osteoarthritis
Conditions
Interventions
Group 1 (study): 1 D-002 tablet (50 mg)by oral route at breakfast time during 6 weeks
Group 2 (control): 1 glucosamine/chondrointin sulphate tablet (750/250 mg) by oral route at breakfast time during
Sponsors
Center of Natural Products, National Center for Scientific Research
Dalmer Laboratories
Eligibility
Sex/Gender
All
Age
No minimum to 80 Years
Inclusion criteria
Inclusion criteria: 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
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 or active kidney disease. 6. Neoplasms diagnosed. 7. Severe high blood pressure 8. Uncompensated diabetes mellitus (fasting glucose> 7 mmol / L). 9. Hospitalization for any cause in the previous 6 months. 10. Subjects with normal clinical history of allergy to any other medicines or other special conditions that endanger their health and their lives during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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 Physical Activity Survey (WOMAC questionnaire. Value between 0 and 68 points). Measuring time: At baseline, and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Pain (visual scale by analogy. Value between 0-no pain-worst 100 points dolor bearable). Measuring time: At baseline, and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Biochemical Parameters (Cholesterol (mmol/L), Triglycerides (mmol/L), HDL-C (mmol/L) ), ALT (U/L), AST(U/L), Glucose (mmol/L), Creatinine (umol/L). Measuring time: At baseline and 6th weeks Physical Status (Weight (kg), Rate (beats/min), Blood pressure (mm Hg)). Measuring time: At baseline, and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Adverse events (description (AE name), Intensity (mild, moderate, severe), causality (definitely related, probably related, possibly related, unrelated)). Measuring time: At baseline, and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks | — |
Countries
Cuba
Contacts
Public ContactSarahi Mendoza Castaño
Center of Natural Productos, National Center for Scientific Research
Outcome results
None listed