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临床试验/SLCTR/2022/030
SLCTR/2022/030尚未招募未知

Determination of the effects of herbal tea made of Osbeckia octandra on hepatic steatosis in metabolic dysfunction associated fatty liver disease.

未提供0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募

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

入选标准

  • All patients with ultrasonically proven fatty liver disease, who are attending the Liver Clinic of Gastroenterology & Hepatology Department at CNTH-Ragama and NHSL Colombo
  • MAFLD patients diagnosed based on following criteria:
  • ohistological (biopsy), imaging or blood biomarker evidence of hepatic steatosis
  • owith one of the following three criteria,
  • oOverweight/ obesity (BMI ?23 kg/m2 in Asians)
  • oType 2 diabetes mellitus (FBS ?7.0mmol/L (126mg/dL), HbA1C ? 6.5%, OGTT ? 200 mg/dL
  • oEvidence of metabolic dysregulation (at least 2 of the following criteria need to be met)
  • oWaist circumference ?90/80 cm in Asian men and women
  • oBlood pressure ?130/85 mmHg or specific drug treatment
  • oPlasma triglycerides ?150 mg/dl (?1.70 mmol/L) or specific drug treatment
  • oPlasma HDL-cholesterol <40 mg/dl (<1.0 mmol/L) for men and <50 mg/dl (<1.3 mmol/L) for women or specific drug treatment
  • oPrediabetes (i.e., fasting glucose levels 100 to 125 mg/dl [5.6 to 6.9 mmol/L], or 2-hour post-load glucose levels 140 to 199 mg/dl [7.8 to 11.0 mmol] or HbA1c 5.7% to 6.4% [39 to 47 mmol/mol])
  • oHomeostasis model assessment of insulin resistance score ?2.5
  • oPlasma high-sensitivity C-reactive protein level >2 mg/L
  • Age 18–60 years (male and female)

排除标准

  • History of alcohol consumption of ?14 units/week for women and ?21 units/week for men.
  • Patients who have been diagnosed with other known causes of liver disease (HBV and HCV and autoimmune hepatitis)
  • Presence of clinical, radiological, biochemical and or endoscopic evidence of cirrhosis
  • Patients who are on medications for other chronic disease including hypertension, diabetes mellitus and hyperlipidaemia.
  • Any diagnosed malignancy
  • Breast feeding, pregnant, and/or planning for pregnancy in the within one year
  • The patients who are already taking or recently used (within 6 months) herbal preparations or Ayurvedic treatment for any condition.
  • People who are allergic to herbal preparations.

研究者

发起方
未提供

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