Clinical trial NCT03309501: Tong-Luo-Qu-Tong Plaster for KOA: a Randomised, Double-blind, Parallel Positive Control, Multi-center Clinical Trial
Official title: Study on Efficacy, Safety and Economy of Tong-Luo-Qu-Tong Plaster Treatment for Knee Osteoarthritis: Study Protocol for a Randomised, Double-blind, Parallel Positive Control, Multi-center Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Knee Osteoarthritis
Chronic Musculoskeletal Disease
Keywords: Knee osteoarthritis
Randomised Double-blind Controlled trial
Tong-Luo-Qu-Tong Plaster
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Suzhou Hospital of Traditional Chinese Medicine
name: Luoyang Osteopathy hospital of Henan
name: Hubei Hospital of Traditional Chinese Medicine
name: Liaoning University of Traditional Chinese Medicine
name: The Second Hospital of Nanjing Medical University
name: The Fourth Central Hospital of Tianjin
First posted: 2017-10-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: positive control
Primary purpose: TREATMENT

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: joint pain, stiffness, activity with joint friction noise, limited mobility, such as difficulty walking and climbing. Now there are many western medicine treatments including symptom relief and joint cartilage protective agents for OA, but the results have not yet satisfied. TCM treatment of osteoarthritis has remarkable curative effect and unique advantage.Tong-Luo-Qu-Tong Plaster is a common method to treat osteoarthritis of the knee for thousands of years in China. It lacked a large sample randomised, double-blind, parallel positive controlled, multicenter clinical trial, and the clinical evidence of Tong-Luo-Qu-Tong Plaster for Knee Osteoarthritis need to be further completed.

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 osteoarthritis. A total of 2000 patients with knee osteoarthritis will be recruited and randomly allocated into experimental group(1500) or control group(500). Each patient will undergo a 2-week treatment with herbal patches for one session per day.The western Ontario and McMaster universities osteoarthritis index (WOMAC) as objective indicators of efficacy is the primary efficacy endpoint of the study.The secondary outcome measures are the changes in TCM syndrome quantitative score, Visual Analog Scale/Score (VAS) score of pain, and the effective time of pain relief of drug from the baseline to 1 week, 2 weeks' follow-up.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: WOMAC scores
timeFrame: from baseline to 2 weeks
Secondary outcomes:
measure: TCM syndrome quantitative scores
timeFrame: from baseline to 2 weeks
measure: Visual analogue pain scale
timeFrame: from baseline to 2 weeks
measure: On effective time of pain relief of drug
timeFrame: In 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of TCM
state: Shanghai
Study officials:
affiliation: Longhua Hospital
name: Yongjun Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.