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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General information
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Incorrect insertion of the scientific and common name related to the trial
Incorrect insertion of the scientific and common name related to the trial
empty
اشتباه درج شدن نام علمی و عمومی مربوط به کارآزمایی
اشتباه درج شدن نام علمی و عمومی مربوط به کارآزمایی
Effect of Syrian mesquite (Prosopis farcta) capsules on blood lipids and vascular inflammation
Studying the effect of consuming Prosopis farcta capsules on reducing blood lipids and vascular inflammation
EffectStudying the effect of Syrian mesquite (consuming Prosopis farcta) capsules on reducing blood lipids and vascular inflammation
بررسی اثر مصرف کپسول گیاه عناب سوریه‌ای (Prosopis farcta) بر کاهش چربی خون و التهاب عروقی
بررسی اثر مصرف کپسول گیاه کهورک (Prosopis farcta) بر کاهش چربی خون و التهاب عروقی
بررسی اثر مصرف کپسول گیاه عناب سوریهایکهورک (Prosopis farcta) بر کاهش چربی خون و التهاب عروقی
Effect of Prosopis farcta root extract capsules on lipid profile, inflammatory markers, and vascular function in patients with mild to moderate hyperlipidemia
Studying the effect of Prosopis farcta root extract capsules on lipid profile, inflammatory markers, and vascular function in patients with mild to moderate hyperlipidemia
EffectStudying the effect of Prosopis farcta root extract capsules on lipid profile, inflammatory markers, and vascular function in patients with mild to moderate hyperlipidemia
بررسی اثر کپسول عصاره ریشه گیاه Prosopis farcta (عناب سوریه‌ای) بر پروفایل لیپیدی، نشانگرهای التهابی و عملکرد عروقی در بیماران مبتلا به هیپرلیپیدمی خفیف تا متوسط
بررسی اثر کپسول عصاره ریشه گیاه کهورک (Prosopis farcta) بر پروفایل لیپیدی، نشانگرهای التهابی و عملکرد عروقی در بیماران مبتلا به هیپرلیپیدمی خفیف تا متوسط
بررسی اثر کپسول عصاره ریشه گیاه کهورک (Prosopis farcta (عناب سوریه‌ای) بر پروفایل لیپیدی، نشانگرهای التهابی و عملکرد عروقی در بیماران مبتلا به هیپرلیپیدمی خفیف تا متوسط
Protocol summary
Study aim
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
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
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
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
Reason for update
Incorrect insertion of the scientific and common name related to the trial
Acronym
Prosopis-LIPID1404
IRCT registration information
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
Registration date
2025-11-19, 1404/08/28
Registrant information
Name
MohammadHossein Sahami Gilan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4523 9603
Email address
sahami.mh@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of Prosopis farcta root extract capsules on lipid profile, inflammatory markers, and vascular function in patients with mild to moderate hyperlipidemia
Public title
Studying the effect of consuming Prosopis farcta capsules on reducing blood lipids and vascular inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences, Ilam University of Medical Sciences, Banganjab, Ilam City, 3rd Floor, Secretariat Unit
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2025-06-29, 1404/04/08
Ethics committee reference number
IR.MEDILAM.REC.1404.069
Health conditions studied
1
Description of health condition studied
Mild to moderate hyperlipidemia – Dyslipidemia – Disorders of lipoprotein metabolism – Early cardiovascular disease – Prevention of atherosclerosis
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia, unspecified
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ilam
Full name of responsible person
Alireza Vasiee
Street address
Ayatollah Heydari Street
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 4500
Email
rezawest10@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Naser Abbasi
Street address
Secretariat, 3rd Floor, Vice-Chancellor Building, Ilam University of Medical Sciences, Banganjab, Research Blvd
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3223 5724
Email
abbasi-n@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Alireza Vasiee
Position
Clinical Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7091
Email
rezawest10@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Alireza Vasiee
Position
Clinical Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7091
Email
rezawest10@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
MohammadHossein Sahami Gilan
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Cedar Alley 2, Police Town
City
Eslamabadgharb
Province
Kermanshah
Postal code
6761948443
Phone
+98 83 4523 9603
Email
sahami.mh@medilam.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A decision will be made by the research team at the end of the study.
When the data will become available and for how long
A decision will be made by the research team at the end of the study.
To whom data/document is available
A decision will be made by the research team at the end of the study.
Under which criteria data/document could be used
A decision will be made by the research team at the end of the study.
From where data/document is obtainable
Contact the email address rezawest10@gmail.com.
What processes are involved for a request to access data/document