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Knee OsteoarthritisPhase 3NCT03309501

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

A Phase 3 study testing Tong-Luo-Qu-Tong Plaster and Qi-Zheng-Xiao-Tong Plaster in people with Knee Osteoarthritis and Chronic Musculoskeletal Disease, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
Tong-Luo-Qu-Tong Plaster and Qi-Zheng-Xiao-Tong Plaster
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
1 siteChina
Study dates
12 Sep 2017to 20 Sep 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Xuejun Cui, Doctor contact

021-64385700 ext. 1309

13917715524@139.com

China1 site, 1 recruiting

  • Longhua Hospital, Shanghai University of TCM

    Shanghai, Shanghai Municipality, 200032

    Xuejun Cui, Dr, 021-64385700 ext. 1309, 13917715524@139.com

    Yongjun Wang, Dr

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Tong-Luo-Qu-Tong Plaster, Qi-Zheng-Xiao-Tong Plaster
Keywords
Knee osteoarthritis, Randomised Double-blind Controlled trial, Tong-Luo-Qu-Tong Plaster
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tong-Luo-Qu-Tong PlasterDrug

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

  • Qi-Zheng-Xiao-Tong PlasterDrug

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

Study groups in NCT03309501
Study groupRoleWhat they receive
Tong-Luo-Qu-Tong Plaster groupExperimentalIntervention: Tong-Luo-Qu-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses
Receives: Drug: Tong-Luo-Qu-Tong Plaster
Qi-Zheng-Xiao-Tong Plaster groupActive comparatorIntervention: Qi-Zheng-Xiao-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses
Receives: Drug: Qi-Zheng-Xiao-Tong Plaster

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WOMAC scores

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

    Measured: from baseline to 2 weeks

Secondary outcomes (3)

  1. 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.

    Measured: from baseline to 2 weeks

  2. Visual analogue pain scale

    Visual Analog Scale /Score ranges 0-10.Higher values represent a worse outcome.

    Measured: from baseline to 2 weeks

  3. 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.

    Measured: In 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2017
  2. Study start12 Sep 2017
  3. Primary completion20 Dec 2019 (estimated)
  4. Study completion20 Sep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
positive control
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03309501
Sponsor's protocol ID
TLQT Plaster
Status last verified
Nov 2017
First submitted
10 Oct 2017
Last updated
9 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 31234919

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tong-Luo-Qu-Tong Plaster and Qi-Zheng-Xiao-Tong Plaster in people with Knee Osteoarthritis and Chronic Musculoskeletal Disease, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xuejun Cui, Doctor (021-64385700 ext. 1309, 13917715524@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC scores (time frame: from baseline to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03309501, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017; AzTrials last refreshed its copy on 3 Nov 2026.

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