Menopausal disorders
Conditions
Interventions
investigational material(s)
Generic name etc : TJ-24 (TSUMURA Kamishoyosan Extract Granules)
INN of investigational material : -
Therapeutic category code : 52- Chinese medicines
Dosage and Administra
Sponsors
Tsumura & Co.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Menopausal disorder patients 2) Patients who had mental manifestation. 3) Patients who had vasomotor sympotms. 4) Agreement to sign an informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with an extremely weak gastrointestinal tract 2) Patients with anorexia, nausea and vomiting 3) Patients with severe psychiatric disorder 4) Patinets with serious complications 5) Patients who are decided inadequate by their doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy The change in menopansal symptom (excitement and irritability) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy The change in menopansal symptom (except excitement and irritability) The change in QOL | — |
Countries
Japan
Outcome results
None listed