A Phase 2 interventional study of Dachaihu Decoction combined Erzhiwan with variation and Placebo granules in Hypercholesterolemia, sponsored by Chinese University of Hong Kong. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Chinese University of Hong Kong · Phase 2, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled clinical trial. Eligible subjects will randomized into a treatment group or placebo group. They will receive either Chinese medicine granules or placebo granules for 8 weeks followed by a 4-week observation period. The primary outcome would be the percent change in Low-density lipoprotein cholesterol levels (LDL-C) after treatment.
Hypercholesterolemia refers to a metabolic disease caused by abnormal cholesterol metabolism in the blood cholesterol content exceeding the normal range, which can be mainly divided into total cholesterol (TC) in plasma and low-density lipoprotein cholesterol LDL-C) or a decrease in high-density lipoprotein cholesterol (HDL-C). Uncontrolled hypercholesterolemia is considered an important risk factor for cardiovascular and cerebrovascular diseases.
In recent years, there has been an increasing number of clinical studies of Traditional Chinese Medicine combinations or single herbs for hypercholesterolemia, and some drugs do have cholesterol-lowering effects, but the clinical evidence is not high due to bias or other deficiencies in trial design. Therefore, this clinical trial aim to evaluate the effectiveness of Dachaihu Decoction combined Erzhiwan with variation to the treatment of patients with clinical hypercholesterolemia, and tried to reduce its adverse effects on liver function through reasonable compatibility.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 70 is below the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chinese medicine granules
Drug: Dachaihu Decoction combined Erzhiwan with variation
Placebo granules
Other: Placebo granules
Chinese medicine granules
Also known as: Chinese medicine granules
Placebo granules
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Compare the percent change in LDL-C levels from baseline to week 8
Time frame: 8 weeks
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Compare the percent change in LDL-C levels from baseline to week 4
Time frame: 4 weeks
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Compare the percent change in LDL-C levels from baseline to week 12
Time frame: 12 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
The level of LDL-C at week 4
Time frame: 4 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
The level of LDL-C at week 8
Time frame: 8 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
The level of LDL-C at week 12
Time frame: 12 weeks
The percent change in High-density lipoprotein-cholesterol (HDL-C) level
Compare the percent change in HDL-C levels from baseline to week 4
Time frame: 4 weeks
The percent change in High-density lipoprotein-cholesterol (HDL-C) level
Compare the percent change in HDL-C levels from baseline to week 8
Time frame: 8 weeks
The percent change in High-density lipoprotein-cholesterol (HDL-C) level
Compare the percent change in HDL-C levels from baseline to week 12
Time frame: 12 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
The level of HDL-C at week 4
Time frame: 4 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
The level of HDL-C at week 8
Time frame: 8 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
The level of HDL-C at week 12
Time frame: 12 weeks
The percent change in Total cholesterol (TC) level
Compare the percent change in TC levels from baseline to week 4
Time frame: 4 weeks
The percent change in Total cholesterol (TC) level
Compare the percent change in TC levels from baseline to week 8
Time frame: 8 weeks
The percent change in Total cholesterol (TC) level
Compare the percent change in TC levels from baseline to week 12
Time frame: 12 weeks
The level of Total cholesterol (TC)
The level of HDL-C at week 4
Time frame: 4 weeks
The level of Total cholesterol (TC)
The level of HDL-C at week 8
Time frame: 8 weeks
The level of Total cholesterol (TC)
The level of HDL-C at week 12
Time frame: 12 weeks
The percent change in Triglycerides (TG)
Compare the percent change in TC levels from baseline to week 4
Time frame: 4 weeks
The percent change in Triglycerides (TG)
Compare the percent change in TC levels from baseline to week 8
Time frame: 8 weeks
The percent change in Triglycerides (TG)
Compare the percent change in TC levels from baseline to week 12
Time frame: 12 weeks
The level of Triglycerides (TG)
The level of Triglycerides (TG) at week 4
Time frame: 4 weeks
The level of Triglycerides (TG)
The level of Triglycerides (TG) at week 8
Time frame: 8 weeks
The level of Triglycerides (TG)
The level of Triglycerides (TG) at week 12
Time frame: 12 weeks
Proportion of patients' LDL-c below 70 mg/L
The proportion of patients in the two groups who achieved LDL-C levels below 70 mg/L at week 8
Time frame: 8 weeks
Proportion of patients' LDL-c below 70 mg/L
The proportion of patients in the two groups who achieved LDL-C levels below 70 mg/L at week 12
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →