Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062555) titled 'Randomized Double-Blind Trial of a Genistein-Containing Nutritional Supplement for Finger Symptoms in Middle-Aged Women' on Aug. 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Kikkoman NutriCare Japan Co., Ltd.

Condition: Condition - Finger symptoms in middle-aged women Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the exploratory efficacy and safety of a genistein-containing nutritional supplement for finger symptoms, including pain, stiffness, and numbness, in middle-aged women. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants receive a genistein-containing nutritional supplement for 24 weeks. The study product is taken daily according to the specified administration schedule and prescribed daily dose. Interventions/Control_2 - Participants receive a matching placebo without the active ingredient for 24 weeks. The placebo is taken daily according to the same administration schedule and prescribed daily dose as the active supplement.

Eligibility: Age-lower limit - 40 years-old

Gender - Female Key inclusion criteria - Women aged 40 to less than 65 years Participants with self-reported finger pain, stiffness, and/or numbness Participants who provide written informed consent Participants who are able to continuously take the assigned study product or placebo during the study period Key exclusion criteria - Participants with known allergy to soy-derived products Participants with severe systemic disease judged inappropriate for study participation by the investigators Participants currently participating in another clinical trial Participants who are pregnant, breastfeeding, or may become pregnant Participants otherwise judged unsuitable for study participation by the investigators Target Size - 24

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 01 Month 23 Day Date of IRB - 2024 Year 09 Month 20 Day Anticipated trial start date - 2025 Year 02 Month 12 Day Last follow-up date - 2026 Year 02 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070817

Disclaimer: Curated by HT Syndication.