Tokyo, Sept. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062952) titled 'Characterization of Kampo Medicine Use for Menopausal Symptoms: A Study Using Web-Based Surveys and Claims Databases' on Sept. 16.

Study Type: Observational

Primary Sponsor: Institute - Kracie, Ltd.

Condition: Condition - Menopausal Symptoms Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to investigate the symptom specific efficacy rates of Kampo medicines prescribed for menopausal disorders using data from Pep Up questionnaires, medical claim records ,hereinafter referred to as receipt data, and health checkups and to clarify which symptoms each prescription effectively addresses. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 40 years-old

Gender - Female Key inclusion criteria - Individuals who are members of a health insurance association during the period from October 1, 2026, to December 31, 2026. Individuals who indicated that they had experienced menopausal symptoms within the past six months in the Pep Up questionnaire. Individuals with a diagnosis of a condition associated with menopausal symptoms in medical claim data from the past six months, and who were prescribed Kampo medicine, HRT, or psychotropic medication within the same claim. Key exclusion criteria - The following groups are defined as the target populations in accordance with the research proposal. Prescriptions for two or more agents from the categories of Kampo medicines, HRT, and psychotropic drugs are present in medical claim data from the past six months. However, for HRT, the prescription of two or more agents within the same category is permitted; for psychotropic drugs, the prescription of two or more agents within the respective therapeutic classes of hypnotics/sedatives, anxiolytics, antidepressants, and mood stabilizers is permitted. Target Size - 1000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 06 Day Date of IRB - 2026 Year 08 Month 28 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071998

Disclaimer: Curated by HT Syndication.