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OpenTrials
Completed

NCT Number: NCT00860873

Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)

Dietary Supplement

Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg

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

Dietary Supplement

Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg

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

Dietary Supplement

Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg

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

Dietary Supplement

Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg

Primary outcomes

  1. Decrease in pain.

    Time frame: V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks).

Sponsors and collaborators

Lead sponsor

Azidus Brasil

Industry

Registry information

Official study title

Randomized Study of Two Dosage Forms (Oral Powder and Capsule) of "Chondroitin + Glucosamine Sulfate" Produced by the Laboratory EMS When Compared to the Product Condroflex (Oral Powder and Capsules) Produced by Laboratory Zodiac in the Treatment of Osteoarthrosis.

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Mar 12, 2009
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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