Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Gin... | NCT00317655

Studies
Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain

NCT00317655

Sponsor

Ferrosan AS

Status

Completed

Last Update Posted

May 17, 2007Estimated

Enrollment

175Actual

Phase

Phase 4

Conditions

Back Pain

Interventions

Glucosamine sulphate
Ginger
Ginger-Avocado-Soya
Ginger-ibuprofen

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Eudractnr. 2005-002691-15

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Apr 23, 2006

First Submission Date that Met QC Criteria

Apr 23, 2006

First Posted Date

Apr 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2007

Last Update Posted Date

May 17, 2007Estimated

Description Module

Brief Summary

The main purpose of this study is to investigate the ability of some dietary supplement products to affect general joint health and life quality in a selected population with back pain.

The study is randomized and double - blind, with parallel groups receiving treatment for a duration of 12 weeks.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Measure	Description	Time Frame
mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic back pain daily or almost daily for at least 3 months prior to inclusion
Patient classified as I or II according to Quebec Task Force
No intake of glucosamine sulphate, ginger, or avocado-soya extract during last 3 months
Fertile women should, at start, have a negative pregnancy test and during test use acceptable prevention methods (p-pills, intrauterine device [IUD], depot gestagen, subdermal implant, hormonal vaginal ring or transdermal depot plaster).
Anxiolytics, muscle relaxants, physiotherapy, chiropractic treatment, or training should not have been used during last 3 months.

Exclusion Criteria:

Serious disease (eg. heart disease, cancer (within past 5 years), kidney disease, blood diseases, inflammatory diseases (eg. chronic rheumatoid arthritis, fibromyalgia)
Suspicion that back pain is caused by osteoporosis, other arthritic condition than osteoarthritis, cancer, infection, pain from organ disease or psychosomatic cancer disease.
Uncontrolled elevated blood pressure, defined as systolic ≥ 160 mm Hg or diastolic ≥ 90 mm Hg.
VAS measurement at inclusion less than ved 30 mm or over 90 mm.
Prehistory of ulcer, stomach surgery, or inflammatory bowel disease
Pain relief medication besides must not be taken during study.
Patients in need of non-steroidal anti-inflammatory drugs (NSAIDs), morphine, or similar medication are not eligible. Same is also valid for patients in need of injections or acupuncture.
Back surgery within 6 months before inclusion or earlier surgery without effect
"Heart" aspirin (low dose), ulcer medication, or blood thinning medication
Alcohol abuse
Depression
Pregnancy or breastfeeding
Allergy to crustaceans or known intolerance for glucosamine sulphate, ginger, avocado, soy, or ibuprofen
Allergy or asthma released by salicylic acid or other arthritis medication (NSAIDs)
Patient who is seeking pension due to back pain or has other economical interests connected to his/her back pain

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Glucosamine sulphate	Drug
Ginger	Drug
Ginger-Avocado-Soya	Drug
Ginger-ibuprofen	Drug

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D005944	Glucosamine
C000713927	ginger extract

ID	Term
D006595	Hexosamines
D000606	Amino Sugars
D002241	Carbohydrates

Measure	Description	Time Frame
Percentage of responders showing more than 15 mm improvement in pain relief
mm pain relief (VAS) within past 7 days at weeks 1, 2, 4, 6, 9, and 12
Function level according to Roland Morris-questionnaire (23 points)