Study on efficacy of Vaccinium arctostaphylos in the treatment of hypertensive hyperlipidemic type 2 diabetic patients

Clinical trial comparing the effects of Vaccinium arctostaphylos leaf and fruit extracts with placebo on the blood levels of glycosylated hemoglobin and LDL-cholesterol and amounts of systolic and diastolic blood pressures in the hypertensive hyperlipidemic type 2 diabetic patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201701282288N11

Enrollment

150

Registered

2017-02-12

Start date

2013-04-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Diabetes mellitus. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: Vaccinium arctostaphylos fruit extract at the dose of one 350 mg capsule every 8 hours in addition to standard treatments is administered to a group of 50 patients for 2 months. Interv

Treatment - Drugs

Placebo

Vaccinium arctostaphylos fruit extract at the dose of one 350 mg capsule every 8 hours in addition to standard treatments is administered to a group of 50 patients for 2 months.

Vaccinium arctostaphylos leaf extract at the dose of one 350 mg capsule every 8 hours in addition to standard treatments is administered to a group of 50 patients for 2 months.

One placebo capsule every 8 hours in addition to standard treatments is adminstered to a group of 50 patients for 2 months.

Eligibility

Sex/Gender

All

Age

40 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Iranian male and female hypertensive hyperlipidemic type 2 diabetic outpatients; patients aged 40 to 60 years; patients with blood HbA1c levels between 7% and 9%; patients with fasting blood LDL levels between 100 mg/dL and 150 mg/dL; patients with systolic blood pressures between 14 and 16 mmHg; patients with diastolic blood pressures between 9 and 10 mmHg; patients taking 15 mg glibenclamide, 2 g metformin and 20 mg atorvastatin per day; patients taking synthetic antihypertensive drugs with 3 different mechanisms per day. Exclusion criteria: Patients taking other drugs effective on the blood glucose and lipid levels; patients with cardiac, renal, hepatic, hematological diseases, hypothyroidism, tachycardia, vertigo and seizure; patients with a history of gallstones or gall bladder surgery; pregnant women; women planning pregnancy; breast-feeding women.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Amount of systolic blood pressure. Timepoint: 2 months. Method of measurement: 24-hour ambulatory blood pressure monitoring.;Amount of diastolic blood pressure. Timepoint: 2 months. Method of measurement: 24-hour ambulatory blood pressure monitoring.;Blood level of glycosylated hemoglobin. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of LDL-C. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).	—

Measure

Time frame

Amount of systolic blood pressure. Timepoint: 2 months. Method of measurement: 24-hour ambulatory blood pressure monitoring.;Amount of diastolic blood pressure. Timepoint: 2 months. Method of measurement: 24-hour ambulatory blood pressure monitoring.;Blood level of glycosylated hemoglobin. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of LDL-C. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).

—

Secondary

Measure	Time frame
Blood level of HDL-C. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of total choletsterol. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of SGOT. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of SGPT. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of creatinine. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Fasting blood glucose level. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;2 hour postprandial blood glucose level. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of triglycerides. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).	—

Measure

Time frame

Blood level of HDL-C. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of total choletsterol. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of SGOT. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of SGPT. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of creatinine. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Fasting blood glucose level. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;2 hour postprandial blood glucose level. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).;Blood level of triglycerides. Timepoint: 2 months. Method of measurement: Medical laboratory (kit).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Saeed Kianbakht

ACECR Institute of Medicinal Plants

skianbakht@yahoo.com; kianbakht@imp.ac.ir+98 26 3476 4010

Outcome results

None listed

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