2.1. Study Design and Participants
muscle toxicity, psychiatric, allergic reaction, dyslipidemia
DISORDERS, DISEASES OF THE HEART, ALLERGIC REACTION, DYSLIPIDEMIA
This double-blind, placebo-controlled, randomized trial was conducted in Jing Yuan County Hospital of Traditional Chinese Medicine, Jingyuan County, Baiyin City, Gansu Province, China, from April 2021 to December 2021 to recruit eligible participants and administer the intervention. Treatment allocation remains masked for patients who subsequently enrolled in the ongoing phase 3 extension study according to age and gender. Inclusion criteria are (1) being aged 30–70 years old; voluntary participation; and (2) having dyslipidemia condition, with TC ≥ 5.2 mmol/L and TG ≥ 1.7 mmol/L. Eligibility required at least two measurements within a 3-month period, with one meeting the criteria. Exclusion criteria included (1) refusal to sign the informed consent; (2) undergoing pregnancy or lactation; (3) allergic reaction to the sample; (4) serious diseases of the heart, liver, renal, hematopoietic system, or psychiatric disorders; and (5) use of medications that are known to regulate lipid within 3 months or others that may affect the effectiveness of the trial.According to previous research,52 cases per group were needed [The trial received approval from the Ethics Committee of the School of Public Health of Southern Medical University and is registered with the Chinese Clinical Trials Registry (No. ChiCRCT20190111). In accordance with the requirements of the Human Subject Protection Review Committee, all subjects were informed about the potential rare side effects of liver and muscle toxicity associated with cholesterol-lowering drugs. The study followed the CONSORT guidelines for reporting randomized controlled trials. The completed checklist and flow diagram can be found in 