Clinical study on chronic subdural hematoma by traditional Chinese medicine.

JRCT ID: jRCTs051180131

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic subdural hematoma
• Date of first enrollment: 02/04/2017
• Target sample size: 300
• Study type: Interventional

Intervention(s)

Arm Goreisan:As long as Kracie Goreisan-Ryo Extract Fine Granules (6.0 g / day) given 3 months after the operation.
Arm Saireito:As long as Kracie Saireito Extract Fine Granules (8.1 g / day) given 3 months after the operation.

Outcome(s)

• Primary Outcome: Presence or absence of symptomatic recurrence within 3 months after operation.
• Secondary Outcome: Changes in AST,ALT,gamma-GTP

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with chronic subdural hematoma.
2. Patient who is an initial case.
3. Patients who are over 20 years old.

Exclude criteria

1.Patients who have difficulty in taking traditional Chinese medicine.
2.Patients who show marked decline in cognitive function and have difficulty in compliance with medication compliance (such as those with an MMSE score of 23 or less)
3. Asymptomatic and bilateral chronic subdural bloodline patients
4. Patients with severe renal dysfunction (creatinine clearance less than 30 mL / min etc.)
5.Patients who could not carry out prescribed surgery
6.Patients who have allergies of traditional Chinese medicine and herbal medicines (such as those with a history of hypokalemia)
7.Patients who are considered inappropriate for inclusion in research

Related Information

• Primary Sponsor: Matsumoto Hiroaki
• Source(s) of Monetary Support: Kracie Pharmaceutical, Ltd.