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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03309501|
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : November 9, 2017
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||positive control|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- Visual analogue pain scale [ Time Frame: from baseline to 2 weeks ]Visual Analog Scale /Score ranges 0-10.Higher values represent a worse outcome.
- 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.
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
|Contact: Xuejun Cui, Doctor||021-64385700 ext firstname.lastname@example.org|
|Longhua Hospital, Shanghai University of TCM||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Xuejun Cui, Dr 021-64385700 ext 1309 email@example.com|
|Principal Investigator: Yongjun Wang, Dr|
|Principal Investigator:||Yongjun Wang, Doctor||Longhua Hospital|