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临床试验/KCT0009398
KCT0009398招募中Unknown

A 12-week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Kaempferia parviflora extract on Body Fat

Dong-A University Hospital0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
20(Year) 至 65(Year)(—)
性别
All

入选标准

  • 1) More than 20 years old
  • 2) The body mass index (BMI) is 25 kg/m2 or more than 25 kg/m 2 or less than 30 kg/m 2
  • 3) Before the human application experience of this human application test before the human application test begins, and in writing agreements

排除标准

  • 1) A person currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary systems, kidney and urinary systems, nervous system, psychiatric, infectious diseases, and malignancies (but can participate in the test at the discretion of the tester considering the subject's condition)
  • 2) A person who has a history of surgery through general anesthesia within six months from the first visit ( Provided, That in the case of obesity surgery, within one year)
  • 3) A person who has used subcutaneous injections (heparin, insulin) within one year from visit 1
  • 4) Those who used the following drugs within one month (30 days) of visit - Obesity drugs (eating suppression, fat absorption inhibitors, GLP-1 receptor agonists, etc.) - Psychiatric drugs such as depression and schizophrenia - Beta blockers, diuretics, female hormones, male hormones, adrenal cortical hormones, thyroid hormones, immunosuppressants, proton pump inhibitors
  • 5) Those who use the following health functional foods, etc. within three months of visit - Health functional foods that improve hyperlipidemia drugs, blood lipids and cholesterol {Omega 3 (maintained with EPA and DHA), ovarian harmonic maltodextrin, maintained with gamma-linolenic acid, lecithin, plant cholesterol, etc.} - Health functional foods/supplements for weight control purposes, herbal medicines, and weight control preparation foods
  • 6) Uncontrolled hypertension patients (measured after systolic blood pressure of 140 mmHg or diastolic blood pressure of 90 mmHg or more, test subjects of 10 minutes of stability)
  • 7) Diabetes patients with fasting blood sugar of 126 mg/dL or more or taking antidiabetic medications (such as oral hypoglycemic drugs)
  • 8) Any person whose TSH is out of the normal range of the implementer
  • 9) Those with eGFR less than 60 mL/min/1.73 m2
  • 10) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the implementation engine
  • 11) Alcohol drinkers exceeding the appropriate amount [male = 40 g/day, female = 20 g/day (WHO's daily alcohol intake standard)]
  • 12) Excessive smokers (=20 cigarettes/day)
  • 13) A person who is deemed unable to exercise due to musculoskeletal disorders
  • 14) A person who has changed his/her weight by 10% or more or 5 kg or more within 3 months from visit 1
  • 15) A person who participated in a commercial obesity program within three months from the first visit
  • 16) A person who has given birth within 6 months as of visit 1, is pregnant, is nursing, or is planning to become pregnant during the self-application test period
  • 17) A person who has a problem with the intake of food for human application tests due to severe gastrointestinal disorders
  • 18) A person who is sensitive or allergic to food ingredients for this human application test
  • 19) A person who has metal in the body due to surgery, etc
  • 20) A person who has participated in other interventional clinical trials (including human application tests) within three months of the visit, or who plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
  • 21) A person who finds the tester inappropriate due to other reasons

研究者

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