Efficacy and safety of HT048 and HT077 for body fat and weight loss in overweight adults: A study protocol for a double-blind, randomized, placebo-controlled trial.
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The prevalence of excessive body weight has rapidly increased worldwide over the past decades; however, medications are intended for moderately and severely obese patients and are associated with side effects. As an alternative approach, the use of traditional herbal medicines has gained increasing popularity among overweight individuals in recent years in East Asia. HT048 is an herbal extract of Citrus unshiu and Crataegus pinnatifida, and HT077 is an herbal extract of Nelumbo nucifera and Prunus persica. These 4 herbs have been used widely for body weight reduction in China and Korea. The aims of this trial are to investigate whether HT048 and HT077 are effective at reducing body fat and weight in overweight adults, and to determine the safety of HT048 and HT077.A double-blind, randomized, placebo-controlled, 3-arm parallel group trial will be conducted in adults with a body mass index (BMI) of 25 to <30 kg/m. A total of 120 eligible participants will be randomized in a 1:1:1 ratio to receive either HT048 (1000 mg), HT077 (400 mg), or matching placebo twice daily for 12 weeks, and will be monitored for an additional 4-week follow-up period after the treatment. All participants will be assessed for efficacy and safety of the investigational product at baseline and weeks 4, 8, 12, and 16. The primary endpoint is the change in body fat mass and percent body fat measured by dual-energy X-ray absorptiometry at week 12 from the baseline. The secondary efficacy variables are abdominal fat area measured by computed tomography, body fat mass and percent body fat measured by bioelectrical impedance analysis, body weight, BMI, and serum lipids and adipocytokines concentrations. Safety will be evaluated on the basis of reported adverse events, abnormal laboratory results, vital signs, and physical examination findings.This is a first-in-human trial of HT048 and HT077 to assess the efficacy and safety in overweight subjects. The results will provide high-quality evidence of the therapeutic benefits of HT048 and HT077 for weight management and the prevention of obesity.Korean Clinical Research Information Service (KCT0004271) Registered September 2, 2019.
کاملترین پایگاه داده گیاهان دارویی با پشتیبانی علمی
به 55 زبان کار می کند
درمان های گیاهی با پشتوانه علم
شناسایی گیاهان توسط تصویر
نقشه GPS تعاملی - گیاهان را در مکان نشان دهید (به زودی)
انتشارات علمی مربوط به جستجوی خود را بخوانید
گیاهان دارویی را با توجه به اثرات آنها جستجو کنید
علایق خود را سازماندهی کنید و با تحقیقات اخبار ، آزمایشات بالینی و حق ثبت اختراع در جریان باشید
علامت یا بیماری را تایپ کنید و در مورد گیاهانی که ممکن است به شما کمک کنند ، بخوانید ، یک گیاه تایپ کنید و بیماری ها و علائمی را که در برابر آن استفاده می شود ، ببینید. * کلیه اطلاعات براساس تحقیقات علمی منتشر شده است