A prospective randomized controlled clinical trial for QSHY granule in the treatment of hyperlipidemia of phlegm and blood stasis type

Phase 1

• Conditions: Hyperlipidemia

• Registration Number: ITMCTR2000003430
• Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

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. For patients who meet the diagnostic criteria of Chinese and Western medicine for hyperlipidemia, the guidelines for the prevention and treatment of Chinese adult dyslipidemia in 2016 were revised by referring to the guidelines for the prevention and treatment of Chinese adult dyslipidemia. TCM diagnosis, syndrome differentiation criteria and their basis refer to the TCM diagnosis and treatment criteria for dyslipidemia of the heart disease branch of the Chinese society of TCM.
2. Patients older than 18 years old;
3. In the absence of ASCVD, 3.4mmol/l (130mg / dl) was less than 4.9mmol/l (190mg / dl); in the absence of ASCVD, 2.6mmol/l (100mg / dl) was less than 4.9mmol/l (190mg / dl);
4. Patients with fasting TG < 5.7 mmol/L (500mg/dL);
5. BMI < 35 kg/m2;
6. Willing and able to follow the scheduled visit plan, diet and exercise instructions, laboratory tests and other procedures.
7. Patients who signed informed consent.

Exclusion Criteria

1. The patients who used other lipid-lowering drugs in the first 4 weeks were screened;
2. Patients with uncontrolled endocrine or metabolic diseases that may interfere with blood lipid levels;
3. Patients taking oral corticosteroids;
4. Screening of patients with a history of alcohol or narcotic drug abuse in the previous year;
5. Patients with high or very high risk of ASCVD;
6. Patients with congestive heart failure, unstable angina, myocardial infarction, stroke, coronary artery bypass surgery or angioplasty, or unstable or serious peripheral artery disease in the first 6 months were screened;
7. Patients who have undergone gastrointestinal surgery in the past year or who have taken weight-loss drugs in the past 3 months have lost more than 10% of their body weight;
8. Pregnant women, lactating women and patients with cardiovascular, lung, kidney, hematopoietic system and other major diseases such as malignant tumors.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
serum lipid;

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose;routine blood test;Hepatorenal function;routine urine test;