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IRCT20230808059089N4 IRCT 2025-11-19 Ilam University of Medical Sciences Studying the effect of consuming Prosopis farcta capsules on reducing blood lipids and vascular inflammation Prosopis-LIPID1404 Studying the effect of Prosopis farcta root extract capsules on lipid profile, inflammatory markers, and vascular function in patients with mild to moderate hyperlipidemia 2025-12-22 anticipated 80 Complete https://irct.ir/trial/87574 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, eligible individuals will be screened based on inclusion and exclusion criteria. Then, a balanced block randomization method with block sizes of 4 and 6 will be used. Blocks used: PPGG, PGPG, PGGP, GGPP, GPGP, GPPG where P = intervention (Prosopis) and G = placebo (Placebo). The block sequence is generated by RAS (Research Analysis and Statistics) software or SealedEnvelope.com and the selection of each block is done with a random number table. Allocation is done by an independent pharmacist (outside the research team), Blinding description: The intervention and placebo capsules are identical in shape, color, odor, taste, and packaging. Coding is performed by an independent pharmacist. Patients, the principal investigator, the data collection nurse, the laboratory assessor, and the statistical analyst are unaware of the group allocation until the final analysis. Decoding will only be performed after the database is locked and the initial statistical analysis is complete. 3 Mild to moderate hyperlipidemia – Dyslipidemia – Disorders of lipoprotein metabolism – Early cardiovascular disease – Prevention of atherosclerosis. Intervention 1: Intervention group: Prosopis farcta root extract capsule (Syrian mesquite)Dose: 400 mg of standardized dry aqueous extract (standardized to minimum 5% total flavonoids by UV-Vis spectrophotometry)Regimen: One 400 mg capsule daily with dinner for 8 consecutive weeksDosage form: Hard gelatin capsule size 0Manufacturer: GMP-certified pharmaceutical laboratory of University Herbal Medicine Research CenterExcipients: Microcrystalline cellulose, magnesium stearate, colloidal silicon dioxideStandardized low-fat diet and moderate physical activity counseling provided at baseline. Intervention 2: Control group: Placebo capsuleComposition: Lactose monohydrate + microcrystalline cellulose + magnesium stearate + trace amount of approved food coloring (to match intervention capsule exactly)Regimen: One capsule daily with dinner for 8 weeksAppearance: Completely identical to intervention capsule (size, color, smell, taste, packaging)Manufacturer: Same as intervention capsuleDiet and physical activity counseling: Identical to intervention group. Yes - There is a plan to make this available What will be shared: A decision will be made by the research team at the end of the study. When: A decision will be made by the research team at the end of the study. To whom: A decision will be made by the research team at the end of the study. Conditions: A decision will be made by the research team at the end of the study. Where to obtain: Contact the email address rezawest10@gmail.com. How to obtain: Contact the email address rezawest10@gmail.com. Comments:
public Alireza Vasiee
Pazhohesh Boulevard
Ilam Iran (Islamic Republic of) 6939177143 +98 84 3222 7091 rezawest10@gmail.com Ilam University of Medical Sciences scientific Alireza Vasiee
Pazhohesh Boulevard
Ilam Iran (Islamic Republic of) 6939177143 +98 84 3222 7091 rezawest10@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Age 18–65 years Mild to moderate hyperlipidemia (LDL-C ≥ 130 mg/dL and < 190 mg/dL or TG ≥ 150 mg/dL and < 500 mg/dL) according to NCEP ATP III No lipid-lowering drugs in the past 4 weeks Ability to read, write, and sign informed consent BMI 18.5–35 kg/m² 18 years 65 years Both Pregnancy or lactation Uncontrolled diabetes (HbA1c > 8%) Severe liver (ALT/AST > 3× ULN) or kidney disease (eGFR < 30 mL/min) Heart failure NYHA class III–IV Concomitant use of strong CYP3A4 inhibitors/inducers Known allergy to Fabaceae family plants Use of herbal supplements or antioxidants in the past 2 weeks Active malignancy Systemic corticosteroid use in the past month Unwillingness to participate E78.5 Hyperlipidemia, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Prosopis farcta root extract capsule (Syrian mesquite)Dose: 400 mg of standardized dry aqueous extract (standardized to minimum 5% total flavonoids by UV-Vis spectrophotometry)Regimen: One 400 mg capsule daily with dinner for 8 consecutive weeksDosage form: Hard gelatin capsule size 0Manufacturer: GMP-certified pharmaceutical laboratory of University Herbal Medicine Research CenterExcipients: Microcrystalline cellulose, magnesium stearate, colloidal silicon dioxideStandardized low-fat diet and moderate physical activity counseling provided at baseline Control group: Placebo capsuleComposition: Lactose monohydrate + microcrystalline cellulose + magnesium stearate + trace amount of approved food coloring (to match intervention capsule exactly)Regimen: One capsule daily with dinner for 8 weeksAppearance: Completely identical to intervention capsule (size, color, smell, taste, packaging)Manufacturer: Same as intervention capsuleDiet and physical activity counseling: Identical to intervention group Change from baseline in mean serum low-density lipoprotein cholesterol (LDL-C) level at week 8. Timepoint: Day 0 (baseline, before starting the capsules) and Day 56 ± 3 (end of week 8 of intervention). Method of measurement: 5 mL fasting (12–14 hours) venous blood sample, measured by enzymatic colorimetric method using Pars Azmoon commercial kit or equivalent on Hitachi 917 or Beckman Coulter AU5800 autoanalyzer, daily calibration and internal/external quality control. Ilam University of Medical Sciences Approved 2025-06-29 Ethics Committee of Ilam University of Medical Sciences Ilam University of Medical Sciences, Ilam University of Medical Sciences, Banganjab, Ilam City, 3rd Floor, Secretariat Unit Ilam Ilam Iran (Islamic Republic of)