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

NCT03309501 | Unknown Phase 3 DMC

• 1 other identifier: TLQT Plaster
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Chronic Musculoskeletal Disease

Keywords

Knee osteoarthritis; Randomised Double-blind Controlled trial; Tong-Luo-Qu-Tong Plaster

Outcome Measures

Primary Outcomes (1)

• WOMAC scores

  Western Ontario and McMaster universities osteoarthritis index, ranges 0-96. Higher values represent a worse outcome.

  from baseline to 2 weeks

Secondary Outcomes (3)

• TCM syndrome quantitative scores

  from baseline to 2 weeks

• Visual analogue pain scale

  from baseline to 2 weeks

• On effective time of pain relief of drug

  In 2 weeks

Study Arms (2)

Tong-Luo-Qu-Tong Plaster group

EXPERIMENTAL

Intervention: Tong-Luo-Qu-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses

Drug: Tong-Luo-Qu-Tong Plaster

Qi-Zheng-Xiao-Tong Plaster group

ACTIVE COMPARATOR

Intervention: Qi-Zheng-Xiao-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses

Drug: Qi-Zheng-Xiao-Tong Plaster

Interventions

Tong-Luo-Qu-Tong Plaster DRUG

for 14 days as two period of treatment, daily 1 time.

Tong-Luo-Qu-Tong Plaster group

Qi-Zheng-Xiao-Tong Plaster DRUG

for 14 days as two period of treatment, daily 1 time

Qi-Zheng-Xiao-Tong Plaster group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: collaborator
• Shanghai University of Traditional Chinese Medicine: lead
• Suzhou Hospital of Traditional Chinese Medicine: collaborator
• Luoyang Osteopathy hospital of Henan: collaborator
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Liaoning University of Traditional Chinese Medicine: collaborator
• The Second Hospital of Nanjing Medical University: collaborator
• The Fourth Central Hospital of Tianjin: collaborator

Study Sites (1)

Longhua Hospital, Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31234919 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yongjun Wang, Doctor

  Longhua Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuejun Cui, Doctor

CONTACT

021-64385700; 13917715524@139.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: positive control

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 13, 2017
• Study Start: September 12, 2017
• Primary Completion: December 20, 2019
• Study Completion: September 20, 2020
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

CN (1)