Effect of Red Yeast Rice Beside Statin on Lipid Profile

NCT05095480 | Completed Phase 4 DMC

• 1 other identifier: IR.SUMS.MED.REC.1399.840
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperlipidemias

Keywords

Hyperlipidemia; Statin; Lesstat; Red Yeast Rice

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Muscular pain

  1 months

• GI upset

  1 months

Study Arms (2)

Lesstat

EXPERIMENTAL

Those who received Lesstat

Drug: Red Yeast Rice Pill

Placebo

PLACEBO COMPARATOR

Those who received Lesstat

Drug: Placebo

Interventions

Red Yeast Rice Pill DRUG

Taking Lesstat

Also known as: Lesstat

Lesstat

Placebo DRUG

Placebo receiving group

Placebo

Eligibility Criteria

• Age: 55 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Javad Kojuri

Shiraz, Outside of the US, 55318, Iran

Location

Related Publications (1)

• 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.

  PMID: 36434733 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Interventions

red yeast rice

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• javad kojuri, MD

  Professor Kojuri Cardiology clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: treatment and placebo received their drugs in their group

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 27, 2021
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)