A Phase 3 interventional study of Tong-Luo-Qu-Tong Plaster and Qi-Zheng-Xiao-Tong Plaster in Knee Osteoarthritis and Chronic Musculoskeletal Disease, sponsored by Shanghai University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-11-09.
Sponsored by Shanghai University of Traditional Chinese Medicine · Phase 3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Intervention: Tong-Luo-Qu-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses
Drug: Tong-Luo-Qu-Tong Plaster
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.
for 14 days as two period of treatment, daily 1 time
WOMAC scores
Western Ontario and McMaster universities osteoarthritis index, ranges 0-96. Higher values represent a worse outcome.
Time frame: from baseline to 2 weeks
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.
Time frame: from baseline to 2 weeks
Visual analogue pain scale
Visual Analog Scale /Score ranges 0-10.Higher values represent a worse outcome.
Time frame: 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.
Time frame: In 2 weeks
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Shanghai University of Traditional Chinese Medicine