ISRCTN13677132已完成未知
The effect of Taeeumjowui-tang on overweight or obesity with metabolic syndrome risk factors in Taeeum-in constitution diagnosed by SCAT (Sasang constitutional Analysis Tool): a non-randomised trial
Cheonan Oriental Hospital of Daejeon University0 个研究点目标入组 206 人开始时间: 2019年1月30日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 206
研究概览
简要总结
2021 Results article in https://doi.org/10.3390/app11188741 (added 20/09/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged between 19 and 64.
- •2. Diagnosed by SCAT (Sasang Constitutional Analysis Tool) as a Taeum type person (Taeum-in).
- •3. BMI of 23 or more
- •4. Meet the criteria of waist circumference, and one or more other metabolic syndrome criteria.
- •5. Blood pressure, diabetes, and hyperlipidemia are controlled stably so do not need additional medical prescriptions.
- •6. Able to communicate with researchers and are able to follow the test compliance.
排除标准
- •1. Meet the following criteria
- •1.1. HbA1c 8.5% or more
- •1.2. Fasting triglyceride : TG = 400
- •1.3. LDL-chol. = 190
- •1.4. Blood pressure =160/100mmHg
- •2. History of severe renal impairment (renal failure, nephrotic syndrome, glomerular disease), dialysis history, or Cr level more than twice the normal upper limit.
- •3. History of severe liver disease (cirrhosis, liver cancer), or AST or ALT greater than 2.5 times the normal level.
- •4. Acute phase or urgent angina pectoris, myocardial infarction, stroke, cardiac or cerebrovascular disease.
- •5. Gastrointestinal problems(anorexia, nausea, vomiting, etc.) unlikely to be able to participate under the researcher’s judgement.
- •6. Those who have participated in other interventional clinical trials within the last 3 months.
- •7) Artificial weight loss of more than 10% of the total weight within 6 weeks.
- •8) Those with neuropsychiatric disorders.
- •9) Those with excessive alcohol consumption (more than 14 bottles per week)
- •10) Allergic to test drug ingredients
- •11) Those who plan to participate in other clinical trials during the course of this trial.
- •12) Currently taking medication for hyperthyroidism, or TSH level more than 1.5 times the normal upper limit.
- •13. Diagnosed with malignant tumor or received chemotherapy within 5 years.
- •14. Those who have taken the following medications within 3 months:
- •14.1. Ephedrine
- •14.2. MAO inhibitors
- •14.3. Thyroid medications (thyroxine, lyothionine)
- •14.4. Catecholamines (epinephrine, isoprenaline)
- •14.5. Xanthines (theophylline, dipropyline).
- •15. Changes in medical prescriptions for blood pressure, diabetes, hyperlipidemia, obesity within 3 months.
- •16. Other serious medical conditions or symptoms unlikely to be able to participate under the researcher’s judgement.
- •17. Hidrosis
- •18. Excessive weakness, or in the aftermath of a disease.
- •19. Severe urinary disorders
- •20. Genetic problems such has galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •21. Those who are expected to have dietary changes during the clinical trial
- •22. Pregnant or the possibility of pregnancy, or nursing mother.
- •23. Those who have a history of elevated blood glucose by taking ephedrine
- •24. Those who have taken drugs that can affect body weight such as appetite suppressants, laxatives (without prescription) or oral steroids, thyroid hormones, amphetamines, ciproheptadine, phenodiazines, or drugs that affect absorption or metabolism within 3 months.
- •25. Those who have undergone surgical surgery for weight loss such as gastroplasty.
研究者
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