Effect of Red Yeast Rice Beside Statin on Lipid Profile

Overview

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

Full Title of Study: “Does Adding Red Yeast Rice to Statin Can Improve Lipid Profile or Vascular Inflammation? A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 1, 2021

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.

Interventions

  • Drug: Red Yeast Rice Pill
    • Taking Lesstat
  • Drug: Placebo
    • Placebo receiving group

Arms, Groups and Cohorts

  • Experimental: Lesstat
    • Those who received Lesstat
  • Placebo Comparator: Placebo
    • Those who received Lesstat

Clinical Trial Outcome Measures

Primary Measures

  • Total cholesterol level
    • Time Frame: 1months
    • The level of total cholesterol, mg/dl
  • Rise of SGOT ( AST)
    • Time Frame: 1 months
    • Rise of serum SGOT,(AST) as liver enzyme, unit per liter
  • HS-CRP
    • Time Frame: 1 months
    • Inflammation of intravascular, and surrogate marker of atherosclerosis activity, pico/dl
  • LDL level
    • Time Frame: 1 months
    • The serum level of LDL cholesterol, mg/dl
  • Triglyceride level
    • Time Frame: 1 months
    • The serum level of triglyceride, mg/dl
  • HDL cholesterol
    • Time Frame: 1 months
    • The serum level of HDL cholesterol, mg/dl
  • SGPT( ALT) level
    • Time Frame: 1 months
    • The serum level of SGPT( ALT) U/L
  • CPK
    • Time Frame: 1 months
    • Serum CPK level , IU/L

Secondary Measures

  • Muscular pain
    • Time Frame: 1 months
    • Severe muscular pain, based on patient report
  • GI upset
    • Time Frame: 1 months
    • Any sever gastrointestinal symptoms, reported by patient

Participating in This Clinical Trial

Inclusion Criteria

  • Having serum levels of LDL cholesterol (LDL-C) at least 100 mg/dL and being treated with any group of statins for at least 3 months prior to the trial. Exclusion Criteria:

  • Having very high serum levels of LDL-C (above 200 mg/dL) – Hypersensitivity to orlistat – Using other lipid-lowering agents with statins – History of liver disease – Pregnancy.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 72 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shiraz University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Javad Kojuri, Professor – Shiraz University of Medical Sciences
  • Overall Official(s)
    • javad kojuri, MD, Principal Investigator, Professor Kojuri Cardiology clinic

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