Efficacy, Safety and Mechanism of Modified Xianyaoyin in Patients with Mild to Moderate Hypertriglyceridemia: A Study Protocol for a Multicenter and Randomized Controlled Trial

Phase 1

• Conditions: Hypertriglyceridemia

• Registration Number: ITMCTR2200006417
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(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.

Exclusion Criteria

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fasting triglycerides;

Secondary Outcome Measures

Name	Time	Method
fasting low-density lipoprotein cholesterol;fasting high-density lipoprotein cholesterol;body mass index;fasting total cholesterol;TCM Syndromes Scale;lipoprotein a;degree of fatty liver;