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Tong-Luo-Qu-Tong Plaster for KOA: a Randomised, Double-blind, Parallel Positive Control, Multi-center Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309501
Recruitment Status : Unknown
Verified November 2017 by Cui xuejun, Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : October 13, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborators:
Zhongnan Hospital Affiliated to Wuhan University
Suzhou Hospital of Traditional Chinese Medicine
Luoyang Osteopathy hospital of Henan
Hubei Hospital of Traditional Chinese Medicine
Liaoning University of Traditional Chinese Medicine
The Second Hospital of Nanjing Medical University
The Fourth Central Hospital of Tianjin
Information provided by (Responsible Party):
Cui xuejun, Shanghai University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Chronic Musculoskeletal Disease Drug: Tong-Luo-Qu-Tong Plaster Drug: Qi-Zheng-Xiao-Tong Plaster Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: positive control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : September 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Tong-Luo-Qu-Tong Plaster group
Intervention: Tong-Luo-Qu-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses
Drug: Tong-Luo-Qu-Tong Plaster
for 14 days as two period of treatment, daily 1 time.

Active Comparator: Qi-Zheng-Xiao-Tong Plaster group
Intervention: Qi-Zheng-Xiao-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses
Drug: Qi-Zheng-Xiao-Tong Plaster
for 14 days as two period of treatment, daily 1 time




Primary Outcome Measures :
  1. WOMAC scores [ Time Frame: from baseline to 2 weeks ]
    Western Ontario and McMaster universities osteoarthritis index, ranges 0-96. Higher values represent a worse outcome.


Secondary Outcome Measures :
  1. TCM syndrome quantitative scores [ Time Frame: from baseline to 2 weeks ]
    Referring to the Guidelines on the clinical research of Chinese medicine new drugs(2002), the TCM syndrome quantitative score ranges 0-21.Higher values represent a worse outcome.

  2. Visual analogue pain scale [ Time Frame: from baseline to 2 weeks ]
    Visual Analog Scale /Score ranges 0-10.Higher values represent a worse outcome.

  3. On effective time of pain relief of drug [ Time Frame: In 2 weeks ]
    The effective time of pain relief was the time of 10mm was reduced for the first time according to the daily VAS score of the patient's diary.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309501


Contacts
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Contact: Xuejun Cui, Doctor 021-64385700 ext 1309 13917715524@139.com

Locations
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China, Shanghai
Longhua Hospital, Shanghai University of TCM Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xuejun Cui, Dr    021-64385700 ext 1309    13917715524@139.com   
Principal Investigator: Yongjun Wang, Dr         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Zhongnan Hospital Affiliated to Wuhan University
Suzhou Hospital of Traditional Chinese Medicine
Luoyang Osteopathy hospital of Henan
Hubei Hospital of Traditional Chinese Medicine
Liaoning University of Traditional Chinese Medicine
The Second Hospital of Nanjing Medical University
The Fourth Central Hospital of Tianjin
Investigators
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Principal Investigator: Yongjun Wang, Doctor Longhua Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cui xuejun, associate professor, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03309501    
Other Study ID Numbers: TLQT Plaster
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cui xuejun, Shanghai University of Traditional Chinese Medicine:
Knee osteoarthritis
Randomised Double-blind Controlled trial
Tong-Luo-Qu-Tong Plaster
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Musculoskeletal Diseases
Arthritis
Joint Diseases
Rheumatic Diseases