Tong-Luo-Qu-Tong Plaster for KOA: a Randomised, Double-blind, Parallel Positive Control, Multi-center Clinical Trial
NCT ID: NCT03309501
Last Updated: 2017-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
2000 participants
INTERVENTIONAL
2017-09-12
2020-09-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tong-Luo-Qu-Tong Plaster group
Intervention: Tong-Luo-Qu-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses
Tong-Luo-Qu-Tong Plaster
for 14 days as two period of treatment, daily 1 time.
Qi-Zheng-Xiao-Tong Plaster group
Intervention: Qi-Zheng-Xiao-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses
Qi-Zheng-Xiao-Tong Plaster
for 14 days as two period of treatment, daily 1 time
Interventions
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Tong-Luo-Qu-Tong Plaster
for 14 days as two period of treatment, daily 1 time.
Qi-Zheng-Xiao-Tong Plaster
for 14 days as two period of treatment, daily 1 time
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
40 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Suzhou Hospital of Traditional Chinese Medicine
OTHER
Luoyang Osteopathy hospital of Henan
UNKNOWN
Hubei Hospital of Traditional Chinese Medicine
OTHER
Liaoning University of Traditional Chinese Medicine
OTHER
The Second Hospital of Nanjing Medical University
OTHER
The Fourth Central Hospital of Tianjin
UNKNOWN
Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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Cui xuejun
associate professor
Principal Investigators
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Yongjun Wang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Longhua Hospital
Locations
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Longhua Hospital, Shanghai University of TCM
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xuejun Cui, Dr
Role: primary
References
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Xu BP, Yao M, Tian ZR, Zhou LY, Yang L, Li ZJ, Zhu S, Wang XT, Lan JH, Wang YJ, Cui XJ. Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomized, double-blind, parallel positive controlled, multi-center clinical trial. Trials. 2019 Jun 24;20(1):377. doi: 10.1186/s13063-019-3481-6.
Other Identifiers
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TLQT Plaster
Identifier Type: -
Identifier Source: org_study_id