Protocol summary
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Study aim
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To evaluate the effect of 8 weeks daily Prosopis farcta root extract capsule (400 mg) on LDL-C and inflammatory-vascular markers in mild to moderate hyperlipidemia
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Design
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Randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial
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Settings and conduct
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80 patients will be allocated in a 1:1 balanced randomised block design. Complete blinding by an independent pharmacist. Conducted in the internal medicine ward of Imam Khomeini Hospital, Ilam University of Medical Sciences
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Participants/Inclusion and exclusion criteria
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Eighty 18–65-year-old patients with mild-moderate hyperlipidemia (LDL-C 130–190 mg/dL or TG 150–499 mg/dL), not taking lipid-lowering drugs in the past 4 weeks. Inclusion: informed consent, BMI 18.5–35. Exclusion: pregnancy, uncontrolled diabetes, severe liver/kidney disease, advanced heart failure, Fabaceae allergy, recent statin or herbal supplement use
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Intervention groups
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Intervention: 400 mg standardized aqueous root extract of Prosopis farcta, one capsule daily with dinner for 8 weeks
Control: identical placebo capsule, one daily for 8 weeks
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Main outcome variables
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Primary: change in LDL-C from baseline to week 8
Secondary: changes in TC, TG, HDL-C, hs-CRP, blood pressure, brachial FMD, quality of life (MYMOP2, SF-36), and safety
General information
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Reason for update
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Incorrect insertion of the scientific and common name related to the trial
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Acronym
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Prosopis-LIPID1404
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IRCT registration information
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IRCT registration number:
IRCT20230808059089N4
Registration date:
2025-11-19, 1404/08/28
Registration timing:
prospective
Last update:
2025-11-25, 1404/09/04
Update count:
1
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Registration date
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2025-11-19, 1404/08/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-12-22, 1404/10/01
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Expected recruitment end date
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2026-03-20, 1404/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Studying the effect of Prosopis farcta root extract capsules on lipid profile, inflammatory markers, and vascular function in patients with mild to moderate hyperlipidemia
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Public title
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Studying the effect of consuming Prosopis farcta capsules on reducing blood lipids and vascular inflammation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-06-29, 1404/04/08
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Ethics committee reference number
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IR.MEDILAM.REC.1404.069
Health conditions studied
1
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Description of health condition studied
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Mild to moderate hyperlipidemia – Dyslipidemia – Disorders of lipoprotein metabolism – Early cardiovascular disease – Prevention of atherosclerosis
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ICD-10 code
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E78.5
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ICD-10 code description
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Hyperlipidemia, unspecified
Primary outcomes
1
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Description
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Change from baseline in mean serum low-density lipoprotein cholesterol (LDL-C) level at week 8
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Timepoint
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Day 0 (baseline, before starting the capsules) and Day 56 ± 3 (end of week 8 of intervention)
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Method of measurement
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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
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ilam University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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A decision will be made by the research team at the end of the study.
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When the data will become available and for how long
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A decision will be made by the research team at the end of the study.
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To whom data/document is available
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A decision will be made by the research team at the end of the study.
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Under which criteria data/document could be used
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A decision will be made by the research team at the end of the study.
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From where data/document is obtainable
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Contact the email address rezawest10@gmail.com.
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What processes are involved for a request to access data/document
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Contact the email address rezawest10@gmail.com.
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Comments
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