Improved lipid profile in hyperlipidemic patients taking Vaccinium arctostaphylos fruit hydroalcoholic extract: a randomized double-blind placebo-controlled clinical trial.

Dyslipidemia is a common contributory cause of cardiovascular disease. Vaccinium arctostaphylos L. (Caucasian whortleberry) fruit is rich of anthocyanins. Anthocyanins may exert cardioprotective effects by various mechanisms such as favorably modulating dyslipidemia. Therefore, in this randomized double-blind placebo-controlled clinical trial with hyperlipidemic (hypercholesterolemic and/or hypertriglyceridemic) patients aged 20-60 years, the effects of taking a standardized whortleberry fruit hydroalcoholic extract (one 350 mg capsule every 8 h for 2 months) on fasting blood levels of lipids, creatinine and liver enzymes including SGOT and SGPT were evaluated in 40 patients and compared with the placebo group (n = 40). The extract lowered the blood levels of total cholesterol (P < 0.001), triglyceride (P = 0.002) and low-density lipoprotein cholesterol (LDL-C) (P = 0.002), but increased the blood high-density lipoprotein cholesterol (HDL-C) levels (P < 0.001) without any significant effects on the blood levels of SGOT, SGPT and creatinine (P > 0.05) compared with the placebo group at the endpoint. Whortleberry reduced total cholesterol, triglyceride and LDL-C 27.6%, 19.2% and 26.3%, respectively, but increased HDL-C 37.5% compared with baseline. No adverse effects were reported. Short-term treatment with whortleberry fruit appears safe and improves lipid profile in hyperlipidemic patients.

Blood pressure lowering effect of Nigella sativa L. seed oil in healthy volunteers: a randomized, double-blind, placebo-controlled clinical trial.

Nigella sativa L. seeds (N. sativa) have been used as a traditional remedy for a wide range of diseases including hypertension. The present study was performed to explore the effects of N. sativa oil on blood pressure (BP) in healthy volunteers. In a double-blind, randomized study, 70 healthy volunteers aged 34 to 63 years with systolic BP from 110 to 140 mmHg and diastolic BP from 60 to 90 mmHg were randomly allocated to receive 2.5 mL N. sativa oil or placebo two times a day for 8 weeks. The systolic and diastolic BPs, body mass index and blood levels of aspartate transaminase, alanine transaminase, alkaline phosphatase, creatinine and blood urea nitrogen were determined at baseline and endpoint. Results showed that in N. sativa oil treated group the systolic and diastolic BPs decreased significantly compared with baseline and placebo group at the endpoint. Other parameters did not significantly change in both groups at the endpoint. No adverse effects were reported. In conclusion, oral daily administration of 5 mL N. sativa oil to healthy volunteers for 8 weeks lowers systolic and diastolic BPs without any adverse effects.

Immunomodulatory effects of saffron: a randomized double-blind placebo-controlled clinical trial.

Saffron is the dried stigmata of the flowers of saffron (Crocus sativus L.). Saffron is rich in carotenoids and carotenoids affect immunity. Thus, in this randomized double-blind placebo-controlled clinical trial with healthy men aged 21.4 ± 0.8 years (mean ± SE), the effects of taking one 100 mg saffron tablet daily for 6 weeks on the blood serum levels of IgG, IgM, IgA, C(3) and C(4) complements, counts and percentages of white blood cells, platelets, neutrophils, eosinophils, basophils, lymphocytes and monocytes, levels of some hematological parameters and levels of creatinine, SGOT and SGPT were evaluated in 45 subjects and compared with the placebo group (n = 44). After 3 weeks, saffron increased the IgG level and decreased the IgM level compared with the baseline and placebo (p < 0.01), decreased the percentage of basophils and the count of platelets compared with baseline, but increased the percentage of monocytes compared with placebo (p < 0.05). However, these parameters returned to the baseline levels after 6 weeks. Saffron did not have any significant effects on the other parameters. No adverse effects were reported. The results suggest that the sub-chronic daily use of 100 mg saffron has temporary immunomodulatory activities without any adverse effects.

Antihyperlipidemic effects of Salvia officinalis L. leaf extract in patients with hyperlipidemia: a randomized double-blind placebo-controlled clinical trial.

Hyperlipidemia is a common metabolic disorder contributing to morbidities and mortalities due to cardiovascular and cerebrovascular diseases. Conventional antihyperlipidemic drugs have limited efficacies and important side effects, so that alternative lipid lowering agents are needed. Salvia officinalis L. (sage) leaves have PPAR γ agonistic, pancreatic lipase and lipid absorption inhibitory, antioxidant, lipid peroxidation inhibitory and antiinflammatory effects. Thus, in this randomized double-blind placebo-controlled clinical trial with 67 hyperlipidemic (hypercholesterolemic and/or hypertriglyceridemic) patients aged 56.4 ± 30.3 years (mean ± SD), the effects of taking sage leaf extract (one 500 mg capsule every 8 h for 2 months) on fasting blood levels of lipids, creatinine and liver enzymes including SGOT and SGPT were evaluated in 34 patients and compared with the placebo group (n = 33). The extract lowered the blood levels of total cholesterol (p < 0.001), triglyceride (p = 0.001), LDL (p = 0.004) and VLDL (p = 0.001), but increased the blood HDL levels (p < 0.001) without any significant effects on the blood levels of SGOT, SGPT and creatinine (p > 0.05) compared with the placebo group at the endpoint. No adverse effects were reported. The results suggest that sage may be effective and safe in the treatment of hyperlipidemia.

Portulaca oleracea L. in the treatment of patients with abnormal uterine bleeding: a pilot clinical trial.

Abnormal uterine bleeding (AUB) is a common cause of referral to the gynecology clinic. Portulaca oleracea L., commonly named purslane, is used in Iranian folk medicine to treat AUB. To verify this use, ten premenopausal women with AUB comprising menorrhagia, metrorrhagia, polymenorrhea and intermenstrual bleeding who had not responded to standard drugs and were candidates for hysterectomy participated in the clinical trial. Endometrial biopsies demonstrated the etiologies of AUB in six (60%) patients, fibroma; one (10%) patient, endometrial hyperplasia and one (10%) patient, endometrial cyst. Endometrial biopsies of two (20%) subjects were normal. The subjects took 5 g of purslane seeds powder in a glass of water every 4 h orally 48 h after the onset of menstruation for 3 days. The participants were requested to report the effects of seeds powder on the volume, duration and pattern of bleeding. Eight (80%) patients reported that the duration and volume of bleeding had reduced and their patterns of periods had normalized. The seeds powder was ineffective in two (20%) patients. One of the patients had endometrial hyperplasia and the other had fibroma. No adverse effects were reported. AUB did not recur in the patients responding to treatment for the duration of a 3 months follow-up. The results suggest that purslane seeds could be effective and safe in the treatment of AUB.

Effects of Nigella sativa L. seed oil on abnormal semen quality in infertile men: a randomized, double-blind, placebo-controlled clinical trial.

In recent years, wide utilization of herbal drugs has encouraged scientists to determine their impressive effects on health. Since Nigella sativa L. seed (N. sativa) has many uses including infertility in traditional medicine, the effects of Nigella sativa L. seed oil on abnormal semen quality in infertile men with abnormal semen quality are of interest. This study was conducted on Iranian infertile men with inclusion criteria of abnormal sperm morphology less than 30% or sperm counts below 20×10(6)/ml or type A and B motility less than 25% and 50% respectively. The patients in N. sativa oil group (n=34) received 2.5mlN. sativa oil and placebo group (n=34) received 2.5ml liquid paraffin two times a day orally for 2 months. At baseline and after 2 months, the sperm count, motility and morphology and semen volume, pH and round cells as primary outcomes were determined in both groups. Results showed that sperm count, motility and morphology and semen volume, pH and round cells were improved significantly in N. sativa oil treated group compared with placebo group after 2 months. It is concluded that daily intake of 5ml N. sativa oil for two months improves abnormal semen quality in infertile men without any adverse effects.

Improved glycemic control and lipid profile in hyperlipidemic type 2 diabetic patients consuming Salvia officinalis L. leaf extract: a randomized placebo. Controlled clinical trial.

OBJECTIVES: Evaluation of the efficacy and safety of Salvia officinalis L. (S. officinalis) leaf extract in the treatment of hyperlipidemic type 2 diabetic patients. DESIGN: Randomized placebo-controlled parallel group study. SETTING: Diabetes Clinic (Karaj City, Alborz Province of Iran). INTERVENTIONS: The efficacy and safety of taking S. officinalis leaf extract (one 500 mg capsule t.i.d. for 3 months) in treatment of 40 hyperlipidemic (hypercholesterolemic and/or hypertriglyceridemic) type 2 diabetic patients were evaluated and compared with the placebo group (n=40). MAIN OUTCOME MEASURES: Fasting blood levels of glucose, glycosylated hemoglobin (HbA1c), total cholesterol, triglyceride, LDL-C (low density lipoprotein cholesterol), HDL-C (high density lipoprotein cholesterol), SGOT (serum glutamic-oxaloacetic transaminase), SGPT (serum glutamic-pyruvic transaminase) and creatinine. RESULTS: The extract lowered fasting glucose, HbA1c, total cholesterol, triglyceride and LDL-C but increased HDL-C compared to baseline at endpoint. Percent difference mean (95% confidence interval) between the extract and placebo groups in terms of effects on fasting glucose, HbA1c, total cholesterol, triglyceride, LDL-C and HDL-C at endpoint were 32.2 (26.5, 37.9), 22.7 (16.8, 28.6), 16.9 (9.7, 24.1), 56.4 (36.1, 76.7), 35.6 (29.9, 41.3) and 27.6 (15.8, 39.4) (P=0.001, P=0.01, P=0.01, P=0.009, P<0.001 and P=0.008), respectively. Moreover, the extract did not have any significant effects on the other parameters compared to the placebo group at endpoint (P>0.05). No adverse effects were reported. CONCLUSIONS: S. officinalis leaves may be safe and have anti-hyperglycemic and lipid profile improving effects in hyperlipidemic type 2 diabetic patients.