NCT00317655已完成4 期
Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain - a Randomized, Double Blind, Placebo-Controlled Clinical Investigation With Parallel Groups for 3 Months to Enlighten Joint Health
Ferrosan AS2 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2006年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
mm pain relief (visual analog scale [VAS]) during past 24 hours compared from start (0 weeks) and 12 weeks
次要结局
- 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)
- Patients' Global Impression of Change (pain)
- Patients' satisfaction with pain medication
- Use of rescue medication
- Adverse events profile
- Body weight (start and 12 weeks)
研究者
研究点 (2)
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