Efficacy and Safety of Chinese Herbal Medicine HuoXue LiShui Formula for Chronic Subdural Hematoma (CHARM): Study Protocol for a Multicenter Randomized Controlled Trial

Abstract

Background Chronic subdural hematoma (CSDH) is one of the most common neurosurgical conditions and occurs mainly in elderly individuals. Surgical evacuation is usually effective for this pathology but commonly carries significant risks, especially in patients with multiple comorbidities. Therefore, interest in nonsurgical treatment with medications such as tranexamic acid, atorvastatin, and dexamethasone is increasing. However, the efficacy of all these medications is still uncertain in patients with CSDH. According to the literature, the operative rate at 24 weeks is 5–33%. In our retrospective study, the Chinese herbal medicine HuoXue LiShui (HXLS) formula significantly reduced the necessity for surgery in patients with CSDH. The results demonstrated that HXLS can achieve low operative rates and good outcomes. Methods/design This is a prospective, multicenter, double-blinded, blinded endpoint, randomized controlled trial designed to include 160 participants 18–90 years of age presenting with CSDH verified via computed tomography or magnetic resonance imaging. The participants will be randomly allocated to receive HXLS granules (treatment group) or placebo (control group) after enrollment two times daily for 8 weeks. The primary endpoint will be the incidence of hematoma progression requiring surgery or recurrence requiring reoperation; the secondary outcomes will include CSDH volume, thickness, neurological outcome, cognitive function, performance in activities of daily living, and quality of life at 24 weeks. Discussion This trial will validate the efficacy and safety of the Chinese herbal medicine HXLS formula in reducing operative rates, improving clinical outcomes in patients with CSDH, and improving nonsurgical management. Trial registration This trial was registered at Clinicaltrials.gov with NCT06427980 on August 17, 2024. (https://www.clinicaltrials.gov/ct2/show/study/NCT06427980.)