Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage

Osteoarthritis Clinical Trial

— msm  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01836757
• Other study ID #: msm2012
• Status: Recruiting
• Phase: Phase 1
• First received: March 13, 2013
• Last updated: April 17, 2013
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: April 2013
• Source: G.Papanikolaou Research Group
• Contact: Thomas Pagonis, MD, PhD
• Phone: 00306980488686
• Email: iatros1[@]yahoo.com
• Is FDA regulated: No
• Health authority: Greece: National Drug OrganizationGreece: Ellinikos Organismos Farmakon EOF
• Study type: Interventional

Clinical Trial Summary

To delineate the effect of MSM on osteoarthritis

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Knee and hip OA

• men and women >45 years of age

Exclusion Criteria:

• 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

• cancer

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• MethylSulfonylMethane (MSM)
Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)
• Placebo

Locations

Country	Name	City	State
Greece	G. Papanikolaou Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
G.Papanikolaou Research Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with improved Mobility	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)	26 weeks	Yes
Secondary	Pain Scores on the Visual Analog Scale	On the same two groups (MSM and Placebo)we measured the improvement of quality of life through pain relief as measured by use of SF-36 (overall health-related quality of life)	26 weeks	Yes