Efficacy and Safety of Sahastara Remedy Extract Capsule in Primary Knee Osteoarthritis: A Randomized Double-Blinded Active-Controlled Trial

Abstract

Sahastara (SHT) remedy is a Thai traditional medicine described in the Thai National List of Essential Medicine (NLEM) for the relief of muscle pain. The purpose of this study was to investigate the efficacy and safety of SHT remedy extract capsule for treating primary OA. A phase 2, double-blind, randomized, and controlled trial study was used to determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treatment of knee OA. The outcome of reduce pain was measured from VAS, 100 meter time walk, and the WOMAC score of day 14 and day 28 which should reduce significantly when compared with day 0 and should be equal with or better than diclofenac. Blood pressure and blood chemistry values at day 14 and day 28 did not change when compared with day 0. The results found that SHT remedy ethanolic extract capsule can reduce all OA knee scores at day 14 and day 28 significantly when compared with day 0 and also no significant difference with diclofenac ( $P>0.05$ ). The SHT also showed safety values on blood pressure and blood chemistry. The SHT was observed that it had no serious side effect. The results of this study are the first report of using the SHT ethanolic extract capsule in the treatment of primary osteoarthritis of the knee. It can be recommended as an anti-inflammatory herbal drug for reducing pain in knee osteoarthritis patients.