HypercholesterolemiaPhase 2NCT06700408
RCT for the Chinese Medicine in Treating Hypercholesterolemia
A Phase 2 study testing Dachaihu Decoction combined Erzhiwan with variation in people with Hypercholesterolemia, run by Chinese University of Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Dachaihu Decoction combined Erzhiwan with variation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Apr 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old, any gender;
- LDL-C level of 4.1 mmol/L or above (no statin therapy during the screening period);
- Be able to maintain a more consistent lifestyle and eating habits throughout the study;
- Have a fixed residence and are not expected to move or travel for 8 weeks;
- Voluntarily sign the informed consent form.
Who cannot join
- Taking drugs that may affect lipid metabolism (such as steroids, sleeping pills, and psychotropic drugs);
- Alcohol or drug abuse within the last 3 months;
- Known liver function or renal dysfunction;
- History of severe cardiovascular and cerebrovascular diseases; or history of psychiatric illness;
- Participate in other interventional clinical trials within 3 months before the study, including drugs, supplements, medical devices, etc.;
- Known pregnant or lactating women, allergies or allergies to traditional Chinese medicine;
- Patients with known secondary hypercholesterolemia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Dachaihu Decoction Combined Erzhiwan With Variation for the Treatment of Hypercholesterolemia: A Parallel, Randomized, Double-blinded, Placebo-controlled Trial
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.
Read the detailed description
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.
- Conditions
- Hypercholesterolemia
- Being tested
- Dachaihu Decoction combined Erzhiwan with variation, Placebo granules
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dachaihu Decoction combined Erzhiwan with variationDrug
Also called Chinese medicine granules
Chinese medicine granules
Placebo granulesOther
Placebo granules
| Study group | Role | What they receive |
|---|---|---|
| Dachaihu Decoction combined Erzhiwan with variation granules | Experimental | Chinese medicine granules Receives: Drug: Dachaihu Decoction combined Erzhiwan with variation |
| Placebo granules | Placebo comparator | Placebo granules Receives: Other: Placebo granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Compare the percent change in LDL-C levels from baseline to week 8
Measured: 8 weeks
Secondary outcomes (25)
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Compare the percent change in LDL-C levels from baseline to week 4
Measured: 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
Measured: 12 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
The level of LDL-C at week 4
Measured: 4 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
The level of LDL-C at week 8
Measured: 8 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
The level of LDL-C at week 12
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
The level of HDL-C at week 4
Measured: 4 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
The level of HDL-C at week 8
Measured: 8 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
The level of HDL-C at week 12
Measured: 12 weeks
The percent change in Total cholesterol (TC) level
Compare the percent change in TC levels from baseline to week 4
Measured: 4 weeks
The percent change in Total cholesterol (TC) level
Compare the percent change in TC levels from baseline to week 8
Measured: 8 weeks
The percent change in Total cholesterol (TC) level
Compare the percent change in TC levels from baseline to week 12
Measured: 12 weeks
The level of Total cholesterol (TC)
The level of HDL-C at week 4
Measured: 4 weeks
The level of Total cholesterol (TC)
The level of HDL-C at week 8
Measured: 8 weeks
The level of Total cholesterol (TC)
The level of HDL-C at week 12
Measured: 12 weeks
The percent change in Triglycerides (TG)
Compare the percent change in TC levels from baseline to week 4
Measured: 4 weeks
The percent change in Triglycerides (TG)
Compare the percent change in TC levels from baseline to week 8
Measured: 8 weeks
The percent change in Triglycerides (TG)
Compare the percent change in TC levels from baseline to week 12
Measured: 12 weeks
The level of Triglycerides (TG)
The level of Triglycerides (TG) at week 4
Measured: 4 weeks
The level of Triglycerides (TG)
The level of Triglycerides (TG) at week 8
Measured: 8 weeks
The level of Triglycerides (TG)
The level of Triglycerides (TG) at week 12
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study startJan 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, Prof, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700408
- Sponsor's protocol ID
- Hypercholesterolemia study
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dachaihu Decoction Combined Erzhiwan With Variation for the Treatment of Hypercholesterolemia: A Parallel, Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06700408
- Acronym / sponsor ID
- Hypercholesterolemia study
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dachaihu Decoction combined Erzhiwan with variation granules | Experimental | Drug: Dachaihu Decoction combined Erzhiwan with variationChinese medicine granules |
| Placebo granules | Placebo comparator | Other: Placebo granulesPlacebo granules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years old, any gender;
- LDL-C level of 4.1 mmol/L or above (no statin therapy during the screening period);
- Be able to maintain a more consistent lifestyle and eating habits throughout the study;
- Have a fixed residence and are not expected to move or travel for 8 weeks;
- Voluntarily sign the informed consent form.
Key exclusion criteria (7 listed)
- Taking drugs that may affect lipid metabolism (such as steroids, sleeping pills, and psychotropic drugs);
- Alcohol or drug abuse within the last 3 months;
- Known liver function or renal dysfunction;
- History of severe cardiovascular and cerebrovascular diseases; or history of psychiatric illness;
- Participate in other interventional clinical trials within 3 months before the study, including drugs, supplements, medical devices, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dachaihu Decoction combined Erzhiwan with variationAlso: Chinese medicine granulesChinese medicine granules | Drug | Dachaihu Decoction combined Erzhiwan with variation granules |
| Placebo granulesPlacebo granules | Other | Placebo granules |
Primary outcome
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Time frame: 8 weeks
Compare the percent change in LDL-C levels from baseline to week 8
25 secondary outcomes
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Time frame: 4 weeks
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels
Time frame: 12 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
Time frame: 4 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
Time frame: 8 weeks
The level of Low-density lipoprotein-cholesterol (LDL-C)
Time frame: 12 weeks
The percent change in High-density lipoprotein-cholesterol (HDL-C) level
Time frame: 4 weeks
The percent change in High-density lipoprotein-cholesterol (HDL-C) level
Time frame: 8 weeks
The percent change in High-density lipoprotein-cholesterol (HDL-C) level
Time frame: 12 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
Time frame: 4 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
Time frame: 8 weeks
The level of High-density lipoprotein-cholesterol (HDL-C)
Time frame: 12 weeks
The percent change in Total cholesterol (TC) level
Time frame: 4 weeks
The percent change in Total cholesterol (TC) level
Time frame: 8 weeks
The percent change in Total cholesterol (TC) level
Time frame: 12 weeks
The level of Total cholesterol (TC)
Time frame: 4 weeks
The level of Total cholesterol (TC)
Time frame: 8 weeks
The level of Total cholesterol (TC)
Time frame: 12 weeks
The percent change in Triglycerides (TG)
Time frame: 4 weeks
The percent change in Triglycerides (TG)
Time frame: 8 weeks
The percent change in Triglycerides (TG)
Time frame: 12 weeks
The level of Triglycerides (TG)
Time frame: 4 weeks
The level of Triglycerides (TG)
Time frame: 8 weeks
The level of Triglycerides (TG)
Time frame: 12 weeks
Proportion of patients' LDL-c below 70 mg/L
Time frame: 8 weeks
Proportion of patients' LDL-c below 70 mg/L
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhixiu Lin, Prof principal investigator
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dachaihu Decoction combined Erzhiwan with variation in people with Hypercholesterolemia, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhixiu Lin, Prof (39436347, linzx@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent change in Low-density lipoprotein-cholesterol (LDL-C) levels (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.