ITMCTR2200006417尚未招募1 期
Efficacy, Safety and Mechanism of Modified Xianyaoyin in Patients with Mild to Moderate Hypertriglyceridemia: A Study Protocol for a Multicenter and Randomized Controlled Trial
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(1)Aged from 18 to 65 years old.
- •(2)1.7=TG<5.7mmol/l, LDL-C<4.9mmol/l, TC<7.2mmol/l.
- •(3)Meet the diagnostic criteria of TCM syndrome of phlegm and blood stasis based on the Guiding Principles for Clinical Research of New Traditional Chinese Medicine (2002).
- •Main symptoms: obesity, heaviness of the head, vomiting of phlegm and saliva, numbness and lassitude of limbs, and chest distress.
- •Secondary symptoms: palpitation, insomnia, anorexia and relentlessness.
- •Tongue & pulse: enlarged tongue with slippery/slimy coating, ecchymosis and petechia. Wiry or rough pulse.
- •Patients with 1 main symptom / 2 secondary symptoms and above tongue and pulse can be diagnosed as phlegm and blood stasis.
- •(4)Inform consent.
排除标准
- •(1)Taking other drugs or measures with triglyceride-lowering effect within 3 months, including food supplements and additives.
- •(2)Secondary hypertriglyceridemia, drug-induced hypertriglyceridemia, homozygous hypercholesterolemia.
- •(3)Suspected allergy to the test drug or any of its components.
- •(4)Alanine aminotransferase(ALT) and / or aspartate aminotransferase(AST) = 3 times of the upper limit of normal(ULN) and creatinine(CREA) = 1.5×ULN.
- •(5)Combined with coronary heart disease or chronic heart failure. New York Heart Association (NYHA) class III or IV. History of acute coronary syndrome, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
- •(6)Diabetes, hypothyroidism, systolic blood pressure (SBP) = 160mmHg or diastolic blood pressure (DBP) = 100mmHg.
- •(7)Pregnancy or lactation. Females with pregnancy plans or reluctant to take contraceptive measures are also excluded.
- •(8)Suffered from severe trauma or surgery within 3 months, such as gastrointestinal bleeding.
- •(9)Body mass index = 30.
- •(10)Weight fluctuation = 3kg in recent 6 months;
- •(11)History of mental illness, alcohol / drug dependence or malignant tumor.
- •(12)Got COVID-19 vaccine or participated in other clinical trials within 3 months.
- •(13)Not suitable to be enrolled after evaluation by the investigators.
研究者
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