Prevenox on osteoarthritis

Phase 4

• Conditions: Osteoarthritis symptoms

• Registration Number: RPCEC00000170
• Lead Sponsor: Center of Natural Products, Nacional Center for Scientific Researchs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Subjects of both sexes
2. aged between 20 and 80 years
3. Subjects with symptoms of OA (joint pain in hip, spine, limbs and / or phalanges)
4. Subjects who signed the informed consent.
5. Subjects who qualified in Scales I-III of the American Association of Rheumatology
6. Subjects who had a WOMAC scale score = 30.

Exclusion Criteria

1. Existence of other forms of arthritis,
2. Arthroplasty or orthopedic surgery in the last three years
3. Transplanted
4. Subjects with active liver or kidney disease
5. Neoplasms diagnosed,
6. Severe hypertension
7. Diabetes mellitus uncompensated
8. Hospitalization for any cause in the previous 6 months,
9. Subjects with fasting glucose> 7 mmol / L
10. Subjects with usual clinical history of allergy to drugs
11. Subjects with any other special condition that jeopardize their health and their lives during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Status (WOMAC Questionnaire. 0-Best Score between health status and 96-worst health status). Measuring Time: Before starting treatment and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks

Secondary Outcome Measures

Name	Time	Method
Pain (WOMAC Questionnaire. Value between 0 and 20 points). Measuring time: at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks<br><br>Stiffness (WOMAC Questionnaire. Value from 0 to 8 points). Measuring time:at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks<br><br>Physical Activity Questionnaire(WOMAC. Value between 0 and 68 points). Measuring time: at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks<br><br>Pain (Visual Analogy Scale- VAS-. Value between 0-no pain-worst 100 points bearable pain). Measuring time:at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks<br><br>Adverse events (description (name of the event), intensity (mild-moderate, severe), causality (definitely related, probably related, possibly related, not related)). Measuring time: At the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks.