Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis

Azidus

Status and phase: Completed; Phase 3

Conditions: Osteoarthrosis

Treatments: 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); Dietary Supplement: Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00860873

CGSEMS1108

Details and patient eligibility

About

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.

Enrollment: 280 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 4 patient groups

Test 1

Experimental group

Description:

Oral Powder EMS

Treatment:

Dietary Supplement: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)

Test 2

Experimental group

Description:

Hard Capsules EMS

Treatment:

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

Comparator 1

Active Comparator group

Description:

Oral Powder Zodiac

Treatment:

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

Comparator 2

Active Comparator group

Description:

Hard capsules - Zodiac

Treatment:

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