Kamisyoyosan's effects on some menopausal symptoms study:KOSMOS Study
- Conditions
- Menopausal disorders
- Registration Number
- JPRN-jRCT1080223160
- Lead Sponsor
- Tsumura & Co.
- Brief Summary
The change in the excitability and irritability score of the NR group was -3.1+-1.7 in the TJ-24 group, which was a significant decrease, but no significant difference was observed between the two groups.In a subgroup analysis, changes in the excitability and irritability score in premenopausal women were significantly greater in the TJ-24 group. The incidence of either adverse drug reactions or adverse events between the two arms and no event was serious.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 53
1) Menopausal disorder patients
2) Patients who had mental manifestation.
3) Patients who had vasomotor sympotms.
4) Agreement to sign an informed consent.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>The change in menopansal symptom (excitement and irritability)
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>The change in menopansal symptom (except excitement and irritability)<br>The change in QO