Effect of Red Yeast Rice Beside Statin on Lipid Profile

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

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

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Drug: Red Yeast Rice Pill; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Outside Of The US
    • Shiraz, Outside Of The US, Iran, Islamic Republic of, 55318
      • Javad Kojuri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 72 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lesstat; Those who received Lesstat	Drug: Red Yeast Rice Pill; Taking Lesstat; Other Names: Lesstat
PLACEBO_COMPARATOR: Placebo; Those who received Lesstat	Drug: Placebo; Placebo receiving group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Principal Investigator: javad kojuri, MD, professor Kojuri cardiology clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): March 1, 2021
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (ACTUAL): October 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Hyperlipidemia; Statin; Red Yeast Rice; Lesstat
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Red yeast rice
• Other Study ID Numbers: IR.SUMS.MED.REC.1399.840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only the result of study is available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No