Clinical study on chronic subdural hematoma by traditional Chinese medicine.

Not Applicable

• Conditions: Chronic subdural hematoma

• Registration Number: JPRN-jRCTs051180131
• Lead Sponsor: Matsumoto Hiroaki

Brief Summary

Chronic subdural hematoma recurs in 10-33% of patients after surgery, and reoperation or repeated exacerbation of symptoms may lead to deterioration of ADL and serious complications. In this study, we showed that the Japanese traditional medicines Saireito and Goreisan were effective in preventing recurrence in postoperative patients with chronic subdural hematoma.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Study Completion: 2019-11-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence or absence of symptomatic recurrence within 3 months after operation.

Secondary Outcome Measures

Name	Time	Method
Changes in AST,ALT,gamma-GTP