Knee osteoarthritis (type with liver and kidney deficiency)
Conditions
Interventions
Sponsors
Wangjing Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: Participants must be aged =50 years, with no gender restriction [16]; meet the Western medical diagnostic criteria for knee osteoarthritis [16]; have unilateral knee involvement, or a contralateral knee joint score (WOMAC) not exceeding that of the target side, with no pharmacological treatment required for the contralateral knee during the study; satisfy the Traditional Chinese Medicine syndrome differentiation criteria for liver-kidney deficiency pattern [17]; at screening, the VAS score for pain during walking on flat ground in the target knee should be =7, and the pain subscale score on the Western University of Ontario and McMaster University Osteoarthritis Index (WOMAC) scale should be =5 [18]; participants must understand and comply with the study protocol, provide informed and voluntary consent, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Other conditions that may confound the assessment of target knee joint function and pain include: systemic diseases potentially affecting joints (e.g., gouty arthritis, rheumatoid arthritis), chronic inflammatory or connective tissue diseases, neurological disorders, Paget's disease involving the knee, localized pain caused by nerve root syndrome-related lumbar compression, or any other conditions that could interfere with efficacy evaluation; use of corticosteroids within one month prior to screening; administration of nonsteroidal anti-inflammatory drugs, benzothiazines, glucosamine, chondroitin sulfate, or other knee osteoarthritis treatments-including traditional Chinese medicines-within three weeks before screening [16]; intra-articular treatments (including intra-articular injections, joint lavage, or simple arthroscopy) performed or planned during the trial within three months prior to screening; arthroscopic surgery, joint replacement, or other open knee procedures (excluding simple arthroscopy) performed on the non-target knee within six months before screening, or on the target knee previously; severe cardiovascular or cerebrovascular diseases, chronic liver disease (ALT/AST =1.5× upper limit of normal reference range), or renal disease (serum creatinine> upper limit of normal reference range) [19]; known immunodeficiencies (e.g., uncured or active malignancies, organ/bone marrow transplantation, or recent use of immunosuppressants within three months) [19]; pregnancy, suspected pregnancy, planned pregnancy (within three months after study completion), or lactation [19]; individuals with allergic predisposition or known hypersensitivity to trial medications [19]; and patients who participated in other clinical studies within three months prior to screening. Patients with comorbid mental disorders or cognitive impairments who were unable to cooperate with the investigators [19]; patients deemed by investigators as intolerant to the study drug, or those with any other contraindications to participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Score of WOMAC Scale;Changes from baseline in pain, stiffness and physical function subscale scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in total WOMAC scale score after 2 weeks of treatment;Changes from baseline in WOMAC pain, stiffness and physical function subscale scores after 2 weeks of treatment;Onset time of pain relief;Time to pain resolution;Proportions of pain onset and pain resolution at 2 and 4 weeks of treatment;Changes from baseline in pain VAS scores at 2 and 4 weeks of treatment;Area under the curve (AUC) of knee pain VAS scores during the trial;Changes from baseline in individual item scores and total score of TCM syndrome after 2 and 4 weeks of treatment; | — |
Countries
China
Contacts
Public ContactHongmei Zhang
Wangjing Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed