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

Primary Purpose

Knee Osteoarthritis, Chronic Musculoskeletal Disease

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Tong-Luo-Qu-Tong Plaster

Qi-Zheng-Xiao-Tong Plaster

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Randomised Double-blind Controlled trial, Tong-Luo-Qu-Tong Plaster

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Longhua Hospital, Shanghai University of TCMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tong-Luo-Qu-Tong Plaster group

Qi-Zheng-Xiao-Tong Plaster group

Arm Description

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

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

Outcomes

Primary Outcome Measures

WOMAC scores

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

Secondary Outcome Measures

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.

Visual analogue pain scale

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

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.

Full Information

NCT ID

NCT03309501

First Posted

October 10, 2017

Last Updated

November 8, 2017

Sponsor

Shanghai University of Traditional Chinese Medicine

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

1. Study Identification

Unique Protocol Identification Number

NCT03309501

Brief Title

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

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 12, 2017 (Actual)

Primary Completion Date

December 20, 2019 (Anticipated)

Study Completion Date

September 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis, Chronic Musculoskeletal Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

positive control

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tong-Luo-Qu-Tong Plaster group

Arm Type

Experimental

Arm Description

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

Arm Title

Qi-Zheng-Xiao-Tong Plaster group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tong-Luo-Qu-Tong Plaster

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Qi-Zheng-Xiao-Tong Plaster

Intervention Description

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

Primary Outcome Measure Information:

Title

WOMAC scores

Description

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

Time Frame

from baseline to 2 weeks

Secondary Outcome Measure Information:

Title

TCM syndrome quantitative scores

Description

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.

Time Frame

from baseline to 2 weeks

Title

Visual analogue pain scale

Description

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

Time Frame

from baseline to 2 weeks

Title

On effective time of pain relief of drug

Description

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.

Time Frame

In 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xuejun Cui, Doctor

Phone

021-64385700

Ext

1309

13917715524@139.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongjun Wang, Doctor

Organizational Affiliation

Longhua Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Longhua Hospital, Shanghai University of TCM

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xuejun Cui, Dr

Phone

021-64385700

Ext

1309

13917715524@139.com

First Name & Middle Initial & Last Name & Degree

Yongjun Wang, Dr

12. IPD Sharing Statement

Citations:

PubMed Identifier

31234919

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.

Results Reference

derived

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

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