Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062657) titled 'Effect of salt-reduction support at community pharmacies on home systolic blood pressure: crossover trial' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - National Hospital Organization Kyoto Medical Center

Condition: Condition - Hypertension Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate whether the provision of low-salt foods and brief pharmacist-led information on salt reduction at community pharmacies improves home systolic blood pressure among patients receiving oral antihypertensive treatment, compared with a control period involving home blood pressure monitoring alone. The study will also assess changes in knowledge, attitudes, and confidence regarding lifestyle behaviors for blood pressure control, as well as step counts and body weight, to examine the feasibility of implementing this blood pressure management support program in community pharmacies. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Sequence AB: During the intervention period, participants replace one meal per day, preferably dinner, with a low-salt food, low-salt soup, and 150 g of rice for 5 days. On the first day, a pharmacist provides brief education on salt reduction using a leaflet for approximately 3 minutes. Participants record morning and evening home blood pressure, body weight, step counts, and meal timing. After a 2-day washout period, participants enter the control period and perform home blood pressure monitoring only for 7 days. Interventions/Control_2 - Sequence BA: During the control period, participants perform home blood pressure monitoring only for the first 7 days. After a 2-day washout period, participants enter the intervention period and replace one meal per day, preferably dinner, with a low-salt food, low-salt soup, and 150 g of rice for 5 days. On the first day, a pharmacist provides brief education on salt reduction using a leaflet for approximately 3 minutes. Participants record morning and evening home blood pressure, body weight, step counts, and meal timing.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adults aged 20 years or older Patients taking oral antihypertensive medication and regularly visiting a participating community pharmacy Patients who measure home blood pressure or are able to perform home blood pressure monitoring during the study period Patients who understand the study explanation and provide written informed consent Key exclusion criteria - Patients who are expected to have difficulty continuing participation during the study period, such as due to relocation Patients requiring strict dietary restrictions, including salt or protein restriction, because of severe cardiac disease, renal disease, or other serious conditions Patients who are pregnant or may be pregnant Patients judged by the principal investigator or study staff to be inappropriate for participation in the study Target Size - 50

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 03 Month 31 Day Date of IRB - 2026 Year 04 Month 30 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070521

Disclaimer: Curated by HT Syndication.