Climacteric symptom
Conditions
Interventions
Kamishoyosan Usually, in adults, administer orally at 7.5 g/day in two to three divided doses before or between meals. Adjust the dose as needed according to the age, body weight and symptoms of pat
Sponsors
University hospital, Hirosaki University School of Medicine Dept. of Obstetrics & Gynecology
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients who are diagnosed with climacteric symptom 2)Females with at least 6 months after the last menstruation, or, if it is unknown due to hysterectomy when menopause occurs, females at 60 years or younger whose FSH was 40 mIU/ml or higher within the last 6 months 3)Patients with SDS raw scores between 40 points and less than 70 points 4)Inpatient/Outpatient status: Outpatient 5)Patients who gives written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients with Major Depressive Episode according to the DSM-IV diagnostic criteria 2)Patients with a history of psychiatric disease 3)Patients who have undergone oophorectomy within the last 6 months 4)Patients who have taken neurological drugs (antianxiety drugs, sedative hypnotics, antiepileptic drugs, analeptics/psychostimulants, antiparkinson drugs, psychoneurological drugs, autonomic drugs (benzodiazepines, and antidepressants), and/or Kampo medicine within 2 weeks before enrollment 5)Patients who have used estrogens and gestagens within 4 weeks before enrollment 6)Patients with serious complications (e.g., hepatic, renal, cardiac, pulmonary, hematological, or metabolic diseases) 7)Patients with a history of drug allergy 8)Patients who have been treated with any investigational drug or will participate in a clinical trial within 4 weeks before enrollment 9)Patients for whom paroxetine is contraindicated 10)Other patients who are assessed to be inappropriate for study participation by the investigator, or other relevant persons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of time profile of anxiety state, depressive state, and symptoms of climacteric symptom with questionnaires (STAI, SDS, and Questionnaire for Assessment of Climacteric Symptoms) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical pharmacological evaluation (changes in GABA and three fractions of catecholamine) Drug safety | — |
Countries
Japan
Contacts
Public ContactTsuyoshi Higuchi
University hospital, Hirosaki University School of Medicine Dept. Of Obstetrics & Gynecology
Outcome results
None listed