Patients with lymphedema
Conditions
Interventions
TSUMURA Hainosankyuto Extract Granules for Ethical Use plus oral antibiotics for two weeks
oral antibiotics for two weeks
Sponsors
Hokkaido University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients with lymphedema 2)Patients diagnosed grade 2 and more in lymphedema staging according to International Society of Lymphedema (ISL) 3)Patients with a first episode of purulence or who relapsed after over a year 4)Patients within 3 days after the onset of purulence 5)20-75 years of age 6)Sex: Female 7)Outpatient 8)Patients with written consent
Exclusion criteria
Exclusion criteria: 1)Patients with aldosteronism, myopathy and hypokalemia 2)Patients who were prescribed Kampo medicine within 4 weeks before entry 3)Patients who were prescribed an adrenocortical hormonic agent or an anti-allergic agent 4)Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders) 5)Patients with recurrent or metastasized cancer 6)Pregnant patients, breast-feeding patients or patients hoping to become pregnant 7)Patients considered inappropriate by the study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of days to clear the symptoms of purulence | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)The severity of the symptoms of purulence 2)The body temperature 3)QOL questionnaire 4)The circumference of the region of lymphedema (the affected side) 5)Immunologic test [Measuring NK cell activity, balance between Th1 and Th2, and cytokine (TNF-alpha, IL-12)] | — |
Countries
Japan
Contacts
Public ContactNoriko Kobayashi
Hokkaido University Hospital Gynecology
Outcome results
None listed