knee osteoarthritis
Conditions
Interventions
Trial Group:Wangbi capsules 5 capsules each time 3 times a day orally
Control Group:Wangbi capsule simulator 5 capsules each time 3 times a day orally.
Sponsors
Shuguang Hospital Affiliated Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Comply with the diagnosis of knee osteoarthritis; (2)TCM syndrome differentiation is liver and kidney deficiency wind and dampness stasis obstruction syndrome; (3)The Kellgren-Lawrence imaging grade of the target knee joint is I-III and the grade of the contralateral knee joint is not higher than that of the target side; Note: For the definition of target knee joint when the imaging grades of bilateral knee joints are different the knee joint with higher K-L grade is selected as the target knee joint; when the imaging grades are the same the knee joint with more severe pain is selected as the target knee joint; When the K-L grade and pain severity are the same the dominant side is selected as the target knee joint. (4)The WOMAC score of the target knee joint was=480mm(0~2400mm) and the WOMAC pain score was=200 mm; (5)Age 40-75 years old (including the boundary value) gender is not limited; (6)Body mass index (BMI)18.5-30kg/m2 (including 18.5kg/m2 excluding 30kg/m2); (7)Voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1)The researcher determines that there are diseases that may affect the target knee joint or its function and pain assessment such as rheumatoid arthritis rheumatoid arthritis bone and joint tuberculosis gouty arthritis infectious arthritis and joint trauma ( Fracture and dislocation acute joint trauma) III degree meniscus injury etc; (2)Both or any knee joints have undergone knee replacement surgery or there is a knee replacement plan during the study period; (3)Knee joint trauma or other surgical treatment within 6 months before screening; (4)Have undergone intra-articular treatment within 1 month before screening including intra-articular injection of drugs joint cavity flushing etc. (5)Those who have undergone systemic non-drug therapy within 2 weeks before screening such as acupuncture acupuncture cupping and pricking cupping manipulation physical therapy (including heat therapy cold therapy wax therapy electrotherapy magnetic therapy infrared irradiation hydrotherapy Ultrasound therapy etc.) (6)Those who have used systemic hormone therapy within 1 month before screening; (7)Those who have used drugs or health products (such as glucosamine chondroitin sulfate diacerein etc.) or other drugs for the treatment of knee osteoarthritis and related traditional Chinese medicines within 4 weeks before screening; (8)Patients with severe cardiovascular system digestive system nervous system urinary system endocrine system respiratory system immune system and other diseases that may affect the determination of efficacy and safety as determined by the researcher; (9)Abnormal liver function (ALT or AST>1.5×ULN) and abnormal kidney function (serum creatinine > 1×ULN); (10)Lactating or pregnant women; (11)History of drug or alcohol abuse; (12)Those who have had a history of severe allergies or are suspected of being allergic or those who are clearly allergic to this product and the analgesics allowed in the protocol or any of its excipients; (13)Those who have great difficulty understanding the scale or have poor compliance and are unable to adhere to medication and follow up on time; (14)Those who have participated in any other clinical trials within 3 months before screening; (15)The researcher determines that other reasons make it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index total score at each evaluation time point after treatment in the two groups compared with the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in WOMAC pain scores, stiffness scores, and joint activity scores at each evaluation time point after treatment in the two groups compared with baseline;Changes in pain VAS scores at each evaluation time point after treatment in the two groups compared with baseline;Changes in the total TCM syndrome score at each evaluation time point after treatment in the two groups compared with the baseline;Changes in single syndrome scores of TCM syndrome scores at each evaluation time point after treatment in the two groups compared with baseline;The proportion of K-L grade progress in the two groups before and after treatment;Changes in the total TCM syndrome score at each evaluation time point after treatment in the two groups compared with the baseline; | — |
Countries
China
Contacts
Public ContactYuan Wei'an Zheng Yuxin
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai
Outcome results
None listed