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Efficacy and safety of Qushi Huayu granule for hyperlipidemia: study protocol for a randomized, double-blind,
Yuanlong Sun1, Na Hu1, Gaofeng Chen1
1Key Laboratory of Liver and Kidney Diseases (Ministry of Education), Institute of Liver Diseases, Shanghai Key Laboratory of Traditional Chinese Clinical Medicine, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, No. 528 Zhangheng Road, Pudong New Area, Shanghai, 201203, China.
Insights
This study evaluates Qushi Huayu granules (QSHY) for hyperlipidemia management. Results will show QSHY
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Traditional Chinese Medicine
Background:
- Hyperlipidemia is a prevalent global chronic disease, increasing atherosclerosis and coronary heart disease risk.
- High serum low-density lipoprotein cholesterol (LDL-C) is a key indicator in hyperlipidemia patients.
- Qushi Huayu granules (QSHY) show potential in reducing blood lipids, particularly in non-alcoholic fatty liver disease (NAFLD) patients with hyperlipidemia.
Purpose of the Study:
- To investigate the clinical efficacy and safety of Qushi Huayu granules (QSHY) for treating hyperlipidemia.
- To assess the impact of QSHY on serum lipid levels, quality of life, and Traditional Chinese Medicine (TCM) patterns in hyperlipidemia patients.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 210 participants.
- Participants will be randomized to receive either QSHY or placebo granules for 24 weeks.
- Primary outcome: change in LDL-C at 12 weeks; secondary outcomes: changes in other lipids, quality of life, and TCM patterns; safety monitoring.
Main Results:
- Data collection and analysis are ongoing as per the trial protocol.
- The study is designed to provide robust evidence on QSHY's effectiveness and safety.
Conclusions:
- This clinical trial will determine the efficacy and safety of QSHY, a TCM prescription, in managing hyperlipidemia.
- Findings will contribute to understanding QSHY's role in cardiovascular health and lipid management.
Background:
Hyperlipidemia has become a common chronic disease worldwide in recent years. Studies have shown that hyperlipidemia patients, especially those with a high level of serum low-density lipoprotein cholesterol (LDL-C), have a significantly higher prevalence of atherosclerosis, leading to coronary heart disease. Previous basic experiments and clinical studies have shown that Qushi Huayu granules (QSHY) reduce blood lipids in patients with non-alcoholic fatty liver disease (NAFLD) accompanied by hyperlipidemia. However, the clinical efficacy of QSHY in patients with hyperlipidemia is still lacking. This study aims to investigate the effect and safety of QSHY for hyperlipidemia.
Methods:
This is a randomized, double-blind, placebo-controlled trial. A total of 210 participants will be enrolled and randomized into the QSHY or placebo granules groups in equal proportions, who will receive treatment for 24 weeks. The primary outcome will be the change in LDL-C from baseline to week 12. Secondary outcomes will be changes in other serum lipids markers, life quality measuring health surveys, and traditional Chinese medicine (TCM) pattern scale. All related tests will be measured at baseline, week 12, and week 24 after enrollment. Adverse events and the safety of intervention will be monitored and evaluated.
Discussion:
We designed a clinical trial of hyperlipidemia management with QSHY, a TCM prescription. The results of this trial will present the efficacy and safety of QSHY in patients with hyperlipidemia.
Trial Registration:
Chinese Clinical Trial Registry ChiCTR2000034125 . Registered on June 25, 2019.
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