Abexol and Glucosamine/Chondroitin Sulphate in osteoarthritis: study of the 6 months.

Study of the effects of Abexol (D-002) and the Glucosamine/Chondroitin Sulphate in subjects with symptoms of osteoarthritis: study of the 6 months. - Abe/Glu-02

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000222

Enrollment

Registered

2016-12-02

Start date

2017-01-15

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Osteoarthritis

Interventions

Group 1 (Experimental): An Abexol tablet (50 mg) by oral route at breakfast time during 6 months. Group 2 (Control): A Glucosamine/Chondrointin Sulphate tablet (375/300 mg) by oral route at breakfast

Tablets

Administration, Oral

Dietary Supplements

Glucosamine

Chondroitin Sulfates

Abexol, D-002, purified extract of beeswax

Eligibility

Sex/Gender

All

Age

20 Years 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 arterial hypertension 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 health status, 96-worst health status). Measuring Time: At baseline, at the end of the 6, 12, 18 and 24 weeks.	—

Secondary

Measure	Time frame
Pain (WOMAC questionnaire. Value between 0 and 20 points). Measuring time: At baseline, at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Stiffness (WOMAC questionnaire. Value between 0 and 8 points). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Physical Activity Survey (WOMAC questionnaire. Value between 0 and 68 points). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Pain (Visual Analogue Scale. Value between 0-no pain-100 points-Worst pain bearable). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Segurity and tolerability: Physical status (weight (kg), rate (beats/min), blood pressure (mm Hg)). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Biochemistry tests (laboratory values). Measuring time: At baseline, at the end of the 12 and 24 weeks. Adverse Events (description (AE name), intensity (mild, moderate, severe), causality relationship (definitely related, probably related, possibly related, unrelated)). Measuring time: At the end of the 6, 12, 18 and 24 weeks.	—

Measure

Time frame

Pain (WOMAC questionnaire. Value between 0 and 20 points). Measuring time: At baseline, at the end of the 1st, 2nd, 3rd, 4th, 5th and 6th weeks. Stiffness (WOMAC questionnaire. Value between 0 and 8 points). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Physical Activity Survey (WOMAC questionnaire. Value between 0 and 68 points). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Pain (Visual Analogue Scale. Value between 0-no pain-100 points-Worst pain bearable). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Segurity and tolerability: Physical status (weight (kg), rate (beats/min), blood pressure (mm Hg)). Measuring time: At baseline, at the end of the 6, 12, 18 and 24 weeks. Biochemistry tests (laboratory values). Measuring time: At baseline, at the end of the 12 and 24 weeks. Adverse Events (description (AE name), intensity (mild, moderate, severe), causality relationship (definitely related, probably related, possibly related, unrelated)). Measuring time: At the end of the 6, 12, 18 and 24 weeks.

—

Countries

Cuba

Contacts

Public ContactJulio Fernández Travieso

Center of Natural Products, National Center for Scientific Research

julio.fernandez@cnic.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026