knee osteoarthritis and osteopenia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals aged 40 to 80, regardless of gender; 2. Meeting the diagnostic criteria of knee osteoarthritis in Western medicine, with Kellgren-Lawrence classification at grade I-II, and the bone density test result at the lumbar spine being -2.5 SD < T < -1.0 SD; 3. Knee joint pain during walking with a F-VAS score of 3 <= F-VAS score <= 6; 4. Participants voluntarily signed the informed consent form to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Patients with osteoporosis, history of brittle fractures, and history of fractures in the lumbar spine or knee joints; 2. Patients with diseases affecting bone metabolism, including hypogonadism, diabetes, various endocrine system diseases such as hyperthyroidism, rheumatic immune diseases, gastrointestinal diseases, hematological diseases, neuromuscular diseases, heart failure (NYHA classification of grade III-IV), etc.; 3. Patients with implanted devices in the lumbar spine or hip, and osteomalacia; 4. Patients requiring medications that affect bone metabolism, including glucocorticoids, proton pump inhibitors, antiepileptic drugs, aromatase inhibitors, gonadotropin-releasing hormone analogues, antiviral drugs, thiazolidinedione drugs, and excessive thyroid hormones, etc.; 5. Patients with recurrent knee joint swelling and effusion, progressive pain, significant joint dysfunction, and joint deformity, and poor response to non-surgical treatment; 6. Patients with hypercalcemia, hypercalciuria, and calcium-containing kidney stones; 7. Patients who need to take digitalis glycosides, tetracyclines and quinolone antibacterial drugs, aluminum-containing antacids or aluminum-containing antacids during the study period; 8. Patients known to be allergic to the components of the trial food products; 9. Patients whose AST or ALT or ALP levels were greater than 2 times the upper limit of normal (ULN) during the screening period, or whose serum creatinine was greater than 1.5 times the ULN; 10. Pregnant and lactating women, and patients who refuse to take contraceptive measures throughout the study; 11. Those who have participated in other clinical trials in the past 3 months or are currently participating in other clinical trials; 12. Those suspected to have a confirmed history of drug abuse; 13. Patients considered not suitable for inclusion in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the F-VAS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC daily adctivity score;Usage of emergency medications;Incidence of falls;WOMAC pain score;WOMAC stiffness score;bone density;Clinical symptom score;physical examination;Serum Chemistry;WOMAC total score;bone metabolism indicators;vital signs;Hematology;the F-VAS score;SF-36 scale; | — |
Countries
China
Contacts
Guangdong Provincial Hospital of Chinese Medicine