Ginger, ginger-avokado-soy, glucosamine sulfate and ginger-ibuprofen in relation to chronic low back pain - a randomised double-blind, placebo-controlled clinical trial with parallel groups for 3 months to illustrate jointhealth.

• Conditions: Chronic low back pain

• Registration Number: EUCTR2005-002691-15-DK
• Lead Sponsor: Ferrosan A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Subject is able and willing to give written informed consent.
Subject is able to read, comprehend and record information required in the protocol.
Chronic low back pain is defined as pain every day or nearly every day for ?3 months up to inclusion. The low back is defined as the area of the back bounded by the lowest rib and the crease of the but-tocks. The pain should be classified as Quebec Task Force Class I (pain without radiation to an ex-tremity and without neurologic signs) or Class II (pain with radiation to an extremity but not below the knee and without neurologic signs).
Subject is male or female, 30 years or more of age.
A fertile female is eligible to participate in the study if she is has a negative pregnancy test at inclusion and agrees to use one of the acceptable methods of contraception during the study.
No intake of glucosamine sulphate, ginger or ginger/avocado/soy within the last 3 months.
Calming and muscle relaxing medicine that has been used in a period of minimum 3 months before inclusion can be used during the trial. The same applies to treatment as physiotherapy, chiropractic treatment and training.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Serious illness e.g. cardiovascular disease, cancer diseases, kidney diseases, blood diseases and inflammation diseases.
Uncontrolled hypertension.
VAS measurement at inclusion of less than 30 mm or above 90 mm.
Gastrointestinal ulceration or history of any gastric or duodenal surgery.
Pain relieving medicine besides paracetamol cannot be used in the study. Patients in need of NSAID, morphine or morphine-like medication cannot participate. The same applies to patients in need of in-jections ore acupuncture.
Subject has had surgery for low back pain within 6 months of inclusion or has had failed back surgery.
Use of anticoagulants or anti-platelet aggregation agents.
Alcohol abuse.
Depression
Pregnant or lactating
Shellfish allergy or known allergy/intolerance towards glucosamine sulphate, ginger, avocado, soy or ibuprofen.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the clinical efficacy of ginger, ginger/avokado/soy, glucosamine sulphate and gin-ger/ibuprofen in adults with chronic low back pain;Secondary Objective: ;Primary end point(s): Pain relief based on VAS (visual analog scale) between inclusion and end-visit for each of the 4 intervention groups (ginger, ginger/avocado/soy, glucosamine sulphate and ginger/ibuprofen) compared to placebo.