Last updated: July 4, 2022
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting
Phase
3
Condition
Osteoarthritis
Arthritis And Arthritic Pain
Muscle Pain
Treatment
N/AClinical Study ID
NCT05449613
2022-077-KY
Ages 40-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Western medicine diagnosed as knee osteoarthritis, clinical classification is primary,and conforms to the TCM syndrome of cold and wet obstruction;
- Guidelines for the diagnosis and treatment of osteoarthritis 2018 criteria andKellgren -Lawrence<Ⅲ;
- VAS pain score ≥40mm (select the limb with the most obvious pain symptom);
- For patients taking nonsteroidal drugs or other disease-improving drugs (such ascartilage protectants), the dose has been stable for at least 4 weeks;
- Signed informed consent.
Exclusion
Exclusion Criteria:
- Patients who underwent intra-articular therapy within 3 months prior to the trial orrequired relevant surgical treatment within 1 year;
- Glucocorticoid and joint cavity injection were used 4 weeks before treatment;
- swelling and heat of knee joint;
- 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.
- History or evidence of any of the following diseases during the screening period:serious cardiovascular and cerebrovascular diseases, active or recurrent ulcer ofdigestive system or other diseases at risk of bleeding, other serious diseases ofdigestive system, combined with malignant tumor, serious or progressive diseases ofblood system or other systems.
- Patients with other mental diseases who are unable to cooperate or unwilling tocooperate.
- 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 upperlimit of normal value, and other clinically significant laboratory test abnormalities,which were determined by the investigator to be unsuitable for inclusion in the group.
- allergic constitution or allergic to test drugs, excipients or similar ingredients.
- Suspected or confirmed history of alcohol or drug abuse;
- pregnant or lactating women or those who have planned pregnancy recently and do notwant to use contraception;
- Participants in other clinical trials within 3 months prior to enrollment;
- The investigator considered that the patients should not participate in the clinicaltrial.Other requirements for inclusion are willingness to participate for the durationof the trial. All patients will receive verbal and written information about the trialand sign a consent form before inclusion. The researcher obtains written consentbefore inclusion and randomisation.
Study Design
Total Participants: 120
Study Start date:
October 01, 2021
Estimated Completion Date:
October 01, 2024
Connect with a study center
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing 100052
ChinaActive - Recruiting
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