osteoarthritis of the knee
Conditions
Interventions
Test drug group:1 patch each time, applied to the knee joint of the target side, once a day, for 4 weeks
Positive control group:1 patch each time, applied to the knee joint of the target side, once a day, for 4 weeks
Placebo group:1 patch each time, applied to the knee joint of the target side, once a day, for 4 weeks
Sponsors
Nanjing Gulou Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Male or female, between the ages of 40 and 75 (inclusive); (2) The diagnosis of osteoarthritis of the knee was made with reference to the criteria of the Osteoarthritis Diagnostic Guidelines (2018 edition); (3) Knee pain on the target side lasting at least 1 month; (4) Kellgren-Lawrence grading of the target lateral knee was graded I-III; (5) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores for "walking on flat surfaces" activity pain VAS score >=40 mm and =225 mm; (6) Western Ontario and McMaster Universities Osteoarthritis Index in the non-target side knee joints(WOMAC) pain score for "walking on level ground" activity pain VAS score <40 mm(0~100 mm); (7) Ability to walk independently; (8) Ability to provide written informed consent to participate in the study and ability to understand the trial process and trial requirements.
Exclusion criteria
Exclusion criteria: (1) Prior hypersensitivity (including the development of symptoms caused by aspirin or other NSAIDs, such as bronchospasm, rhinitis, or urticaria) to the components of the drug used in this trial, to remedial medications, or to any other NSAIDs; (2) Knee pain is caused by other inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis, villonodular synovitis, and septic arthritis; (3) Osteoarthritis caused by osteomyelitis, bone tumors and bone tuberculosis; (4) Lower extremity disability, which in the judgment of the investigator affects the assessment of efficacy; (5) Comorbidities that cause other lower extremity pain, such as goosefoot bursitis and intermittent claudication; (6) Lesions such as skin breaks and rashes in the area of the target knee; (7) The lower extremity on the target side suffers from peripheral vascular, skeletal, or muscular disease; (8) Presence of a pathologic joint cavity effusion requiring aspiration or indication for surgery; (9) Suffered from frequent headaches and other disorders prior to randomization that, in the judgment of the investigator, will require use during the trial of non Steroidal anti-inflammatory drugs or other analgesic drugs; (10) Open knee trauma or arthroscopy, joint lavage, cleaning, or other knee surgery within 1 year prior to randomization; (11) Received intra-articular knee drug injections such as glucocorticoids, sodium vitrate, medical chitosan, growth factors, and platelet-rich plasma within 3 months prior to randomization; (12) Use of systemic corticosteroids or immunosuppressive drugs within 4 weeks before randomization; (13) The drug washout period was determined based on the half-life of the drug if it was used prior to randomization (except for remedial use) in the treatment of osteoarthritis with a western or Chinese drug. If the half-life of the drug is known, the washout period is set to 5 half-lives. If the half-life of the drug is not known, the default washout period is 1 week; (14) Any therapies other than Chinese or Western medications that can be used for the treatment of osteoarthritis, such as acupuncture and tuina, had been used within 1 week prior to randomization; (15) Previous or current history of upper gastrointestinal ulcers, bleeding may, in the judgment of the investigator, place the participant at significant risk; (16) Have severe, poorly controlled cardiac, renal, or hepatic disease and known bleeding disorders or are on medications that can affect coagulation, which in the judgment of the investigator may place the participant at significant risk and have an impact on the results of the study; (17) Liver function ALT, AST> 2 times the upper limit of normal, or blood creatinine > 1.5 times the upper limit of normal; (18) Comorbid psychiatric disorders (e.g., schizophrenia, anxiety, depressive states, etc.) or cognitive dysfunction that, in the judgment of the investigator, make participation in the trial inadvisable; (19) Participation in any other clinical trial within 3 months prior to signing informed consent (except for treatment-free controls that have been discharged); (20) Participants (including males) who are pregnant or breastfeeding females, or who plan to have children within 3 months, or who do not agree to use effective contraception during the trial; (21) Participants with poor adherence to medication and regular follow-up appointments; (22) Participants judged by the investigator to be unsuitable for this
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Value of change from baseline in VAS score for question 1 (walking on a level road) of the WOMAC pain subscale for the target side knee at week 4; | — |
Secondary
| Measure | Time frame |
|---|---|
| Value of change from baseline in VAS score for question 1 (walking on a level road) of the WOMAC pain subscale for the target side knee at weeks 1 and 2;Change from baseline values of VAS scores on the WOMAC pain subscale for the target side knee at weeks 1, 2, and 4;Change from baseline values of VAS scores on the WOMAC stiffness subscale for the target side knee at weeks 1, 2, and 4;Change from baseline values of VAS scores on the WOMAC Physical Function subscale for the target knee at weeks 1, 2, and 4;Change from baseline in total WOMAC VAS scores for all subscales for the target knee at weeks 1, 2, and 4;Patient General Impression of Change Scale (PGIC) score at week 4;Week 4 Clinical General Impression of Change Scale (CGIC) score;Remedial drug dosing over 4 weeks of treatment; | — |
Countries
China
Contacts
Public ContactQing Jiang
Nanjing Gulou Hospital
Outcome results
None listed