Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis

NCT ID: NCT00860873

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-11-30

Brief Summary

This study objective is to check the non-inferiority of the 2 formulations produced by EMS when compared with the same substances and pharmaceuticals forms of the product Condroflex (Zodiac), by promoting the relief of osteoarthrosis symptoms such as pain, stiffness and functional capacity that will be periodically measured by using the "Visual Analog Scale" of pain (VAS) and the questionnaire of Lequesne.

Conditions

Osteoarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test 1

Oral Powder EMS

Group Type: EXPERIMENTAL

EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)

Intervention Type: DIETARY_SUPPLEMENT

Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg

Test 2

Hard Capsules EMS

Group Type: EXPERIMENTAL

EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)

Intervention Type: DIETARY_SUPPLEMENT

Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg

Comparator 1

Oral Powder Zodiac

Group Type: ACTIVE_COMPARATOR

Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)

Intervention Type: DIETARY_SUPPLEMENT

Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg

Comparator 2

Hard capsules - Zodiac

Group Type: ACTIVE_COMPARATOR

Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)

Intervention Type: DIETARY_SUPPLEMENT

Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg

Interventions

EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)

Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg

Intervention Type: DIETARY_SUPPLEMENT

EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)

Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg

Intervention Type: DIETARY_SUPPLEMENT

Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)

Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg

Intervention Type: DIETARY_SUPPLEMENT

Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)

Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Patients who agree with all aspects of the study and sign the Informed Consent;
• Patients of both sexes;
• Age above 30 years;
• Clinical and radiological diagnosis of osteoarthritis;
• Osteoarthritis in grades 1-2;
• Patients who are conducting medical treatment and that, for trial of Investigator, is eligible for the study.

Exclusion Criteria

• Patients with a history of trauma clinically significant;
• Patients who underwent surgery on joints affected;
• Coexistence of diseases that might impede the successful conclusion of the trial (rheumatism and others);
• Pregnant patients and / or breastfeeding;
• Patients with phenylketonuria;
• Patients with clinical diagnosis of severe renal failure;
• Patients with clinical diagnosis of severe liver disease;
• Patients with clinical diagnosis of clotting disorders;
• Patients who are being treated with anti-aggregating and / or anticoagulants;
• Patients with sensitive components of the formula;
• Patients with emotional disorders that interfere with the capture of data;
• Patients who do not agree with the purposes of the study and did not sign the Informed Consent.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

LAL Clinica

Locations

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CGSEMS1108

Identifier Type: -

Identifier Source: org_study_id