Knee osteoarthritis
Conditions
Interventions
Treatment group:Oral knee paralysis, according to the results of clinical diagnosis of Chinese medicine, with the addition and subtraction of the application of 200mL / bag. 1 bag / time, 2 times / d,
Control group:Oral celecoxib capsules (Pfizer Pharmaceuticals Ltd.).200mL / bag, 1 bag/times, 1 times/d oral, 1 week for a course of treatment, continuous treatment for 2 courses.
Sponsors
Chongqing Nanchuan District Hospital of Traditional Chinese medicine
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: Western medical diagnostic criteria: the diagnostic criteria for knee arthritis were formulated with reference to the diagnostic criteria for knee arthritis in the Osteoarthritis Diagnostic and Treatment Guidelines ( 2018 edition) [17]. Repeated pain in the knee joint in the past 1 month; ? X-ray (standing or weight-bearing). ? X-ray (standing position or weight-bearing position) shows narrowing of the joint space, subchondral osteosclerosis and/or cystic degeneration, and formation of joint margins; Age =40 years; Morning stiffness time =30 min; ? Bone friction sound (sensation) during activity. Diagnosis can be made if ? and any other 2 criteria are met. Diagnostic criteria of Chinese medicine: refer to Chinese medicine diagnosis and treatment guideline of osteoarthritis of the knee (2020 edition)18]. Primary symptom Heavy pain in joints, aggravated by cold, reduced by warmth, and unfavourable flexion and extension of joints; Secondary symptoms Heavy pain in the lower back Tongue and pulse The tongue is pale with white fur and the pulse is moist and slow. Inclusion criteria: ? Meet the above diagnostic criteria; ? Meet the above diagnostic criteria. ? Meet the identification criteria of cold-damp paralysis and obstruction in traditional Chinese medicine; (iii) Age from 40 to 75 years old (including 40 and 75 years old), gender is not limited; ? Bilateral knee patients shall be treated on the heavy side; ? Have normal understanding and communication ability, participate in the study voluntarily after understanding the main points of the study, and sign the informed consent form.Translated with DeepL.com (free version)
Exclusion criteria
Exclusion criteria: (1) Diseases such as deforming osteoarthritis (Paget's disease of bone), joint fracture, severe dysplasia or congenital anomalies, xanthochromia, lupus, acromegaly, haemochromatosis, hepatomegaly, primary chondromatosis, or osteoarthritis of lower extremity joints other than the knee, which in the opinion of the investigator, may interfere with the assessment of pain and function of the knee joint; (2) History of chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, gouty arthritis, fibromyalgia, etc; (3) Body mass index (BMI) at =35kg/m2; (4) Abnormal limb function caused by abnormal nerve function; (5) Acupuncture, intervention or local closure treatment 1 month before treatment; (6) Use of non-steroidal anti-inflammatory drugs (except for long half-life drugs such as celecoxib, meloxicam, and nabumetone) within 7 days prior to randomisation; (7) Use of, or planned use of, opioids, or corticosteroid therapy within 30 days prior to screening or during the study period (except that subjects requiring only inhaled corticosteroids for asthma may be enrolled); (8) Intraluminal steroid injections, viscoelastic supplements, or arthroscopy of the study side knee within 3 months prior to screening; (9) Trauma or surgery to the study knee within 6 months prior to Screening; (10) Patients with serious primary diseases of the heart, liver, kidneys, brain and haematopoietic system; (11) Allergies or skin ulceration in the affected area; (12) Nursing or pregnant women; (13) Subjects with known alcohol or drug abuse; (14) Participation of the subject in any other clinical trial within the past 3 months; (15) In the opinion of the Investigator, any other condition that jeopardises the subject's safety, affects the Investigator's assessment, or is poorly adherent to the protocol. Note: Patients who meet any of the above criteria are not eligible for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint ultrasound;Enzyme-linked immunosorbent assay, ELISA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lequesne score;Visual analogue scale; | — |
Countries
China
Contacts
Public ContactShibo Peng
Chongqing Nanchuan District Hospital of Traditional Chinese medicine
Outcome results
None listed