HyperlipidemiasPhase 4NCT05095480
Effect of Red Yeast Rice Beside Statin on Lipid Profile
A Phase 4 study testing Red Yeast Rice Pill in people with Hyperlipidemias, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 Read more about this study
- Who is it for?
- Ages 55 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Red Yeast Rice Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2019to 1 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Hyperlipidemias
- Being tested
- Red Yeast Rice Pill, Placebo
- Keywords
- Hyperlipidemia, Statin, Lesstat, Red Yeast Rice
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Yeast Rice PillDrug
Also called Lesstat
Taking Lesstat
PlaceboDrug
Placebo receiving group
| Study group | Role | What they receive |
|---|---|---|
| Lesstat | Experimental | Those who received Lesstat Receives: Drug: Red Yeast Rice Pill |
| Placebo | Placebo comparator | Those who received Lesstat Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol level
The level of total cholesterol, mg/dl
Measured: 1months
Rise of SGOT ( AST)
Rise of serum SGOT,(AST) as liver enzyme, unit per liter
Measured: 1 months
HS-CRP
Inflammation of intravascular, and surrogate marker of atherosclerosis activity, pico/dl
Measured: 1 months
LDL level
The serum level of LDL cholesterol, mg/dl
Measured: 1 months
Triglyceride level
The serum level of triglyceride, mg/dl
Measured: 1 months
HDL cholesterol
The serum level of HDL cholesterol, mg/dl
Measured: 1 months
SGPT( ALT) level
The serum level of SGPT( ALT) U/L
Measured: 1 months
CPK
Serum CPK level , IU/L
Measured: 1 months
Secondary outcomes (2)
Muscular pain
Severe muscular pain, based on patient report
Measured: 1 months
GI upset
Any sever gastrointestinal symptoms, reported by patient
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Mar 2019
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- treatment and placebo received their drugs in their group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
- Investigators
- javad kojuri, MD, Principal investigator, Professor Kojuri Cardiology clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095480
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1399.840
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only the result of study is available
Publications
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.
PubMed 36434733
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding Red Yeast Rice to Statin Can Improve Lipid Profile or Vascular Inflammation? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05095480
- Acronym / sponsor ID
- IR.SUMS.MED.REC.1399.840
- Conditions
- Hyperlipidemias
- Keywords
- Hyperlipidemia, Statin, Lesstat, Red Yeast Rice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- treatment and placebo received their drugs in their group
| Arm | Type | Receives |
|---|---|---|
| Lesstat | Experimental | Drug: Red Yeast Rice PillThose who received Lesstat |
| Placebo | Placebo comparator | Drug: PlaceboThose who received Lesstat |
Who may qualify
- Ages
- 55 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Yeast Rice PillAlso: LesstatTaking Lesstat | Drug | Lesstat |
| PlaceboPlacebo receiving group | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Muscular pain
Time frame: 1 months
GI upset
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 36434733Tavan 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.
- Individual participant dataSharing planned: No. only the result of study is available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
javad kojuri, MD principal investigator
Professor Kojuri Cardiology clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Red Yeast Rice Pill in people with Hyperlipidemias, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol level (time frame: 1months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.