Knee Osteoarthritis
Conditions
Interventions
Cohort 1: Intraarticular Sodium Hyaluronate Injection combined with oral Bulleyaconitine Soft Capsules, administered orally for 4 consecutive weeks and intraarticularly once weekly for a total of 5 in
Cohort 3: Oral NSAIDs alone for 4 consecutive weeks:None
Cohort 2: Oral Bulleyaconitine Soft Capsules alone for 4 consecutive weeks:None
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients aged >=40 years; 2.Diagnosed with primary knee osteoarthritis (according to the 2018 edition of the Chinese Guidelines for Diagnosis and Treatment of Osteoarthritis; 3.Kellgren-Lawrence(K-L) grade I–III on knee radiographs; 4.Not suitable for or unwilling to undergo surgical intervention; 5.Signed informed consent;
Exclusion criteria
Exclusion criteria: 1.Kellgren-Lawrence grade IV on knee radiographs; 2.Confirmed diagnosis of rheumatoid arthritis or other inflammatory arthritis, or judged by the investigator as highly suspected of having inflammatory arthritis and confirmed by the rheumatology and immunology department (including Rheumatoid Factor(RF) or Anti-Cyclic Citrullinated Peptide Antibody(anti-CCP) positivity with typical clinical manifestations); 3.Subjects deemed by the investigator to have poor compliance or any factors that make them unsuitable for participation in this trial; 4.Patients with coagulation disorders; 5.Positive tuberculosis T-SPOT or interferon-gamma release assay (IGRA), or history of tuberculosis; 6.Positive Hepatitis B Surface Antigen (HBsAg); 7.Pregnant or lactating women; 8.Alanine aminotransferase (ALT) or creatinine >2 × upper limit of normal (ULN); 9.History of Knee Joint Surgery or Knee Joint Trauma; 10.History of allergy to any of the study drugs, their excipients, or other drugs in the same class;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, severity, and causal relationship of Adverse Event(AE) and Serious Adverse Event (SAE);Incidence of Symptomatic Upper Gastrointestinal Adverse Reactions, Ulcers, and Ucer Complications (bleeding, perforation, and obstruction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in radiographic findings at Week 4: Joint Space Narrowing (JSN) and OsteOphytes;ROM(Change in knee joint Range of Motion (ROM) score at week 4);Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at week 4;Change in Lequesne Index of Severity for Knee Osteoarthritis score at Week 4; | — |
Countries
China
Contacts
Public ContactLidong Wu
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed