Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062227) titled 'A pilot study on the efficacy of Hachimijiogan for pre-frailty/frailty accompanied by nocturia' on July 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - University of Toayam

Condition: Condition - pre-frailty/frailty Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the efficacy of Hachimijiogan in treating frailty and pre-frailty in patients who experience two or more nighttime urination episodes and have a JFS score of 4 or higher. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Hachimijiogan

Eligibility: Age-lower limit - 60 years-old

Gender - Male and Female Key inclusion criteria - 1) Patients receiving treatment at Toyama University Hospital or Hida City Hospital 2) Men and women aged 60 or older but under 85 at the time of obtaining informed consent 3) Patients who have been taking any of the following oral medications for the past two months anticholinergics, beta 3 agonists, or alpha 1 blockers and who experience two or more episodes of nocturia 4) Japan Frailty Scale (JFS) score of 4 or higher 5) Patients capable of walking 5 meters or more 6) Patients who have provided written informed consent Key exclusion criteria - 1) Patients taking Japanese taraditional(Kampo) medicine 2) Patients who regularly consume health functional foods that may affect the study at least three times a week and are unable to discontinue their use starting three weeks before the start of the study 3) Patients who have changed the dosage or type of any of the following Western medications within the past two months, which may worsen frequent urination:no specific underlying medical conditions required a) Diuretics b) SGLT2 inhibitors c) Cholinergic agents d) PDE5 inhibitors 4) Patients with renal impairment (eGFR = 100 IU/L) 6) Patients with severely impaired walking ability, such as those who require a cane or wheelchair to walk 7) Patients with a sensitive gastrointestinal tract who are prone to diarrhea 8) Patients deemed unsuitable for participation in this study for other reasons, such as having serious complications Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 01 Day Date of IRB - 2026 Year 06 Month 10 Day Anticipated trial start date - 2026 Year 07 Month 22 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071212

Disclaimer: Curated by HT Syndication.