D-45527, Germany

Location

MeSH Terms

Conditions

Low Back Pain; Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Dr. Gabriele Weiss
• Organization: PASCOE pharmazeutische Präparate GmbH

klinischeforschung@pascoe.de

0049/641/7960-0

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Study Start: December 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: September 6, 2012
• Results First Posted: September 6, 2012

Record last verified: 2012-06

Locations

DE (1)