Bioactive formulation to treat osteoarthritis

Phase 1

• Conditions: Osteoarthritis of the shoulder; Osteoarthritis of the knee, hip, shoulder, or jaw joints; Osteoarthritis of the Jaw; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Osteoarthritis, Hip; Osteoarthritis, Knee

• Registration Number: RPCEC00000250
• Lead Sponsor: Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-15
• Results First Posted: 2018-10-24
• Study Completion: 2024-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients older than 18 years.
2. Patients with clinical and radiographic diagnosis of osteoarthritis in the hip, knee, shoulder or mandible.
3. Patients with severe structural damage to their joint.
4. Severe and unproven articular symptomatology to conservative treatment and candidates for total joint arthroplasty (joint prosthesis placement).
5. Signature written informed consent of the patient

Exclusion Criteria

1. Rheumatoid arthritis
2. Autoimmune diseases
3. Decompensated systemic disease
4. Creatinine 1.25 times the normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method).
5. Blood leucocytes less than 3000 cells / microliter or platelet count less than 100,000 / microliter.
6. Blood hemoglobin less than 10 g / deciliter.
7. Increase in the last month of diastolic blood pressure to 110 mmHg or more and / or onset of hematuria or proteinuria greater than 300 milligrams / day.
9. Pregnancy or women of childbearing potential without contraceptive method: salpingoclasia, device or hormonal. Breastfeeding women.
10. Alcoholism and / or drug addiction.
11. Known liver disease with twice the increase in liver function tests (Aspartate amino transferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin).
12. Presence of: Cancer
13. Other pathologies at the discretion of the researcher

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE) version 3). Measurement time: baseline, 3, 30, 60, 180 and 360 days.<br>Therapeutic efficacy (improvement in quality of life index. Interrogation on joint pain intensity and quality of life; WOMAC, RAPID3 and RASMUSSEN Clinical score). Measurement time: baseline, at 3, 30, 60, 180 and 360 days.

Secondary Outcome Measures

Name	Time	Method
Full joint improvement: Thickness of articular cartilage by (Magnetic Resonance Imaging analysis of treated joint to assess variations in thickness of articular cartilage). Measurement time: baseline and 12 months.<br>