Osteoarthritis
Conditions
Interventions
control group:Guidelines recommend first-line treatment drugs for osteoarthritis (NSAIDs)
Experimental group:Compound Xiaohuoluo Pill used alone or in combination with NSAIDs
Sponsors
Guanganmen Hospital CHINA ACADEMY OFCHINESE MEDICAL SCIENCES
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western diagnostic criteria for hand or knee osteoarthritis; (2) Meets the traditional Chinese medicine differentiation criteria for cold dampness obstruction syndrome; (3) Pain Visual Analog Scale (VAS) = 40mm; (4) Age range of 40-75 years old (including boundary values) gender not limited; (5) Voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Other joint related diseases such as rheumatoid arthritis gout pseudogout reactive arthritis psoriatic arthritis ankylosing spondylitis Lyme disease connective tissue diseases such as lupus erythematosus Sjogren's syndrome scleroderma etc. or the presence of bone erosion (manifested as subchondral bone cystic degeneration resulting in an uneven cortical surface and interrupted continuity); (2) Merge with serious primary diseases such as cardiovascular and cerebrovascular diseases liver and kidney diseases hematopoietic system diseases digestive system diseases (such as digestive ulcers bleeding etc.) as well as mental illnesses or other serious diseases that affect their survival; When screening measure the systolic blood pressure = 160mmHg and/or diastolic blood pressure = 100mmHg in a resting state (at least 10 minutes) after standardized treatment as well as other situations judged by the researcher to be unsuitable for participation in the trial; (3) Screening patients who received intra-articular injection of sodium hyaluronate within the first 6 months; Individuals with a history of trauma ligament injury fracture or surgery leading to pain or functional issues; (4) Individuals who have consumed excessive amounts of alcohol (more than 21 units per week where 1 unit equals 8g or 10mL of pure alcohol) within the past 3 months and are unable to stop drinking during medication (or using health supplements containing alcohol such as tiger bone wine); (5) Regular use of traditional Chinese patent medicines and simple preparations or decoction for the treatment of cold dampness stagnation syndrome within one week before screening and/or NSAIDs (such as aspirin ibuprofen loxoprofen diclofenac celecoxib meloxicam etc.) aminosugar chondroitin etc; (6) Individuals who are allergic to compound Xiaohuoluo pills NSAIDs or their components; (7) Preparing pregnant and lactating women during pregnancy or experimentation; (8) Screening individuals who have participated or are currently participating in other clinical trials within the previous 3 months; Other situations that researchers consider unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Health Assessment Questionnaire (HAQ) scores of subjects before and after treatment; Changes in VAS scores of joint pain in subjects before and after treatment ;Changes in osteoarthritis index scores of Western Ontario and McMaster University (WOMAC) before and after treatment in subjects;Changes in Functional Index of Hand Osteoarthritis (FIHOA) before and after Treatment in Subjects;Changes in the total score of traditional Chinese medicine syndrome and the disappearance rate of individual symptoms before and after treatment in the subjects;(2)Changes in VAS scores of joint numbness in subjects before and after treatment; | — |
Countries
China
Contacts
Public ContactTang Xiaopo
Guanganmen Hospital CHINA ACADEMY OFCHINESE MEDICAL SCIENCES
Outcome results
None listed