Abexol + Prevenox in Osteoarthritis

Effects of the administration of Abexol (D-002) and Prevenox (D-003) in subjects with osteoarthritis symptoms

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000171

Enrollment

120

Registered

2013-09-20

Start date

2012-12-04

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Interventions

Control Group. 1 Placebo tablet of Abexol + 2 Placebo Tablets of Prevenox, by oral route, at breakfast for 6 weeks Study Group 1. 1 tablet of Abexol (50 mg) + 2 Placebo Tablets of Prevenox, by oral r

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion criteria

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

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 or kidney diseases. 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. 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.

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 an 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, 100-worst pain imaginable). Measuring time:at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Physical exam (Weigth (kg), Blood presure (mm Hg), Cardiac frequency (Pulse por minute)). Measuring time: at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Blood biochemical parameters (alanine amino transferase (ALT) (U / L), aspartate aminotransferase (AST) (U / L), glucose (mmol / L), creatinine (umol / L), total cholesterol (mmol / L) , Triglycerides (mmol / L)). Measuring time: at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Adverse Events (AE). Description of the AE (name of the event) Intensity of AE(Mild, Moderate, Severe) Relationship (WHO scale- Very probable, Probable, Possible, Remote, Not related, Unknown). Measuring time: At the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks.	—

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 an 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, 100-worst pain imaginable). Measuring time:at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks Physical exam (Weigth (kg), Blood presure (mm Hg), Cardiac frequency (Pulse por minute)). Measuring time: at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Blood biochemical parameters (alanine amino transferase (ALT) (U / L), aspartate aminotransferase (AST) (U / L), glucose (mmol / L), creatinine (umol / L), total cholesterol (mmol / L) , Triglycerides (mmol / L)). Measuring time: at baseline and at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Adverse Events (AE). Description of the AE (name of the event) Intensity of AE(Mild, Moderate, Severe) Relationship (WHO scale- Very probable, Probable, Possible, Remote, Not related, Unknown). Measuring time: At the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks.

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Countries

Cuba

Contacts

Public ContactSarahi Mendoza Castaño

Center of Natural Products/National Center for Scientific Research

sarahi.mendoza@cnic.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026