Status:
UNKNOWN
Tong-Luo-Qu-Tong Plaster for KOA: a Randomised, Double-blind, Parallel Positive Control, Multi-center Clinical Trial
Lead Sponsor:
Shanghai University of Traditional Chinese Medicine
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Suzhou Hospital of Traditional Chinese Medicine
Conditions:
Knee Osteoarthritis
Chronic Musculoskeletal Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
Knee osteoarthritis(OA), also known as degenerative arthritis, have affected a lot of people. Patients with severe osteoarthritis frequently develop one or more of the typically following symptoms: jo...
Detailed Description
A randomised, double-blind, parallel positive controlled, multicenter clinical trial will be conducted to assess the effectiveness and safety of Tong-Luo-Qu-Tong Plaster on patients with knee osteoart...
Eligibility Criteria
Inclusion
- Participants who have symptomatic knee osteoarthritis, diagnosis of KOA was based on criteria developed by the American College of Rheumatology(ACR) in 1986
- The differentiation standard of the arthralgia syndrome of traditional Chinese medicine(TCM): Referring to the Guidelines on the clinical research of Chinese medicine new drugs(2002)
- The visual analog scale score is no less than 30 mm.
- The patient is older than or equal to 40 years old
- All the patients signed informed consent form before study begins
Exclusion
- Hormone therapy was used in the first month of screening
- Arthroscopy and intra-articular injection was performed on the knee joint which is going to be evalued during the first three months of screening.
- There is a history of trauma or surgery in the knee joint six months before screening or participants who a history of lessmore than three trauma or surgical procedures in the knees
- Participants who have knee arthroplasty, lumbar spinal stenosis, ankylosing spondylitis, rheumatic arthritis, rheumatoid factor positive(\>40), eallergic constitution and mental disorder will be excluded from the trial
- Patients has severe diseases and complications such as severe diabetes, serious liver and kidney disease, malignant tumors, infectious diseases or complications affecting the knee joints
- Pregnant,lactating women
- Subjects are participating in or have participated in other clinical trials in the first three months.
- Subjects cannot stop using the drugs immediately with a long-term use of other related drugs.
- Combined with severe primary diseases such as hepatic renal functionand hematopoietic system, such as liver function (ALT≧1.5×ULN), and kidney function(AST≧1.5×ULN)
Key Trial Info
Start Date :
September 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2020
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT03309501
Start Date
September 12 2017
End Date
September 20 2020
Last Update
November 9 2017
Active Locations (1)
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1
Longhua Hospital, Shanghai University of TCM
Shanghai, Shanghai Municipality, China, 200032