Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis

Phase 3

Completed

• Conditions: Osteoarthrosis
• Interventions: Dietary Supplement: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder); Dietary Supplement: EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules); Dietary Supplement: Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)

• Registration Number: NCT00860873
• Lead Sponsor: Azidus Brasil

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Study Start: 2009-10
• Primary Completion: 2009-11
• Study Completion: 2010-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test 1	EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)	Oral Powder EMS
Test 2	EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)	Hard Capsules EMS
Comparator 2	Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)	Hard capsules - Zodiac

Primary Outcome Measures

Name	Time	Method
Decrease in pain.	V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks).

Trial Locations

Locations (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda; 🇧🇷 Valinhos, Sao Paulo, Brazil