Efficacy and Safety of Tongning Gel for Knee Osteoarthritis: A Multicentre, Randomized, Double-Blinded, Parallel, Placebo-Controlled, Clinical Trial

Objective. To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo-controlled (PC) for knee osteoarthritis (KOA). Methods. A multicentre, randomized, double-blinded, parallel, placebo-controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 p...

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Published in:Evidence-based complementary and alternative medicine 2020, Vol.2020 (2020), p.1-9
Main Authors: Yin, Hong, Chen, Yong Qiang, Sun, Qing, Xie, Li Ming, Yuan, Wei An, Zheng, Yuxin, Zhan, Hong Sheng, Shen, Lin, Lu, Min, He, Cheng Jian, Yang, Jun Xing, Liu, Wen Gang, Ge, Ji Rong, Shen, Zhibi, Zhao, Ye, Li, Zhi Bin
Format: Article
Language:English
Subjects:
Arthritis
Blood
Chinese medicine
Clinical trials
Comparative analysis
Efficiency
Hospitals
Investment analysis
Knee
Medical research
Nonsteroidal anti-inflammatory drugs
Osteoarthritis
Pain
Patients
Pharmaceuticals
Physical therapy
Product development
Safety
Side effects
Statistical analysis
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Summary:Objective. To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo-controlled (PC) for knee osteoarthritis (KOA). Methods. A multicentre, randomized, double-blinded, parallel, placebo-controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug. Patients were randomized to receive TNG or PC applied to knee skin at 3g per time, 2 times per day, which lasted for 3 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was used to evaluate the primary efficacy of TNG and WOMAC stiffness and physical function and total scores were used to evaluate the secondary efficacy of TNG. All participants who received at least one dose of study drug were included in the safety analysis. This trial has been registered in Chinese Clinical Trial Registry (no. CTR20131276). Results. Primary efficiency outcome: there were significant differences in the decreased value of WOMAC pain score between two groups (P
ISSN:1741-427X
1741-4288
DOI:10.1155/2020/8707256