Does Adding Red Yeast Rice to Statin Can Improve Lipid Profile or Vascular Inflammation? A Randomized Clinical Trial

A triple-blind clinical trial on 92 patients in 2019 was conducted. Patients were randomly divided into a control group of 49 patients and a treatment group of 43 patients. The block randomization method with a block size=2 and a ratio of 2:2 for drug vs. placebo was used. Participants were selected from cardiology center (Prof. Kojuri cardiology clinic, Niayesh St., Shiraz, Iran, www.kojuriclinic.com, Instagram @Kojuri_clinic) who took part in this trial voluntarily and were completely informed about the study.

Primarily, some blood tests were done for all of the participants in order to measure their serum levels of LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), total cholesterol, triglyceride (TG), and high sensitivity C-reactive protein (hs-CRP). The patients with very high levels of serum LDL-C (above 200 mg/dL) and those with serum levels of LDL-C below 100m/dL were excluded from the trial.

Food supplements based on red yeast rice were given to the patients of the treatment group in the form of tablets named Lesstat® (Gricar chemical Srl Co.). Each tablet contained 200 mg fermented red rice with Monascus Purpureus tit 5% in Monacolin K, 10 mg equal to Monacolin K, 90 mg chitosan, 3.5 mg lycopene, 30 mg ascorbic acid (vitamin C), and 5 mg tocopherol (vitamin E).

In order to ensure blindness, the placebo tablets were similar to Lesstat (RYR) tablets in shape and color. Both RYR and placebo tablets were given to the patients in identical packages and every package contained 30 tablets of RYR or placebo, which was designed for a one-month use.

After the prescription, the participants were told to take one tablet daily in addition to their routine statin therapy for a period of 30 days. The patients were encouraged to contact us if they had any problems during that 30-day period.