The efficacy and safety of Xianling Gubao capsules in the treatment of knee osteoarthritis: A protocol for a randomized, double-blind, controlled trial

• Published in: Medicine (Baltimore) 2021-09, Vol.100 (36), p.e27086-e27086
• Main Authors: Wu, Jinfeng, Li, Wenxu, Ye, Baoqing, Yao, Yicun
• Format: Article
• Language: English
• Subjects: Administration, Oral; Double-Blind Method; Drugs, Chinese Herbal - administration & dosage; Drugs, Chinese Herbal - therapeutic use; Humans; Osteoarthritis, Knee - drug therapy; Phytotherapy; Randomized Controlled Trials as Topic; Study Protocol Clinical Trial
• ISSN: 0025-7974; 1536-5964; 1536-5964
• DOI: 10.1097/MD.0000000000027086

Knee osteoarthritis (KOA) is a chronic degenerative joint disease, which is the most common type of osteoarthritis. The clinical manifestations are pain, swelling, and dysfunction of the knee joint, which seriously reduces the quality of life of patients and causes a huge social burden. At present, western medicine mainly focuses on symptomatic treatment, such as anti-inflammatory and pain relief, joint cavity injection, joint replacement, etc. The curative effect has certain limitations. Xianling Gubao capsule has some advantages in the treatment of KOA, but it lacks high-quality clinical research to verify it. Therefore, the purpose of this study is to evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of KOA. A randomized, double-blind, double-simulation, parallel controlled trial design was used to study the efficacy and safety of Xianling Gubao capsules in the treatment of KOA. The patients were randomly divided into a treatment group and the control group according to 1:1. The treatment group: Xianling Gubao capsule + glucosamine hydrochloride capsule simulation agent treatment; the control group: glucosamine hydrochloride capsule + Xianling Gubao capsule simulation agent treatment. Both groups received standard treatment for 8 weeks and followed up for 30 days. And at the same time, pay attention to its efficacy and safety indicators. Observation indicators include: the western Ontario and McMaster universities osteoarthritis index, hospital for special surgery knee score, liver and kidney function, adverse reactions, etc. Data analysis was performed using SPSS 25.0 software. This study will evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of KOA. The results of this experiment will provide evidence support for Xianling Gubao capsule in the treatment of KOA. OSF Registration number: DOI 10.17605/OSF.IO/ERM9C.