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Efficacy and Safety of Chinese Herbal Formula HuoXue LiShui for Chronic Subdural Hematoma — CHARM  

Chronic Subdural Hematoma Clinical Trial

Official title:
Efficacy and Safety of Chinese Herbal Formula HuoXue LiShui for Chronic Subdural Hematoma: a A Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail

Clinical Trial Summary

A prospective, randomized, double-blinded, placebo-controlled, multicenter trail is designed to compare differences of operation rate and clinical outcome from treatment up to 24 weeks between HXLS group and placebo group.

Clinical Trial Description

The CHARM trial is a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical study. The trial aims to investigate the efficacy of Chinese herbal formula HXLS as an addition to a primary conservative treatment of CSDH, in an effort to prevent surgery. We hypothesize that compared with placebo, Chinese herbal formula HXLS reduces operation rates and improves clinical outcomes at 24 weeks in patients with CSDH. Consequently, the defined null hypothesis will be that there is no difference between the groups. In total, 160 patients will be randomly assigned to the HXLS group and placebo group at 1:1 ratio. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06427980
Study type Interventional
Source Beijing Tiantan Hospital
Contact Liang Wu, M.D.
Phone 15001333582
Email wuliang@bjtth.org
Status Not yet recruiting
Phase N/A
Start date June 1, 2024
Completion date February 28, 2025
View Details
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