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Bichedam, a company specializing in natural product-based pharmaceuticals, announced on the 8th that it has initiated a human clinical study to evaluate the efficacy and safety of its health functional food, G Care for Healthy Blood Circulation, in adults experiencing Nocturnal Leg Cramps (NLC).
The study is designed as a multicenter, single-arm, prospective clinical trial and is being conducted at Kyung Hee University Korean Medicine Hospital (Principal Investigator: Professor Seung-Won Kwon) and Wonkwang University Korean Medicine Hospital (Principal Investigator: Professor Jeong-Tae Lim).
Participants aged 40 years or older who have experienced leg muscle cramps during sleep at least twice per week over the previous two weeks will consume G Care for four weeks. Researchers will evaluate the frequency of leg cramps, duration, pain intensity, and sleep-related indicators to generate preliminary data for a subsequent randomized controlled trial (RCT).
The primary endpoint of the study is the weekly frequency of nocturnal leg cramps. Secondary endpoints include cramp duration, pain severity measured by the Numeric Rating Scale (NRS), and insomnia severity assessed using the Insomnia Severity Index (ISI).
According to the Clinical Research Information Service (CRIS) registry, the study aims to enroll 30 participants, and recruitment is currently underway. Enrollment of the first participant began in late February 2026, while data collection and study completion are scheduled for late December 2026.
A Bichedam representative stated, “This study is a preliminary investigation designed to assess the applicability of the product and the appropriateness of the evaluation endpoints in adults experiencing nocturnal leg cramps. The findings are expected to provide valuable data for the design of future randomized controlled trials.”
Source: http://m.yakup.com/news/?mode=view&cat=12&cat2=121&cat3=0&nid=325763
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