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Evaluation of Effect of Internal Septum of Walnut on Blood Lipids

Initial Evaluation of Effect of Internal Septum of Juglans regia L. on Blood Lipids in Patients with Dyslipidemia: A Double-blind Placebo-controlled Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201227049850N1
Enrollment
60
Registered
2021-10-03
Start date
2021-07-23
Completion date
Unknown
Last updated
2022-01-11

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

Conditions

Dyslipidemia. Hyperlipidemia, Unspecified

Interventions

Intervention 1: Intervention group: The intervention group is treated with an oral capsule containing 500 mg of internal septum of Juglans regia L. extract three times a day for 12 weeks. Intervention

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

Inclusion criteria: Obtain informed consent from patients. Patients aged 25 to 70 years. Patients with dyslipidemia who have serum LDL-C more than goal based on European Heart Association 2019 guideline despite receiving the maximum or maximum tolerable dose of statins. The therapeutic goals of LDL-C blood levels varies between 55 and 100 mg/dl based on other conditions and diseases in the study participants.

Exclusion criteria

Exclusion criteria: History of walnut allergy Taking other herbal medicines Immune system defects Pregnancy Renal failure (eGFR × 3 ULN) Uncontrolled thyroid disease (TSH 1.5 × ULN) TG>350 mg/dl Concomitant use of any medication containing estrogen or progesterone, systemic glucocorticoids, cyclosporine, tacrolimus, everolimus, sirolimus, antipsychotic drugs, psychotropic substances or alcohol Neurological or psychiatric disorders that affect the acceptance of medication and the correct implementation of the study protocol Lactation

Design outcomes

Primary

MeasureTime frame
Low-density lipoprotein cholesterol (LDL-C). Timepoint: Zero and 12 weeks after intervention. Method of measurement: Serum level measurement.

Secondary

MeasureTime frame
Serum level of lipoprotein(a). Timepoint: Zero and 12 weeks after intervention. Method of measurement: Serum level measurement.;Serum level of triglycerides. Timepoint: Zero and 12 weeks after intervention. Method of measurement: Serum level measurement.;Serum level of total cholesterol. Timepoint: Zero and 12 weeks after intervention. Method of measurement: Serum level measurement.;Cholesterol ratio(low-density lipoprotein cholesterol/high-density lipoprotein cholesterol). Timepoint: Zero and 12 weeks after intervention. Method of measurement: Calculate Low Density lipoprotein cholesterol divided by high Density lipoprotein cholesterol.;Atherogenic index (log triglycerides/high-density lipoprotein). Timepoint: Zero and 12 weeks after intervention. Method of measurement: Calculate the logarithm of high-density lipoprotein cholesterol divided by triglyceride.;Weight, waist and waist to hip. Timepoint: Zero and 12 weeks after intervention. Method of measurement: Measurement with a meter.;Systolic and diastolic blood pressure. Timepoint: Zero and 12 weeks after intervention. Method of measurement: By blood pressure monitor device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSoha Namazi

Tehran University of Medical Sciences

namazisoha@yahoo.com+98 21 4441 2540

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 11, 2026