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临床试验/NCT01836757
NCT01836757Unknown1 期

The Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Joint Cartilage Associated With the Degeneration of the Chondrocyte

G.Papanikolaou Research Group1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
100
试验地点
1
主要终点
Number of participants with improved Mobility

研究概览

简要总结

To delineate the effect of MSM on osteoarthritis

详细描述

Objective

To delineate the effect of MSM on osteoarthritis of large joints. Design: Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA to be divided in 2 groups. Intervention is either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured are the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC), patient and physician assessments and SF-36 (overall health-related quality of life).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Knee and hip OA
  • men and women >45 years of age

排除标准

  • any other type of arthritis
  • chronic pain syndrome
  • arthroscopic surgery in the past 8 months
  • intra-articular corticosteroidsin the past 8 months
  • hyaluronic acid injections in the past 8 months
  • narcotic pain killers use
  • renal or hepatic disease
  • body mass index (BMI) >45 kg/m2

研究组 & 干预措施

MSM group

Experimental

Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)

干预措施: MethylSulfonylMethane (MSM) (Drug)

Placebo Group

Placebo Comparator

Placebo 3 gr twice a day for 26 weeks (6 gr/day total)

干预措施: Placebo (Drug)

结局指标

主要结局

Number of participants with improved Mobility

时间窗: 26 weeks

Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA were divided in 2 groups. Intervention was either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured were the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC)

次要结局

  • Pain Scores on the Visual Analog Scale(26 weeks)

研究者

发起方
G.Papanikolaou Research Group
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Pagonis

Orthopaedic Surgeon

G.Papanikolaou Research Group

研究点 (1)

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