Effect of Red Yeast Rice Beside Statin on Lipid Profile
NCT ID: NCT05095480
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
92 participants
INTERVENTIONAL
2019-03-01
2021-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lesstat
Those who received Lesstat
Red Yeast Rice Pill
Taking Lesstat
Placebo
Those who received Lesstat
Placebo
Placebo receiving group
Interventions
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Red Yeast Rice Pill
Taking Lesstat
Placebo
Placebo receiving group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hypersensitivity to orlistat
* Using other lipid-lowering agents with statins
* History of liver disease
* Pregnancy.
55 Years
72 Years
ALL
Yes
Sponsors
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Shiraz University of Medical Sciences
OTHER
Responsible Party
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Javad Kojuri
Professor
Principal Investigators
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javad kojuri, MD
Role: PRINCIPAL_INVESTIGATOR
Professor Kojuri Cardiology clinic
Locations
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Javad Kojuri
Shiraz, Outside of the US, Iran
Countries
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References
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Tavan A, Noroozi S, Zamiri B, Gholchin Vafa R, Rahmani M, Mehdizadeh Parizi M, Ahmadi A, Heydarzade R, Montaseri M, Hosseini SA, Kojuri J. Evaluation the effects of red yeast rice in combination with statin on lipid profile and inflammatory indices; a randomized clinical trial. BMC Nutr. 2022 Nov 25;8(1):138. doi: 10.1186/s40795-022-00639-z.
Other Identifiers
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IR.SUMS.MED.REC.1399.840
Identifier Type: -
Identifier Source: org_study_id