A formulation of Clausena anisata (Willd.) Hook. f. Ex Benth and Cassia sieberiana DC. alleviates the symptoms associated with osteoarthritis: a single-blind, randomised controlled trial of a traditional Ghanaian remedy

Abstract

BackgroundClinical validation of herbal medicinal products is important for their widespread acceptance and application. In this single-blind, randomised controlled trial, a traditional Ghanaian herbal medicine formulation with Clausena anisata (Willd.) Hook. f. ex Benth and Cassia sieberiana DC. as ingredients was evaluated for its safety and effectiveness in the management of patients with osteoarthritis. The formulation for the purposes of this study was labelled with the code GC-500.MethodsA total of 57 participants were randomly assigned to receive either this herbal remedy, GC-500, or the control treatment of diclofenac. Subjects were then followed up for a period of 8 weeks using a modified Graded Chronic Pain Scale (GCPS) for their efficacy assessments. The control treatment comprised 13 subjects and the GC-500 group 44 subjects.ResultsUpon completion of the study, 28 (63.63%) subjects in the GC-500 group attained the primary outcome, (GCPS of Grade 0) compared to 5 (38.46%) subjects in the control group. Improvement in disease indicators such as characteristic pain intensity, disability score and disability days was comparable between the GC-500 and diclofenac. Intensity of pain reduced after 8 weeks of treatment; disability score and disability days also declined indicating an improvement in the quality of life of subjects. GC-500 was also shown to be safe for human use.ConclusionThe herbal medicine formulation GC-500, provides a credible treatment option for managing the pain associated with osteoarthritis.Trial registrationThis study was retrospectively registered with the Pan-African Trial registry with a Trial ID: PACTR201909643671755 on 25th September, 2019 at https://pactr.samrc.ac.za/Search.aspx