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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031220605

Registered date:01/02/2023

Kampo (saireito) for Immediate cRaniotomy Surgical headaCHE

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPatient undergoing craniotomy
Date of first enrollment03/03/2023
Target sample size40
Countries of recruitment
Study typeInterventional
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 OutcomeTotal number of analgesics used in 9-15 days (postoperative day 1-7)
Secondary OutcomeDay 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
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Yoshiro Ito
Address 2-1-1 Amakubo, Tsukuba, Ibaraki, Japan Ibaraki Japan 305-8576
Telephone +81-29-853-3220
E-mail yoshiro@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital
Scientific contact
Name Yoshiro Ito
Address 2-1-1 Amakubo, Tsukuba, Ibaraki, Japan Ibaraki Japan 305-8576
Telephone +81-29-853-3220
E-mail yoshiro@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital