Efficacy and Safety of Justicia gendarussa Burm.f. Medicated Spray and Topical Diclofenac Spray for the Treatment of Mild to Moderate Soft Tissue Injury: A Randomized Double-blinded Controlled Trial

Abstract

Kraduk Kai Dam (Justicia gendarussa Burm.f.) has been used in folk medicine by pounding the leaves with rice whisky and using a poultice to treat muscle pain, bruises, and joint pain. The purpose of this study was to evaluate the efficacy and safety of J. gendarussa medicated spray (JGS) in comparison with that of diclofenac spray (DFS) to treat patients with mild to moderate soft tissue injury. A randomized double-blinded controlled trial was performed in the Orthopedic Surgery Department of Chao Phya Abhaibhubejhr Hospital, Prachin Buri province, Thailand. Patients aged 15–70 years were randomly assigned to receive either two puffs of JGS or DFS thrice daily for seven days. The patients’ decreases in rest pain and swelling were considered primary outcomes, while the use of pain medication, patients’ global assessment, and reported adverse events were secondary outcomes. The results showed that there were no differences in baseline characteristics between the two groups. At the end of the study, the pain scores in the JGS and DFS groups were not different (mean difference VAS = -0.13, 95%CI -0.81, 0.56; p = 0.68); the reductions in swelling of the JGS and DFS groups were not differentt (risk ratio = 0.988, 95%CI 0.66, 1.48; p = 0.951); the amounts of paracetamol given to the patients were not different between the two groups (p = 0.194); and the skin irritation was not statistically different in both groups, i.e. 8.3% and 6.38% of the patients treated with JGS and DFS (p > 0.05), respectively.  In summary, the efficacy and safety of JGS to treat mild to moderate tissue injuries were comparable to those of DFS.