NCT06301906Completed
Red Yeast Rice for Primary Prevention of Hypercholesterolemia
Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Red Yeast Rice for Primary Prevention of Hypercholesterolemia: A Pilot Observational Study
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 41 (actual)
- First submitted
- 29 Feb 2024
- Start date
- 26 Feb 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06301906
What you commit to
- Study type: Observational
- Participants enrolled: 41
- From 26 Feb 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month;
- 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;
Other illness
- Have ever had coronary heart disease, myocardial infarction or cerebrovascular disease;
- Stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated;
- Uncontrolled hypertension (blood pressure ≥160/100 mmHg);
Lab values
- 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;
Other
- Female;
- Use of traditional Chinese medicine in the past month
Who the study is looking for
- 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
Age in the registry: 35 years to 55 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taoyuan branch of Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.