D002/Lyprinol for osteoarthritis

Phase 4

Conditions: Osteoarthritis symptoms

Registration Number: RPCEC00000166

Lead Sponsor: Center of Natural Products, National Center for Scientific Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 50

Inclusion Criteria

The sample will be made ??up of:
1. Women and men
2. Ages between 20 and 80 years
3. With symptoms of OA (joint pain in hip, spine, limbs and / or phalanges)
4. Which have agreed to give informed consent.
5. Patients classified in Scales I-III of the American Association of Rheumatology
6. Patients with WOMAC score = 25

Exclusion Criteria

1. Existence of other forms of arthritis.
2. Arthroplasty in the last 3 years.
3. Any orthopedic surgery in the last 3 years.
4. Transplanted.
5. Active liver disease.
6. Active kidney disease.
7. Neoplasms diagnosed.
8. Severe high blood pressure
9. Uncompensated diabetes mellitus (fasting glucose> 7 mmol / L).
10. Hospitalization for any cause in the previous 6 months.
11. Subjects with normal clinical history of allergy to any other medicines
12. Subjects with other special conditions that endanger 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<br>

Secondary Outcome Measures

Name	Time	Method
Pain (WOMAC questionnaire. Value between 0 and 20 points). Measuring time: Before starting treatment 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: Before starting treatment and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks<br><br>Physical Activity Survey (WOMAC questionnaire. Value between 0 and 68 points). Measuring time: Before starting treatment and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks<br><br>Pain (visual scale by analogy. Value between 0-no pain-worst 100 points dolo bearable). Measuring time: Before starting treatment and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks