A pilot,randomized, double‐blind,placebo‐controlled trial to assess the safety and efficacy of a novel Boswellia serrata extract in the management of osteoarthritis of the knee

A double‐blind, placebo‐controlled human trial was conducted to evaluate the safety and efficacy of a standardized oral supplementation of Boswellin®, a novel extract of Boswellia serrata extract (BSE) containing 3‐acetyl‐11‐keto‐β‐boswellic acid (AKBBA) with β‐boswellic acid (BBA). A total of 48 patients with osteoarthritis (OA) of the knee were randomized and allocated to the BSE and placebo groups for intervention. Patients were administered BSE or placebo for a period of 120 days. The trial results revealed that BSE treatment significantly improved the physical function of the patients by reducing pain and stiffness compared with placebo. Radiographic assessments showed improved knee joint gap and reduced osteophytes (spur) confirming the efficacy of BSE treatment. BSE also significantly reduced the serum levels of high‐sensitive C‐reactive protein, a potential inflammatory marker associated with OA of the knee. No serious adverse events were reported. This is the first study with BSE conducted for a period of 120 days, longer than any other previous clinical trial on patients with OA of the knee. The findings provide evidence that biologically active constituents of BSE, namely, AKBBA and BBA, act synergistically to exert anti‐inflammatory/anti‐arthritic activity showing improvement in physical and functional ability and reducing the pain and stiffness.     

A double‐blind,randomized, placebo‐controlled study to assess the efficacy of Andrographis paniculata standardized extract (ParActin®) on pain reduction in subjects with knee osteoarthritis

Andrographis paniculata Wall (Acanthaceae) is becoming more recognized for its anti‐inflammatory and antioxidant properties. A randomized, double‐blind, placebo‐controlled study was conducted to assess the efficacy of an andrographolide‐containing supplement, ParActin® (300 and 600 mg daily), on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain reduction in patients with knee osteoarthritis. Joint stiffness, physical function, changes in the SF‐36 quality of life questionnaire, a fatigue scale, and safety were also evaluated. A total of 103 male and female patients with I‐II osteoarthritis of the knee joint were assessed. Patients treated with 300 or 600 mg/day of ParActin® showed a significant reduction in pain at days 28, 56, and 84 compared with a placebo group. WOMAC stiffness scores, physical function score, and the fatigue score showed a significant improvement in both ParActin®‐treated groups compared with the placebo group. At the end of the study, the quality of life (SF‐36 questionnaire) and Functional Assessment of Chronic Illness Therapy (FACIT) scores showed significant improvements in both ParActin®‐treated groups compared with the placebo group. Overall, it can be concluded that ParActin® in 300 and 600 mg/day dosages were found to be effective and safe in reducing pain in individuals suffering from mild to moderate knee osteoarthritis.     

The efficacy of topical red clover oil on knee osteoarthritis: A pilot prospective randomized triple‐blind placebo‐controlled clinical trial

A triple‐blind placebo‐controlled clinical trial was performed to evaluate the efficacy of topical red clover oil (containing standardized red clover extract in olive oil) on knee osteoarthritis (OA). A total of 80 patients, 50–80 years old, with primary knee OA were randomly allocated to two groups. The study group used topical red clover oil and the control group used olive oil for 4 weeks (20 drops twice a day). Both groups adhered to nonpharmacological American College of Rheumatology recommendations and took meloxicam tablets during the study (0–8 weeks), and were followed up from Week 4 to 8. Efficacy measures were evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and Visual Analogue Scale (VAS). At baseline, both groups were homogeneous regarding demographic characteristics. In addition, they were asked about the side effects during the intervention. The results showed that the WOMAC score and its subscales of pain and stiffness and function scores and VAS significantly increased over time in both groups (p < .001). The study group showed a significant increase regarding pain (p = .001), function (p = .010), VAS (p < .001), and the WOMAC total score (p = .018). No serious drug side effects were observed. Red clover oil may have positive effects on symptoms of knee OA and can be considered as a complementary treatment.     

Efficacy of black seed (Nigella sativa L.) on kidney stone dissolution: A randomized,double‐blind,placebo‐controlled,clinical trial

Preclinical studies have shown beneficial effects of black seed (Nigella sativa L.) in the prevention and treatment of renal stones. Hence, we designed a study to evaluate the renal‐stone‐dissolving efficacy of black seed. Sixty patients with renal stones were randomly enrolled in two arms of a randomized, triple‐blind, placebo‐controlled, clinical trial. The patients were treated by black seed capsules (500 mg) or placebo two times per day for 10 weeks. Patients were assessed in terms of size of renal stones by using sonography before and after intervention. In the black seed group, 44.4% of patients excreted their stones completely, and the size of the stones remained unchanged and decreased in 3.7% and 51.8% of patients, respectively. In contrast, in the placebo group, 15.3% of the patients excreted their stones completely, 11.5% had reduction in stone size, 15.3% had increase in stone size, and 57.6% had no change in their stone size. The difference in the mean size of renal stones after the study was significant between the two groups (p < 0.05). N. sativa L., as compared with placebo, is demonstrated to have significant positive effects on disappearance or reduction of size of kidney stones.     

The effects of black seed supplementation on cardiovascular risk factors in patients with nonalcoholic fatty liver disease: A randomized,double‐blind,placebo‐controlled clinical trial

Nonalcoholic fatty liver disease (NAFLD) is highly related to cardiovascular disorders risk factors. This study aimed to evaluate the effects of black seed (Nigella sativa) supplementation on cardiovascular disorders risk factors in patients with NAFLD. This randomized, double‐blind, placebo‐controlled clinical trial was conducted on 50 patients with NAFLD. Participants were assigned to receive a lifestyle modification plus 2 g/day of either N. sativa or placebo for 12 weeks. Compared with the placebo, N. sativa supplementation led to significant reductions in serum glucose (?7.95 vs. ?1.22; p = .041), serum insulin (?3.87 vs. ?1.07; p = .027), homeostatic model of assessment for insulin resistance (?1.02 vs. ?0.28; p = .021), and a significant increase in quantitative insulin sensitivity check index (0.03 vs. 0.006; p = .002). All of these changes were remained significant after adjusting for known confounding variables; however, there was no significant difference in lipid profile changes between the two groups (p = .05). N. sativa supplementation significantly decreased hepatic steatosis percentage compared with the placebo after adjustment for confounding variables (p = .005). In conclusion, our results indicate that daily intake of 2‐g N. sativa plus lifestyle modification is superior to lifestyle modification alone in amelioration of insulin resistance and hepatic steatosis in patients with NAFLD.     

Supplementation with Cynanchum wilfordii radix extract for 8 weeks lowers serum total cholesterol: A controlled,randomized, double‐blind clinical trial

This trial aimed to determine the effect of a standardized Cynanchum wilfordii Radix extract (CWE) on the lipid profiles of individuals with elevated total cholesterol (T‐Chol) using a double‐blind randomized placebo‐controlled design. Ninety‐six Korean individuals with elevated T‐Chol level (200–240 mg/dL) were recruited and randomly allocated to groups that received VasH300 (300 mg CWE/day, n = 32), VasH600 (600 mg CWE/day, n = 32), or a placebo (n = 32) groups. Primary outcomes included T‐Chol, low‐density lipoprotein (LDL)‐cholesterol, high‐density lipoprotein (HDL)‐cholesterol, triglyceride, and safety (adverse events, biochemical parameters, and hematological parameters). Data were compared using a one‐way analysis of variance followed by Duncan's post‐hoc tests (among groups) and paired t tests (within groups). Values for T‐Chol and LDL‐cholesterol were significantly reduced in the VasH300 and groups (VasH300: 4.0 and 6.4%, respectively; VasH600; 3.8 and 5.8% respectively; both p < .05) compared with the placebo group and were not dose‐dependent. VasH300 significantly improved the lipid profiles of individuals with elevated T‐Chol without any serious side effects. Daily supplementation with VasH might be an alternative strategy with which to modify cholesterol‐related parameters, especially in individuals with elevated T‐Chol levels.     

Efficacy and safety of Sophora alopecuroides var. alopecuroides seed extract for opioid detoxification: A randomized,double‐blind,and placebo‐controlled clinical trial

The seeds of Sophora alopecuroides L. var. alopecuroides (S. alopecuroides) have alleviated morphine withdrawal in mice. Therefore, in this study, the alkaloid composition of S. alopecuroides extract was determined by gas chromatography (GC) and gas chromatography–mass spectrometry (GC–MS) analysis. Moreover, 50 abstinent opium addicts consumed three 400 mg extract capsules once daily and 50 other patients took placebo for 8 days. At the baseline and days 3 and 8, the clinical opiate withdrawal scale (COWS) was used to assess withdrawal symptoms. At the baseline and Day 8, the patients' blood levels of serum glutamate oxaloacetate transferase; serum glutamate pyruvate transferase; alkaline phosphatase; total, direct, and indirect bilirubins; creatinine and blood urea nitrogen; complete blood count; and prothrombine time were measured. The groups' parameter values were also compared. Sophocarpine, matrine, and sophoramine were the major alkaloids constituting, respectively, 32.85, 26.55, and 6.91% of the extract. The extract decreased the COWS score at Days 3 and 8 significantly compared with the placebo (p < .001). The extract did not significantly affect the blood parameters' values compared with the placebo (p > .05). There was no adverse drug effect. In conclusion, the extract reduces the acute opioid withdrawal symptoms and seems to have good safety and tolerability.     

Beneficial effects of nano‐curcumin supplement on depression and anxiety in diabetic patients with peripheral neuropathy: A randomized,double‐blind,placebo‐controlled clinical trial

Depression in patients with diabetes is associated with poor glycemic control and linked to an increased risk for diabetes complications such as neuropathy. Curcumin has shown potential antidepressant‐like activities in some studies. The present study is the first randomized controlled trial to test the efficacy of nano‐curcumin supplementation on depression, anxiety, and stress in patients with diabetic polyneuropathy. Eighty patients with diabetes were enrolled in this parallel, double‐blind, randomized, placebo‐controlled clinical trial. The participants were allocated randomly to the intervention (n = 40) and control (n = 40) groups. They received 80 mg of nano‐curcumin or placebo capsules daily for 8 weeks. At baseline and end of study, anthropometric measurements, dietary intake, physical activity, glycemic indices, and severity of neuropathy were assessed. The depression, anxiety, and stress level were measured by Depression, Anxiety, Stress Scale (DASS‐21‐items) questionnaire before and after the intervention. After intervention, there was a significant reduction in the mean score of depression in the nano‐curcumin group (from 16.7 [3.1] to 15.3 [2.6]) compared with placebo group (17.5 [3.2] to 17.3 [3.1]; p = .02). In addition, a significant fall was found in the mean score of anxiety in the nano‐curcumin group (from 22.4 [4.03] to 20.6 [3.4]) compared with the placebo group (21.9 [3.5] to 21.2 [3.5]; p = .009). Changes in stress score were not statistically significant between the two groups. These findings suggested that nano‐curcumin supplementation for 8 weeks was effective in reducing depression and anxiety scores in patients with diabetic polyneuropathy.     

Beneficial effects of Codonopsis lanceolata extract on systolic blood pressure levels in prehypertensive adults: A double‐blind,randomized controlled trial

Codonopsis lanceolata (CL) extract was shown to have antihypertensive effects in hypertensive rats. This randomized controlled trial was designed to investigate the ability of CL extract to prevent hypertension (HTN) in prehypertensive subjects. Eighty subjects aged 19–60 years with a systolic blood pressure (BP) of 120–139 mmHg and a diastolic BP of 80–89 mmHg were recruited over 3 months. Subjects were randomized 1:1 to a CL group and a placebo (PL) group and administered CL extract and starch, respectively, for 6 weeks. (BP) was measured and blood sampled at baseline and at the end of the trial. Relative to baseline, systolic BP was significantly decreased, and catalase activity was significantly increased following CL treatment in both the elevated systolic BP and stage 1 HTN subgroups. In the elevated systolic BP subgroup, serum nitrite concentration relative to baseline was significantly increased in CL compared to PL treated subjects (p = .038). In subjects with stage 1 HTN, high sensitivity C‐reactive protein (p = .020) and malondialdehyde (p = .039) showed significantly greater reductions from baseline in the CL than in the PL group. In summary, CL was effective in preventing endothelial dysfunction, inflammation, and lipid peroxidation in prehypertensive subjects, with these effects differing according to baseline systolic BP levels.     

Aloysia citriodora Palau (lemon verbena) for insomnia patients: A randomized,double‐blind,placebo‐controlled clinical trial of efficacy and safety

Aloysia citriodora (A. citriodora) has a long history of traditional use for sedation and treatment of insomnia in different societies. This study was carried out to assess the efficacy of A. citriodora in patients with insomnia. One hundred patients were randomly divided into two groups of A. citriodora (total essential oil 1.66 mg/10 ml and total amount of flavonoid in terms of quercetin 3.22 mg/10 ml of the syrup) and placebo. They were advised to use 10 cc of the syrups; an hour before the bedtime for a period of 4 weeks. Participants were assessed using Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) questionnaires at the baseline and then 2 and 4 weeks after the enrollment. Mean scores of global PSQI and its four components including sleep latency, habitual sleep efficiency, daytime dysfunction, and subjective sleep quality and also ISI score in the A. citriodora group improved significantly after 4 weeks of treatment when compared with the placebo group (p < 0.001, for all of them). Also, improvement of global score of PSQI and ISI was observed in the intervention group as compared with the placebo group, 2 weeks after the enrollment (p < 0.001). The results of this study showed that oral intake of A. citriodora can be suggested as a complementary treatment for patients with insomnia.     

An investigation of the effects of curcumin on iron overload,hepcidin level,and liver function in β‐thalassemia major patients: A double‐blind randomized controlled clinical trial

This study investigated the effects of curcumin, the active polyphenol in turmeric, on iron overload, hepcidin level, and liver function in β‐thalassemia major patients. This double‐blind randomized controlled clinical trial was conducted on 68 β‐thalassemia major patients. The subjects were randomly divided into 2 groups to receive either 500 mg curcumin capsules (total: 1,000 mg) twice daily or placebo for 12 weeks. Dietary intakes and biochemical variables including hemoglobin, transferrin saturation, total iron binding capacity, nontransferrin bound iron (NTBI), ferritin, hepcidin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were assessed at the beginning and end of the trial. Curcumin significantly reduced serum levels of NTBI (2.83 ± 1.08 compared with 2.22 ± 0.97 μmol/L, p = .001), ALT (42.86 ± 11.15 compared with 40.60 ± 9.89 U/L, p = .018), and AST (49.45 ± 12.39 compared with 46.30 ± 10.85 U/L, p = .002) at the end of the study. Based on analysis of covariance, a significant decrease was also observed in levels of NTBI (2.22 ± 0.97 vs. 2.55 ± 0.94 μmol/L, p = .026), ALT (40.60 ± 9.89 vs. 45.01 ± 10.42 U/L, p = .004), and AST (46.30 ± 10.85 vs. 50.99 ± 9.36 U/L, p = .009) in curcumin group in comparison with placebo group. There were no significant changes in hepcidin and other variables in any of the 2 groups. Curcumin administration alleviated iron burden and liver dysfunction by reducing NTBI, ALT, and AST levels in patients with β‐thalassemia major.

     

The effect of saffron supplement on clinical outcomes and metabolic profiles in patients with active rheumatoid arthritis: A randomized,double‐blind,placebo‐controlled clinical trial

Rheumatoid arthritis (RA) is a systemic autoimmune and inflammatory disease. Our study aimed to determine the effect of saffron supplement on clinical outcomes and metabolic profiles in patients with active RA. In this randomized, double‐blind, placebo‐controlled trial, 66 women older than 18 years old received 100 mg/day either saffron supplement in the intervention group (n = 33) or matched placebo in the placebo group (n = 33) for a period of 12 weeks. Sixty‐one patients (30 in the control and 31 in the saffron group) remained for the final analysis. No adverse effects were reported by the patients. Saffron supplementation significantly decreased the number of tender (?1.38 ± 1.66 vs. 0.10 ± 0.40, p < .001) and swollen (?2.12 ± 2.34 vs. 0.63 ± 2.79, p < .001) joints, pain intensity based on visual analogue scale (?18.36 ± 15.07 vs. ?2.33 ± 5.04), p < .001), and disease activity score (DAS28) (?0.75 ± 0.67 vs. 0.26 ± 0.77, p < .001) at the end of intervention between the two groups and in saffron group compared with baseline values. Physician Global Assessment (p = .002) and erythrocyte sedimentation rate were significantly improved after intervention (24.06 ± 12.66 vs. 32.00 ± 14.75, p = 0.028). High‐sensitivity C‐reactive protein reduced at the end of the intervention in the saffron group compared with baseline values (12.00 ± 7.40 vs. 8.82 ± 7.930, p = .004). Tumor necrosis factor alpha, interferon gamma, and malondialdehyde were decreased, and total antioxidant capacity were increased, but their differences between the two groups were not significant (p > .05). According to the results, saffron supplements could positively and significantly improve clinical outcomes in RA patients.     

The effects of lycopene supplement on the spermatogram and seminal oxidative stress in infertile men: A randomized,double‐blind,placebo‐controlled clinical trial

Infertility is a major, worldwide problem that is affected, and mediated, by several factors, in particular, oxidative stress. Thus, the aim of this study was to evaluate the effect of lycopene supplementation on spermatogram and seminal oxidative stress. In this randomized, double‐blind, placebo‐controlled trial study, 44 infertile men with oligozoospermia were randomly divided into two groups: The experimental group was supplemented with 25 mg of lycopene, and the control group received placebo for 12 weeks. Anthropometric, physical activity and dietary assessment, semen analysis, total antioxidant capacity (TAC), malondialdehyde, and glutathione peroxidase were measured pre‐ and post‐intervention. At the end of the study, there was a significant increase in total sperm count and concentration in the lycopene group, and the latter total count remained significant after adjustment (p < .05). Intragroup analysis showed a significant increase in ejaculate volume, total sperm count, concentration total motility, nonprogressive, and nonmotility in lycopene group (p < .05). The TAC changes, in both groups, remained significant after adjustment (p < .05). Also, within‐group analysis showed a significant increase in TAC levels (p < .05). Lycopene supplement can improve sperm parameters and oxidative stress biomarkers in oligozoospermia infertile men; however, further studies with larger sample size and duration are required.     

The effects of curcumin supplementation on high‐sensitivity C‐reactive protein,serum adiponectin,and lipid profile in patients with type 2 diabetes: A randomized,double‐blind,placebo‐controlled trial

Diabetes mellitus is one of the most common and important metabolic diseases in human. Curcumin, which is a natural polyphenol found in turmeric, can be used in treatment of diabetes complications for its antidiabetic, anti‐inflammatory, and antioxidant properties. In this double‐blind randomized clinical trial, 44 patients with Type 2 diabetes randomly assigned to curcumin or placebo group. Patients consumed either 1,500‐mg curcumin or placebo daily for 10 weeks. Anthropometric measurements were measured at baseline and at the end of the study. Serum concentrations of triglyceride (TG), total cholesterol, high‐density lipoprotein cholesterol, low‐density lipoprotein cholesterol, high‐sensitivity C‐reactive protein, and adiponectin were determined after 12‐hr fasting at the beginning and end of study. The mean serum level of TG decreased in curcumin group compared with baseline (109 ± 36 vs. 124 ± 36; p < 0.05). At the end of study, the mean concentration of high‐sensitivity C‐reactive protein decreased in the curcumin group compared to the control (2.9 ± 2.9 vs. 3.4 ± 4.2; p < 0.05). The mean serum concentration of adiponectin increased (64 ± 3 vs. 63 ± 4; p < 0.05) in the treatment group compared with the placebo at the end of the study. The results of the current study indicate that curcumin consumption may reduce diabetes complications through decreasing TG level as well as indicators of inflammation.     

The effect of hydroalcoholic Saffron (Crocus sativus L.) extract on fasting plasma glucose,HbA1c,lipid profile,liver, and renal function tests in patients with type 2 diabetes mellitus: A randomized double‐blind clinical trial

Diabetes mellitus is a metabolic disease that manifested as hyperglycemia due to the defect in secretion or function of insulin. Studies have shown that saffron and its derivatives cause a significant reduction in plasma glucose levels in experimental models. The purpose of this study was to investigate the effect of the saffron extract on fasting plasma glucose (FPG), glycated hemoglobin level (HbA1c), lipid profile, liver enzymes, and renal function tests in type 2 diabetic patients. In this double‐blind randomized clinical trial, 64 type 2 diabetic patients who were on oral anti‐diabetic drugs were examined. Participants received either 15 mg of saffron or placebo capsules (two pills per day) for 3 months. Anthropometric indices, dietary intake, FPG, HbA1c, lipid profiles, liver enzymes (ALT, AST, ALP), and renal function (BUN, Cr.) tests were measured pre and post intervention after 3 months. Independent t test and paired t test were used for data analysis. After 3‐months intervention, mean difference of FPG, Cholesterol, LDL‐c, and LDL/HDL ratio between two groups showed significant reduction(p < 0.0001), but HbA1c, HDL‐C, API, TG showed no significant differences (p > 0.05). In saffron group, FPG, HbA1c, cholesterol, LDL‐c, and LDL/HDL ratio decreased significantly after 3‐months intervention compare with baseline (p < 0.0001).     

Effect of sour tea supplementation on liver enzymes,lipid profile,blood pressure,and antioxidant status in patients with non‐alcoholic fatty liver disease: A double‐blind randomized controlled clinical trial

The aim of this study was to evaluate the efficacy of sour tea supplementation in patients with nonalcoholic fatty liver disease (NAFLD). Seventy NAFLD patients were enrolled in this randomized, double‐blind, placebo‐controlled clinical trial. Participants received sour tea in the form of a 450 mg capsule or a placebo capsule daily for 8 weeks. Anthropometric indices, liver enzymes, lipid profile, blood pressure, and antioxidant status were evaluated at the baseline and at the end of the study. Sixty‐one participants completed the study. After 8 weeks, sour tea administration significantly decreased serum triglyceride (TG) (p = .03), alanine aminotransferase (ALT) (p = .01), and aspartate aminotransferase (AST) (p = .004) levels compared with the placebo. In addition, sour tea supplementation resulted in a significant reduction in systolic blood pressure (SBP) (p = .03) and diastolic blood pressure (DBP) (p = .04), and a significant increase in serum total antioxidant capacity (TAC) levels (p ? .001) compared with the placebo. However, no significant changes in anthropometric measures, total cholesterol (TC), low‐density lipoprotein cholesterol (LDL‐c), and high‐density lipoprotein cholesterol (HDL‐c) levels were observed after sour tea supplementation compared with the placebo (p > .05). Sour tea supplementation may be effective in improving serum TG, liver enzymes, and blood pressure in patients diagnosed with NAFLD. Further studies are needed to address the exact mechanism of action of these effects.     

The effect of l‐carnitine supplementation on serum levels of omentin‐1, visfatin and SFRP5 and glycemic indices in patients with pemphigus vulgaris: A randomized,double‐blind,placebo‐controlled clinical trial

Pemphigus vulgaris (PV) is a chronic autoimmune disorder with potentially fatal outcomes. The aim of this study was to investigate the effect of l ‐carnitine (LC) on secreted frizzled‐related protein‐5 (SFRP5), omentin, visfatin, and glycemic indices in PV patients under corticosteroid treatment. In this randomized, double‐blind, placebo‐controlled clinical trial, 52 patients with PV were divided randomly into two groups to receive 2 g of LC or a placebo for 8 weeks. Serum levels of SFRP5, omentin, visfatin, and also glycemic indices were evaluated at the baseline and end of the study. LC supplementation significantly decreased the serum level of visfatin (95% CI [?14.718, ?0.877], p = .05) and increased the serum levels of SFRP5 (95%CI [1.637, 11.380], p < .006) and omentin (95% CI [9.014, 65.286], p < .01). However, LC supplementation had no significant effects on the serum levels of glycemic factors such as insulin (95% CI [?1.125, 3.056], p = .426), fasting blood sugar (95% CI [?4.743, 3.642], p = .894), homeostatic model assessment of insulin resistance (95% CI [?0.305, 0.528], p = .729), and quantitative insulin‐sensitivity check index (95% CI [?0.016, ?0.010], p = .81). LC supplementation decreased visfatin serum level and increased omentin‐1 and SFRP5 serum levels in patients with PV. However, it has no significant effect on the serum levels of insulin and glycemic indices.     

Efficacy of Melissa officinalis L. (lemon balm) extract on glycemic control and cardiovascular risk factors in individuals with type 2 diabetes: A randomized,double‐blind,clinical trial

Melissa officinalis is a plenteous source of antioxidant flavonols and flavonoids that contain health‐promoting and antidiabetic properties, so this study was undertaken to provide the first assessment of the antidiabetic properties of hydroalcoholic extract of M. officinalis in type 2 diabetic patients. We did a randomized, placebo‐controlled trial which included 62 patients, receiving either M. officinalis capsules (700 mg/d; n = 31) or the placebo (n = 31) twice daily for 12 weeks. There were significant differences in serum FBS (P = 0.007), HbA_1c (P = 0.002), β‐cell activity (P = 0.05), TG (P = 0.04), HDL‐c (P = 0.05), hs‐CRP (P = 0.001), and systolic blood pressure (P = 0.04) between the two groups at the end of the study; but total cholesterol, LDL‐c, insulin, and HOMA‐IR showed no significant changes between the groups. In M. officinalis group, there was a significant change in HDL‐c (P = 0.009) and QUICKI (P = 0.005) compared with baseline values. No adverse effects were observed. It seems that M. officinalis is safe and effective in improvement of lipid profile, glycemic control, and reduction of inflammation.     

Effects of crocin and saffron aqueous extract on gene expression of SIRT1, AMPK,LOX1, NF‐κB,and MCP‐1 in patients with coronary artery disease: A randomized placebo‐controlled clinical trial

This trial evaluated the potential impacts of saffron aqueous extract (SAE) and its main carotenoid on some of the atherosclerosis‐related gene expression and serum levels of oxidized low‐density cholesterol (ox‐LDL) and Monocyte chemoattractant protein 1 (MCP‐1) in patients with coronary artery disease (CAD). Participants of this randomized controlled trial included 84 CAD patients who categorized into three groups: Group 1 received crocin (30 mg/day), Group 2 SAE (30 mg/day), and Group 3 placebo for 8 weeks. Gene expression of Sirtuin 1 (SIRT1), 5'‐adenosine monophosphate‐activated protein kinase (AMPK), Lectin‐like oxidized LDL receptor 1 (LOX1), nuclear factor kappa‐light‐chain‐enhancer of activated B cells (NF‐κB), and MCP‐1 in peripheral blood mononuclear cells assessed by real‐time PCR. Furthermore, serum ox‐LDL and MCP‐1 levels measured at the beginning and end of the intervention. Compared with the placebo group, gene expression of SIRT1 and AMPK increased significantly in the crocin group (p = .001), and the expression of LOX1 and NF‐κB decreased significantly (p = .016 and .004, respectively). Serum ox‐LDL levels decreased significantly in the crocin group after the intervention (p = .002) while MCP‐1 levels decreased both in crocin and SAE groups (p = .001). Crocin may have beneficial effects on CAD patients by increasing the gene expression of SIRT1 and AMPK and decreasing the expression of LOX1 and NF‐κB.