Kampo (saireito) for Immediate cRaniotomy Surgical headaCHE

JRCT ID: jRCTs031220605

Registered date:01/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patient undergoing craniotomy
• Date of first enrollment: 03/03/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Medication: Three packets of Saireito per day, divided into three doses, are administered orally before or between meals. The administration period is one week before and one week after surgery, for a total of 2 weeks.

Outcome(s)

• Primary Outcome: Total number of analgesics used in 9-15 days (postoperative day 1-7)

Secondary Outcome

Day 9 (postoperative day 1) (VAS, temporalis muscle swelling rate, WBC, CK, IL-6, IL-8, IL-10),
Day 15 (postoperative day 7) (VAS, QoR40, pain level by Pain vision)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1) Patients undergoing craniotomy with an anterior temporal craniotomy
2) Patients who are at least 18 years old and less than 75 years old
3) Patients who have been fully informed and understood about the study, and have given written informed consent

Exclude criteria

1) Patients using steroids or interleukin inhibitors
2) Female who are pregnant or may become pregnant
3) Lactating female
4) Patients who have received any other study drug or investigational drug within 3 months prior
5) Other patients who are deemed inappropriate as subjects by the investigators

Related Information

• Primary Sponsor: Ito Yoshiro
• Source(s) of Monetary Support: University of Tsukuba Hospital