Effect of Red Yeast Rice Beside Statin on Lipid Profile
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      We conducted a triple-blind clinical trial on 92 patients in 2019. They were randomly divided
      into a control group of 49 patients and a treatment group of 43 patients. Treatment group
      received Lesstat and placebo group received the same color tablets
    

Detailed description: 
      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.

      All participants were told to come back to our center after one month in order to perform
      some secondary blood tests to compare patients' serum levels of LDL-C, HDL-C, total
      cholesterol, TG, and hs-CRP with the initial measures. We carried out both primary and
      secondary blood tests in the same laboratory and with the use of the same kits. Additionally,
      the levels of serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic
      transaminase (SGPT), and serum total bilirubin of all patients were assessed in order to
      assess possible adverse hepatic effects of this combination (statins and RYR) therapy.

      IBM SPSS software (version 25) for statistical analyses was sed. For comparing the variables
      between the treatment and placebo groups at baseline, the independent sample t-test and
      Pearson chi-squared test were . The paired-sample t-test and repeated measure ANOVA were used
      for the variables with repeated measures. Values of p less than 0.05 were considered to be
      statistically significant.

      All of the participants were totally informed about the purposes and details of our study,
      with giving their informed consent before taking part. Patients refusing to participate were
      excluded from the trial.
    

Intervention name(s): Red Yeast Rice Pill; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Taking Lesstat; Placebo receiving group
Other intervention name(s): Lesstat
Intervention MeSH terms: Red yeast rice
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: treatment and placebo received their drugs in their group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperlipidemia; Statin; Lesstat; Red Yeast Rice