Korean
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)
Medicine 2019-Nov

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.

등록 된 사용자 만 기사를 번역 할 수 있습니다.
로그인 / 가입
링크가 클립 보드에 저장됩니다.
Jungbin Song
Seon-Mi Shin
Hocheol Kim

키워드

요약

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.

페이스 북
페이지에 가입하세요

과학이 뒷받침하는 가장 완벽한 약초 데이터베이스

  • 55 개 언어로 작동
  • 과학이 뒷받침하는 약초 치료제
  • 이미지로 허브 인식
  • 인터랙티브 GPS지도-위치에 허브 태그 지정 (출시 예정)
  • 검색과 관련된 과학 출판물 읽기
  • 효과로 약초 검색
  • 관심사를 정리하고 뉴스 연구, 임상 실험 및 특허를 통해 최신 정보를 확인하세요.

증상이나 질병을 입력하고 도움이 될 수있는 약초에 대해 읽고 약초를 입력하고 사용되는 질병과 증상을 확인합니다.
* 모든 정보는 발표 된 과학 연구를 기반으로합니다.

Google Play badgeApp Store badge