Clinical trial NCT05095480: Effect of Red Yeast Rice Beside Statin on Lipid Profile
Official title: Does Adding Red Yeast Rice to Statin Can Improve Lipid Profile or Vascular Inflammation? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemias
Keywords: Hyperlipidemia
Statin
Lesstat
Red Yeast Rice
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 92
Sex: ALL
Minimum age (years): 55
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: treatment and placebo received their drugs in their group
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total cholesterol level
timeFrame: 1months
measure: Rise of SGOT ( AST)
timeFrame: 1 months
measure: HS-CRP
timeFrame: 1 months
measure: LDL level
timeFrame: 1 months
measure: Triglyceride level
timeFrame: 1 months
measure: HDL cholesterol
timeFrame: 1 months
measure: SGPT( ALT) level
timeFrame: 1 months
measure: CPK
timeFrame: 1 months
Secondary outcomes:
measure: Muscular pain
timeFrame: 1 months
measure: GI upset
timeFrame: 1 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Javad Kojuri
state: Outside Of The US
Study officials:
affiliation: Professor Kojuri Cardiology clinic
name: javad kojuri, MD
role: PRINCIPAL_INVESTIGATOR
References: