Osteoarthritis of the Knee Joint
Conditions
Interventions
The inverse methylation intervention group:Take supplements that could inverse methylation
Control group:A placebo identical in appearance, color, taste, and packaging to the anti-aging supplement.
Sponsors
The Fourth Medical Center of the Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients aged 40 years or older and diagnosed with primary osteoarthritis; 2.Radiologically staged as stage II or III osteoarthritis (according to the Kellgren and Lawrence criteria); 3.Frequent occurrence of knee pain on multiple days within one month before the trial; 4.Not participating in other clinical trials; 5.No clinical or significant laboratory abnormalities (judged by the researcher); 6.Patients who consent to participate in all follow-ups related to the trial.
Exclusion criteria
Exclusion criteria: 1.Patients with mental disorders or cognitive deficits who are unable to cooperate with the study; 2.Patients with active malignant tumors or a history of malignant tumors within the past 5 years; 3.Patients with pain in other parts that may affect the evaluation of the curative effect on joint pain (such as chondrocalcinosis, Paget's disease of the ipsilateral target knee joint, rheumatoid arthritis, aseptic osteonecrosis, gout, suppurative arthritis, alkaptonuria, acromegaly, hemochromatosis, Wilson's disease, osteochondroma, seronegative spondyloarthropathy, mixed connective tissue disease, connective tissue disease, psoriasis, inflammatory bowel disease, etc.); 4.Patients with a history of undergoing arthroscopic surgery on the affected joint within 6 months before enrollment in the study; 5.Subjects who have undergone total knee arthroplasty on the contralateral knee joint within 6 months before the study screening visit and throughout the study; 6.Subjects who plan to undergo surgery during the trial; 7.Patients with a history of heart attack or stroke, or with chest pain related to heart disease, or suffering from severe heart diseases (such as congestive heart failure, New York Heart Association cardiac function class II-IV); 8.Subjects at high risk of cardiovascular events; 9.Patients with any major diseases or conditions, including emotional or mental disorders or drug abuse, which in the opinion of the researcher may alter the course of osteoarthritis or affect the subject's ability to complete the study; 10.Patients with poorly controlled diabetes mellitus whose hemoglobin A1c level is > 8%; 11.Patients with poorly controlled hypertension whose systolic blood pressure is persistently > 150 mmHg or diastolic blood pressure is > 95 mmHg; 12.Subjects with any active acute or chronic infections requiring antimicrobial treatment, or subjects with severe viral (such as hepatitis, herpes zoster, HIV-positive) or fungal infections; 13.Subjects who were diagnosed with or received treatment for esophageal, gastric, pyloric canal or duodenal ulcers within 30 days before the first administration of the study drug; 14.Female subjects who are breastfeeding; 15.Severe comorbidities, such as active infections, malignant tumors, end-stage renal disease (eGFR < 15 mL/min) or uncontrolled cardiovascular diseases (such as New York Heart Association cardiac function class III-IV); 16.Long-term use of anticoagulants (such as warfarin), NMDA receptor antagonists (such as ketamine) or other drugs that may affect epigenetics (such as DNA methyltransferase inhibitors); 17.Contraindications for testing, contraindications for joint fluid collection (such as coagulation disorders, infection at the puncture site).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC osteoarthritis index;Systemic epigenetic age;Kellgren-Lawrence (KL) score;Total Bilirubin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose;Blood lipid;Alanine transaminase (ALT);Aspartate transaminase(AST);Alkaline phosphatase (ALP);Blood urea nitrogen (BUN);Serum creatinine;Uric acid;Health Behavior Assessment Questionnaire, HBAQ;Physical Activity Behavior Assessment Questionnaire;Total Protein;Albumin; | — |
Countries
China
Contacts
Public ContactNan Shaokui
The Fourth Medical Center of the Chinese People's Liberation Army General Hospital
Outcome results
None listed