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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorBeijing Tiantan Hospital

About this trial

A prospective, randomised, double-blind, placebo-controlled, multicentre trial was designed to compare the the incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH of treatment in the HXLS and placebo groups.

Eligibility criteria

Qualifiers

Age between 18 and 90 years and either gender will be included.

Supratentorial, unilateral or bilateral CSDHs will be verified via cranial CT or magnetic resonance imaging (MRI).

Primary hematoma or residual hematoma after burr-hole drainage.

Stable vital signs and neurological deficits are indicated by a Glassgow Coma Scale (GCS) score ≥ 14 and a modified Rankin scale (mRS) score ≤ 2.

Disqualifiers

Unstable vital signs or symptoms of brain herniation, including severe headache, nausea and vomiting, or disturbed consciousness.

Progressive or apparent neurological deficit with a GCS score < 14 or mRS score > 2.

Midline shift > 10 mm on the radiological image.

Previous medication treatment for CSDH.

Trial design

Treatments tested in this trial

  • Chinese Herbal formula HuoXue LiShui
  • Chinese Herbal formula Placebo

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators