Clinical trial NCT05449613: Efficacy and Safety Evaluation of Acupoint Application in the Treatment of Knee Osteoarthritis Joint Pain
Official title: Efficacy and Safety Evaluation of Acupoint Application in the Treatment of Knee Osteoarthritis Joint Pain: a Randomized, Double-blind, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Knee Osteoarthritis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of acupoint application of Traditional Chinese medicine in the treatment of KOA joint pain through a prospective, randomized, double-blind, placebo-controlled clinical study.


Eligibility criteria: Inclusion Criteria:

1. Western medicine diagnosed as knee osteoarthritis, clinical classification is primary, and conforms to the TCM syndrome of cold and wet obstruction;
2. Guidelines for the diagnosis and treatment of osteoarthritis 2018 criteria and Kellgren -Lawrence\<Ⅲ;
3. VAS pain score ≥40mm (select the limb with the most obvious pain symptom);
4. For patients taking nonsteroidal drugs or other disease-improving drugs (such as cartilage protectants), the dose has been stable for at least 4 weeks;
5. Signed informed consent.

Exclusion Criteria:

1. Patients who underwent intra-articular therapy within 3 months prior to the trial or required relevant surgical treatment within 1 year；
2. Glucocorticoid and joint cavity injection were used 4 weeks before treatment;
3. swelling and heat of knee joint;
4. other diseases causing knee pain; Such as acute joint injury, tuberculous arthritis, rheumatoid arthritis, rheumatoid arthritis, suppurative arthritis, osteomyelitis, psoriatic arthritis, gout, villi nodular synovitis.
5. History or evidence of any of the following diseases during the screening period: serious cardiovascular and cerebrovascular diseases, active or recurrent ulcer of digestive system or other diseases at risk of bleeding, other serious diseases of digestive system, combined with malignant tumor, serious or progressive diseases of blood system or other systems.
6. Patients with other mental diseases who are unable to cooperate or unwilling to cooperate.
7. Before screening, any of the laboratory test indicators met the following criteria: ALT and AST \> 1.5 times the upper limit of normal value, Cr \> 1.2 times the upper limit of normal value, and other clinically significant laboratory test abnormalities, which were determined by the investigator to be unsuitable for inclusion in the group.
8. allergic constitution or allergic to test drugs, excipients or similar ingredients.
9. Suspected or confirmed history of alcohol or drug abuse;
10. pregnant or lactating women or those who have planned pregnancy recently and do not want to use contraception;
11. Participants in other clinical trials within 3 months prior to enrollment;
12. The investigator considered that the patients should not participate in the clinical trial.Other requirements for inclusion are willingness to participate for the duration of the trial. All patients will receive verbal and written information about the trial and sign a consent form before inclusion. The researcher obtains written consent before inclusion and randomisation.

Primary outcomes:
measure: Changes in VAS pain score from baseline 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in WOMAC scale scores from baseline
timeFrame: 4 weeks
measure: Health Measurement Scale (SF-36)
timeFrame: 4 weeks
measure: Number of Participants With Metabolic Abnormal Events at All Assessment Time Points.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References: