HypercholesterolemiaNCT06301906
Red Yeast Rice for Primary Prevention of Hypercholesterolemia
An observational study of Hypercholesterolemia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men only
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- LipoCol Forte Capsule 600mg twice a day
- Type of treatment
- Pill or oral medicine
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2024to 31 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 to 55 years
- Men only
- No healthy volunteers
- Adult
Study population: The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition.
Who may be able to join
- Aged 35~55 years old
- LDL-C≥130mg/dl or patients with diabetes or chronic kidney disease with LDL-C ≥ 100mg/dl
- expected to receive LipoCol Forte Capsule 600mg bid
Who cannot join
- Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month;
- Female;
- Have experienced rhabdomyolysis or abnormal liver function ALT >72 U/L due to taking red yeast rice;
- Bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month
- Liver insufficiency ALT >72 U/L or renal insufficiency eGFR < 30 mL/min/1.73 m2;
- Have ever had coronary heart disease, myocardial infarction or cerebrovascular disease;
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- Stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated;
- Uncontrolled hypertension (blood pressure ≥160/100 mmHg);
- Use antibiotics, probiotics or weight-loss drugs for more than 3 consecutive days within 3 months before inclusion in the study;
- Drug abuse or poor compliance;
- Use of traditional Chinese medicine in the past month
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taoyuan branch of Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
About this study
Official title: Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Red Yeast Rice for Primary Prevention of Hypercholesterolemia: A Pilot Observational Study
This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota.
- Conditions
- Hypercholesterolemia
- Being tested
- LipoCol Forte Capsule 600mg twice a day
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoCol Forte Capsule 600mg twice a dayDrug
LipoCol Forte Capsule 600mg twice a day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: LipoCol Forte Capsule 600mg twice a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Density Lipoprotein-Cholesterol (LDL-C)
This study will evaluate the efficacy and durability of LipoCol Forte capsules in the primary prevention of hypercholesterolemia.
Measured: before treatment, and 3, 6, 9, 12 months after treatments
Secondary outcomes (1)
10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk
use ASCVD risk estimator to calculate the 10-Year ASCVD Risk after LipoCol Forte capsules treatment
Measured: before treatment, and 3, 6, 9, 12 months after treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start26 Feb 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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 Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301906
- Sponsor's protocol ID
- 202301060A3
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Red Yeast Rice for Primary Prevention of Hypercholesterolemia: A Pilot Observational Study
- ClinicalTrials.gov ID
- NCT06301906
- Acronym / sponsor ID
- 202301060A3
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Mar 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 two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: LipoCol Forte Capsule 600mg twice a day |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition.
Key inclusion criteria (3 listed)
- Aged 35~55 years old
- LDL-C≥130mg/dl or patients with diabetes or chronic kidney disease with LDL-C ≥ 100mg/dl
- expected to receive LipoCol Forte Capsule 600mg bid
Key exclusion criteria (11 listed)
- Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month;
- Female;
- Have experienced rhabdomyolysis or abnormal liver function ALT >72 U/L due to taking red yeast rice;
- Bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month
- Liver insufficiency ALT >72 U/L or renal insufficiency eGFR < 30 mL/min/1.73 m2;
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 |
|---|---|---|
| LipoCol Forte Capsule 600mg twice a dayLipoCol Forte Capsule 600mg twice a day for 12 months | Drug | Group 1 |
Primary outcome
Low Density Lipoprotein-Cholesterol (LDL-C)
Time frame: before treatment, and 3, 6, 9, 12 months after treatments
This study will evaluate the efficacy and durability of LipoCol Forte capsules in the primary prevention of hypercholesterolemia.
1 secondary outcome
10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk
Time frame: before treatment, and 3, 6, 9, 12 months after treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
Related trials for Hypercholesterolemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Density Lipoprotein-Cholesterol (LDL-C) (time frame: before treatment, and 3, 6, 9, 12 months after treatments). 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 20 Mar 2026.