Osteoarthritis
Conditions
Interventions
Control group:Oral placebo capsules(1 capsule, (t.i.d.)) and Glucosamine Hydrochloride capsules (1 capsule, (b.i.d.)), for 3months.
Experimental group:Oral Vitamin B7 capsules (1 capsule, (t.i.d.)) and Glucosamine Hydrochloride capsules (1 capsule, (b.i.d.)), for 3months.
Sponsors
Guangdong Provincial Key Laboratory of Bone and Joint Degeneration Diseases, Department of Cell Biology, School of Basic Medical Sciences, Southern Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 40 years and <= 80 years; 2. Meet the American College of Rheumatology diagnostic criteria for symptomatic KOA; 3. Kellgren–Lawrence radiographic grade 1 or 2 in the affected knee(s); 4. Average knee pain over the past week =20 mm on the visual analog scale (VAS); 5. Able and willing to tolerate plain radiography; 6. Willing to undergo magnetic resonance imaging (MRI) examination; 7. Voluntary participation with the ability to provide written informed consent; 8. Able to accept telephone follow-up or return visits to the hospital.
Exclusion criteria
Exclusion criteria: 1. Patients with acute pain flare of KOA, which is usually accompanied with joint swelling and high local skin temperature; 2. Pregnant women, women with a positive pregnancy test, or nursing mothers; 3. Rheumatoid arthritis or other autoimmune diseases, or any severe systemic illness such as psoriatic arthritis, lupus, active malignancy, or severe cardiovascular or renal disease; 4. Use of intra-articular, intramuscular, or oral corticosteroids or sodium hyaluronate within the past 3 months; 5. History of allergy to any component of the study medication; 6. Active liver disease is defined as alanine transaminase or aspartate transaminase >1.5 × the upper limit of normal; 7. Renal impairment defined as serum creatinine >133 µmol/L; 8. Contraindications to MRI, such as cardiac pacemaker, prosthetic metallic valve, cerebral aneurysm clip, arterial dissection, or claustrophobia; 9. Concurrent participation in another clinical trial that may influence the results of this study; 10. Deemed unsuitable for the study by the investigator; 11. Abnormal thyroid function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario McMaster Osteoarthritis Index (WOMAC) pain score ;radiological changes in cartilage thickness ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual analog scale;WOMAC function and stiffness score;Tibiofemoral cartilage defect;Adverse reaction; | — |
Countries
China
Contacts
Public ContactBai Xiaochun
Guangdong Provincial Key Laboratory of Bone and Joint Degeneration Diseases, Department of Cell Biology, School of Basic Medical Sciences, Southern Medical University
Outcome results
None listed