Zhibitai Capsules for the Treatment of Primary Hyperlipidemia
ConditionPrimary Hyperlipidemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChengdu Diao Jiuhong Pharmaceutical Factory
About this trial
Exploring the benefit risk ratio of increase in dosage of Zhibitai capsules (2 capsules at a time, 2 times a day) compared to the original dosage (1 capsule at a time, 1 day)
Eligibility criteria
Qualifiers
Age between 18 and 75 years old (inclusive), regardless of gender;
BMI (Body Mass Index) between 18.0 kg/m² and 30.0 kg/m²;
Meets the diagnostic criteria for primary hyperlipidemia (tan yu hu jie, qi xue bu li zheng);
LDL-C level ≥ 3.4 mmol/L and TG level ≤ 4.5 mmol/L;
Disqualifiers
Known or suspected allergy to any component of the investigational product, or having an allergic constitution.
According to the "Chinese Guidelines for Lipid Management (2023)", individuals classified as being at very high risk or extremely high risk for ASCVD.
Confirmed homozygous familial hypercholesterolemia.
Dyslipidemia caused by secondary reasons, such as nephrotic syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen storage disease, myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome, drug-induced causes (e.g., phenothiazines, beta-blockers, glucocorticoids, certain contraceptives, etc.), or patients currently using heparin, thyroid hormone therapy, or other medications that affect lipid metabolism.
Trial design
Treatments tested in this trial
- zhibitai capsule
- zhibitai capsule
Treatment groups
192 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov