Mechanism research for external therapy of warming channels activating blood circulation early treating knee osteoarthritis based on metabonomics technique

Phase 1

• Conditions: knee osteoarthritis

• Registration Number: ITMCTR1900002330
• Lead Sponsor: Jiangsu Provinve Hospital of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1 Meet the western medical diagnostic criteria for knee osteoarthritis: adopt the 2015 American orthopaedic surgeons association knee joint bone
Evidence-based guidelines for arthritis:
(1) Repeated pain in the knee joint within a month.
(2) X-ray (standing position or weight-bearing position) showed narrowing of joint space, subchondral osteosclerosis and/or cystic degeneration, formation of marginal osteophytes.
(3) Articular fluid (at least twice) is clear and thick, WBC < 2000/ml.
(4) Middle-aged and elderly patients (40 years old).
(5) Morning stiffness 30 minutes.
(6) Bone friction when moving.
Note: combined with clinical, laboratory and X-ray examination, 1+2 or 1+3+5+6 or 1+4+5+6 were diagnosed as osteoarthritis of knee joint.
2 Above 40 years old;
3 If the patient has received other non-surgical treatment, after 7 days of washout period;
4 Signed the informed consent.

Exclusion Criteria

(1) knee osteoarthritis with acute synovitis;
(2) knee joint tuberculosis, tumor, rheumatoid arthritis, rheumatoid arthritis;
(3) and affect the joint, such as psoriasis, plum toxic neuropathy, brown and yellow disease, metabolic bone disease,Acute trauma, etc.
(4) received systemic or intra-articular hormone therapy within nearly 60 days, and the knee joint within 3 months
Intracavitary injection or arthroscopy;
(5) injured skin damage, or other diseases affect the local injury medicine, such as skin diseases;
(6) allergy patients;
(7) women who are lactating, during pregnancy or are preparing for pregnancy;
(8) patients who are participating in clinical trials of other drugs;
(9) in addition to osteoarthritis of the knee, pain relievers (eg acetyl Aminophenol, nonsteroidal anti-inflammatory drugs, nonprescription compounds containing analgesics, and possibly analgesics Sexual ingredients of traditional Chinese medicine, local painkillers) were used for other chronic or recurrent pain;
(10) attending according to the researcher's judgment, attending may reduce the possibility of admission or other attending complications A condition, such as frequent changes in the working environment, that may cause loss of access.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Security Index;Diagnostic indicators;biological indicator;Serum metabolomics analysis based on liquid chromatography mass spectrometry;Local skin irritation;WOMAC Total score and joint function grading;