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Antihyperlipidemic herbal softgel

Comparing the effect of herbal soft gel containing dry extract of willow bark, Shirazi chamomile, red pepper, ginger root, cranberry, garlic powder, and hawthorn with placebo on cardiovascular disease risk factors in patients with hyperlipidemia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250407065246N1
Enrollment
70
Registered
2025-05-11
Start date
2025-05-22
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia. Hyperlipidemia, unspecified

Interventions

Intervention 1: Intervention group: Herbal softgel containing hydroalcoholic extract of garlic (Allium sativum) 47.4 mg, cranberry (Vaccinium myrtillus) 20.4 mg, ginger (Zingiber officinale) 14.8 mg,

Sponsors

Gol darou Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age 18 to 60 years Participants with total cholesterol of 200 mg/dL and over Participants with triglyceride 150 mg/dL and over Participants with low density lipoprotein cholesterol from 130 to less than 190 mg/dL Body mass index below 30 kg/m2

Exclusion criteria

Exclusion criteria: Use of alcohol and/or other substances of abuse Diseases affecting serum lipids (e.g., diabetes, thyroid disorders, and pancreatitis). Use of medications or supplements affecting serum lipids (e.g., statins, fibrates, estrogens, progestins, beta-blockers, thiazide diuretics, and fish oil) in the past 2 months Liver or kidney disease Pregnancy Lactation

Design outcomes

Primary

MeasureTime frame
Total cholesterol (TC). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: All venous blood samples were taken in the morning between 7:00 AM and 9:00 AM after a 12-hour fast, and the blood samples were stored at -70°C until biochemical analysis. This test was performed in the laboratory of the Cardiovascular Research Institute using the enzymatic method and a Hitachi autoanalyzer (manufactured by Eppendorf, Germany) and kits from Pars Ozmon.;Triglyceride (TG). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: All venous blood samples were taken in the morning between 7:00 AM and 9:00 AM after a 12-hour fast, and the blood samples were stored at -70°C until biochemical analysis. This test was performed in the laboratory of the Cardiovascular Research Institute using the enzymatic method and a Hitachi autoanalyzer (manufactured by Eppendorf, Germany) and kits from Pars Ozmon.;Low density lipoprotein cholesterol (LDL-C). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: All venous blood samples were taken in the morning between 7:00 AM and 9:00 AM after a 12-hour fast, and the blood samples were stored at -70°C until biochemical analysis. This test was performed in the laboratory of the Cardiovascular Research Institute using the enzymatic method and a Hitachi autoanalyzer (manufactured by Eppendorf, Germany) and kits from Pars Ozmon.;High density lipoprotein cholesterol (HDL-C). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: All venous blood samples were taken in the morning between 7:00 AM and 9:00 AM after a 12-hour fast, and the blood samples were stored at -70°C until biochemical analysis. This test was performed in the laboratory of the Cardiovascular Research Institute using the enzymatic method and a Hitachi autoanalyzer (manufactured by Eppendorf, Germany) and kits from Pars Ozmon

Secondary

MeasureTime frame
Apoprotein A (Apo A). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Apo A was measured using a modified immunotubercular method and according to the instructions of the commercial kit DiaSys, Germany.;Apoprotein B (Apo B). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Apo A was measured using a modified immunotubercular method and according to the instructions of the commercial kit DiaSys, Germany.;High sensitive-C reactive protein (hs-CRP). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Immunotubercular method using Pars Azmoun kits.;Erythrocyte sedimentation rate (ESR). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Immunotubercular method using Pars Azmoun kits.;Fibrinogen. Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Thrombin-mediated clotting.;Interleukin 6 (IL6). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Colorimetry, using commercial ELISA kits (Bioassay Technology Laboratory, Shanghai, China; E1239Hu) and according to the kit instructions by ELISA machine.;Oxidized-low density lipoprotein cholesterol (OX-LDL-C). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Colorimetry, using commercial ELISA kits (Bioassay Technology Laboratory, Shanghai, China; E1239Hu) and according to the kit instructions by ELISA machine.;Malondialdehyde (MDA). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Colorimetry, using commercial ELISA kits (Bioassay Technology Laboratory, Shanghai, China; E1239Hu) and according to the kit instructions by ELISA machine.;Total antioxidant capacity (TAC). Timepoint: Before the intervention and 3 months after the intervention. Method of measurement: Colorimetry, u

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNoushin Mohammadifard

Esfahan University of Medical Sciences

noushinmohammadifard@gmail.com+98 913 104 6413

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026