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

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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis; Chronic Musculoskeletal Disease
• Intervention / Treatment: Drug: Tong-Luo-Qu-Tong Plaster; Drug: Qi-Zheng-Xiao-Tong Plaster

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xuejun Cui, Doctor; Phone Number: 1309 021-64385700; Email: 13917715524@139.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Longhua Hospital, Shanghai university of TCM
      • Contact: Xuejun Cui, Dr; Phone Number: 1309 021-64385700; Email: 13917715524@139.com
      • Principal Investigator: Yongjun Wang, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC scores	Western Ontario and McMaster universities osteoarthritis index, ranges 0-96. Higher values represent a worse outcome.	from baseline to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TCM syndrome quantitative scores	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.	from baseline to 2 weeks
Visual analogue pain scale	Visual Analog Scale /Score ranges 0-10.Higher values represent a worse outcome.	from baseline to 2 weeks
On effective time of pain relief of drug	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.	In 2 weeks

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Liaoning University of Traditional Chinese Medicine; Hubei Hospital of Traditional Chinese Medicine; The Second Hospital of Nanjing Medical University; Zhongnan Hospital Affiliated to Wuhan University; Suzhou Hospital of Traditional Chinese Medicine; Luoyang Osteopathy hospital of Henan; The Fourth Central Hospital of Tianjin
• Investigators: Principal Investigator: Yongjun Wang, Doctor, Longhua Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Anticipated): December 20, 2019
• Study Completion (Anticipated): September 20, 2020

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Knee osteoarthritis; Randomised Double-blind Controlled trial; Tong-Luo-Qu-Tong Plaster
• Additional Relevant MeSH Terms: Joint Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Musculoskeletal Diseases
• Other Study ID Numbers: TLQT Plaster

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No