Effect of Red Yeast Rice Beside Statin on Lipid Profile

Hyperlipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095480
• Other study ID #: IR.SUMS.MED.REC.1399.840
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: October 2021
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Javad Kojuri	Shiraz	Outside Of The US

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol level	The level of total cholesterol, mg/dl	1months
Primary	Rise of SGOT ( AST)	Rise of serum SGOT,(AST) as liver enzyme, unit per liter	1 months
Primary	HS-CRP	Inflammation of intravascular, and surrogate marker of atherosclerosis activity, pico/dl	1 months
Primary	LDL level	The serum level of LDL cholesterol, mg/dl	1 months
Primary	Triglyceride level	The serum level of triglyceride, mg/dl	1 months
Primary	HDL cholesterol	The serum level of HDL cholesterol, mg/dl	1 months
Primary	SGPT( ALT) level	The serum level of SGPT( ALT) U/L	1 months
Primary	CPK	Serum CPK level , IU/L	1 months
Secondary	Muscular pain	Severe muscular pain, based on patient report	1 months
Secondary	GI upset	Any sever gastrointestinal symptoms, reported by patient	1 months