osteoarthritis
Conditions
Interventions
Experimental group:Oral celecoxib capsule + Jingulian capsule
Control group:Oral celecoxib capsule + Jingulian capsule simulator
Sponsors
The Affiliated Hospital of Changchun University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 40-75 years old, gender is not limited; 2. meet the diagnostic criteria for knee osteoarthritis, and refer to the "Guidelines for the Diagnosis and Treatment of Osteoarthritis" of the Division of Joint Surgery, Branch of Osteology, Chinese Medical Association, 2021; 3. Kellgren & Lawrence Grade I to ? for X-ray changes; 4.VAS score 4~6 points; 5. No oral or topical analgesics or similar proprietary Chinese medicines were used in the 1 week before enrollment; 6. Liver function: Serum total bilirubin (STB), bound bilirubin (CB, alanine aminotransferase (ALT), aspartate aminotransferase (AST)) = upper limit of normal (ULN) ×1.5; 7.Kidney function: serum creatinine (Cr) = upper limit of normal (ULN); 8.Patients voluntarily sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Women of childbearing age who are pregnant and breastfeeding or who are trying to conceive; 2. known allergy to NSaids; 3.known allergy to sulfanilamide; 4. Patients of TCM dialectical classification as heat arthralgia; 5. Patients enrolled in clinical studies of other drugs within 1 month; 6. Patients who have received arthroscopic injections within 1 month; 7 Patients who have received hormone therapy within 1 month; 8. Patients who had knee or hip surgery that caused pain or affected joint function within the 3 months prior to enrollment; 9. Other concomitant diseases or complications that may affect the observation of efficacy (local skin damage, infection; Rash, etc.); Patients with aspirin-induced asthma or a history of asthma, bronchial asthma; Perioperative patients undergoing coronary artery bypass grafting (CABG); Patients with a history of gastrointestinal bleeding or perforation following the use of NSaids; Patients with active gastrointestinal ulcers/bleeding, or previous recurrent ulcers/bleeding; Patients with severe heart failure and other patients with cardiovascular, lung, liver, kidney, hematopoietic system and other serious diseases, as well as serious articular manifestations such as high fever, interstitial pneumonia, kidney amyloidosis, constrictive pericarditis, central nervous system vasculitis need to use glucocorticoids. 10. The researchers considered that it was not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Arthritis Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| visual analogue scale;Traditional Chinese Medicine Syndrome Score Scale;12-Item Short Form Survey;Safety related index; | — |
Countries
China
Contacts
Public ContactWenhai Zhao
The Affiliated Hospital of Changchun University of Chinese Medicine
Outcome results
None listed