Hip Osteoarthritis
Conditions
Interventions
Experimental group:Oral celecoxib capsule and tonifying Kidney and Activating Blood Decoction
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the HOA medicine diagnostic criteria and have a Traditional Chinese Medicine syndrome of liver and kidney deficiency; 2. Target hip joint X-ray Kellgren-Lawrence radiological grading (K-L grade IV) is I-III; 3. Age = 40 years and = 75 years regardless of gender; 4. Male weight = 50 kg female weight = 45 kg; 5. Patients using analgesic therapy (taking paracetamol/acetaminophen) to control local pain in the target hip joint agree to stop using similar analgesics 2 weeks prior to administration with only celecoxib as a relief medication; patients using opioids or chondroitin glucosamine etc. must agree to stop using such medications starting 2 weeks prior to administration. 6. Understand agree to this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of intra-articular infection surgery or injection treatment within 6 months prior to administration; 2. Diseases that may interfere with hip joint function assessment such as symptomatic low back pain or lumbar disc herniation affecting the target hip joint; 3. Local diseases that may confuse hip joint function assessment including but not limited to avascular necrosis of the femoral head pyogenic arthritis reactive arthritis clinically recurrent pseudogout chondrocalcinosis villonodular synovitis synovial chondromatosis joint fractures and intra-articular or periarticular tumors; 4. Individuals with a tendency to fall or gait instability requiring medical care; 5. Clinically significant systemic inflammation rheumatic diseases or connective tissue diseases including but not limited to rheumatoid arthritis psoriatic arthritis ankylosing spondylitis gout Paget's disease systemic lupus erythematosus or other systemic diseases that may confuse HOA assessment (such as fibromyalgia); 6. Individuals receiving chronic immunosuppressive transplant treatment or in a state of chronic immunosuppression including the use of systemic steroids/corticosteroids; 7. Various severe systemic diseases such as tumors mental illnesses neurological diseases respiratory diseases heart diseases liver dysfunction kidney dysfunction severe autoimmune diseases and hematological diseases; 8. Uncontrolled hypertension: systolic blood pressure (SBP) >160 mmHg and/or diastolic blood pressure (DBP) >100 mmHg; 9. History of alcohol abuse and illicit drug use; 10. Pregnant or breastfeeding women or male or female patients with a positive blood pregnancy test at screening or planning for contraception within 3 months after medication; 11. Patients who participated in other drug or device clinical trials within 3 months prior to medication; 12. Individuals allergic to the study drug or with a history of allergic constitution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "Harris Hip Score"; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantitative Scoring Standard for Traditional Chinese Medicine Syndromes;Hip Disability and Osteoarthritis Outcome Score;Inflammatory cytokines; | — |
Countries
China
Contacts
Public ContactSheng-yi Feng
Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medi
Outcome results
None listed