A randomized, double-blind placebo-controlled add-on trial to assess the efficacy, safety, and anti-atherogenic effect of spirulina platensis in patients with inadequately controlled type 2 diabetes mellitus.

The efficacy of spirulina platensis (S. platensis) as an add-on therapy to metformin and its effect on atherogenic keys in patients with uncontrolled Type 2 Diabetes Mellitus (T2DM) was evaluated. Sixty patients were randomly assigned to S. platensis (2 g/day) or placebo group for three months while continuing metformin as their usual treatment. The efficacy of S. platensis was determined using the pre- and post-intervention HbA1c levels (primary outcome) as well as tracking FBS and lipid profiles levels (TC, LDL-C, TG, and HDL-C) as secondary outcomes at the different treatment time points (0,30,60,90 days). During the three-month intervention period, supplementation with S. platensis resulted in a significant lowering of HbA1c (↓1.43, p < 0.001) and FBS (↓ 24.94 mg/dL, p < 001) levels. Mean TG in the intervention group was found to be significantly lower in the intervention group than in controls (p < 0.001). Total cholesterol (TC) and its fraction, LDL-C, exhibited a fall (↓41.36 mg/dL and ↓38.4 mg/dL, respectively; p < 0.001) coupled with a marginal increase in the level of HDL-C (↑3 mg/dL; p < 0.001). Add-on therapy with S. platensis was superior to metformin regarding long-term glucose regulation and controlling blood glucose levels of subjects with T2DM. Also, as a functional supplement, S. platensis has a beneficial effect on atherogenic keys (TG and HDL-C) with no adverse events.

Comparative evaluation of the protective effects of oral administration of auraptene and umbelliprenin against CFA-induced chronic inflammation with polyarthritis in rats.

This study aimed to evaluate the anti-inflammatory effect of Auraptene (AUR) and Umbelliprenin (UMB) in a rat model of rheumatoid arthritis (RA) induced by using complete Freund's adjuvant (CFA). Paw swelling of adjuvant arthritis rats measured at various times after CFA injection. Over 15 days of RA induction, mediator/cytokine-mediated processes involved in managing the regulation and resolving RA's inflammation were also quantified with ELISA. Histopathological changes were also assessed under a microscope 15 days after the CFA injection. AUR at all doses and UMB administration only at a 16 mM /kg administration dose significantly reduced CFA-induced paw edema level compared to the control group. UMB (64 and 32 mM) and AUR (64, 32, and 16 mM) could reduce the PGE2 (p < .0001-.01) and NO (p < .0001-.05) levels in the treatment groups compared to the negative control group. However, these compounds showed no significant effect on the TNF-α, IFN-γ, TGF-ß, IL-4, and IL-10 levels than the control group (p > .05). Unlike indomethacin and prednisolone, treatment of rats with AUR (16, 32, and 64 mM/kg) and UMB (16 and 32 mM/kg) reduced the level of IL-2 (p < .0001). In all treatment groups, the serum level of IL-17 was significantly reduced compared to the CFA group (p < .001-0.05). We suggested AUR and UMB could diminish inflammation by reducing the serum level of IL-17 and could be considered a proper alternative in the treatment of IL-17 related inflammatory diseases such as rheumatoid arthritis. Given that AUR and UMB apply their anti-inflammatory effects by changing distinct cytokine release/inhibition patterns, their potential application in diverse inflammatory diseases seems different.

A randomized, double-blind, placebo-controlled, clinical trial to evaluate the benefits of Nigella sativa seeds oil in reducing cardiovascular risks in hypertensive patients.

The efficacy, safety, and utility of Nigella sativa seeds oil as a complementary treatment for hypertension, glucose control, and lipid metabolism were evaluated. Hypertensive patients in the intervention (n = 26) and placebo (n = 29) groups received 2.5 ml of N. sativa seeds oil and sunflower oil twice daily for 8 weeks, respectively. The levels of systolic and diastolic blood pressure (SBP, DBP), blood lipid profile, and fasting blood sugar (FBS), at different stages of the treatment period (0, 3, 6, 8 weeks), and malondialdehyde (MDA) and glutathione reductase (GR), at the baseline and end of the study, were assessed. SBP level in the intervention group was significantly reduced, compared with the baseline values (p < .001) and the placebo group (p < .05). A significant decline was observed in the levels of DBP, total cholesterols, and low density lipoprotein (LDL) (p < .000), MDA, and FBS (p < .001); also, a significant increase was observed in the levels of high density lipoprotein (HDL) and GR (p < .001). The use of N. sativa seeds oil as an adjunct to common medications exhibited additional antihypertensive effects as well as beneficial effects on glucose control and lipid metabolism in hypertensive patients with no renal, hepatic, and patient-reported adverse events.

Oral nano-curcumin formulation efficacy in management of mild to moderate hospitalized coronavirus disease-19 patients: An open label nonrandomized clinical trial.

Curcumin is proposed as a potential treatment option for coronavirus disease-19 (COVID-19) by inhibiting the virus entrance, encapsulation and replication, and modulating various cellular signaling pathways. In this open-label nonrandomized clinical trial, efficacy of nano-curcumin oral formulation has been evaluated in hospitalized patients with mild-moderate COVID-19. Forty-one patients who fulfilled the inclusion criteria were allocated to nano-curcumin (n = 21) group (Sinacurcumin soft gel, contains 40 mg curcuminoids as nanomicelles, two capsules twice a day) or control (n = 20) group, for 2 weeks. Patients' symptoms and laboratory data were assessed at baseline and during follow-up period. Most of symptoms including fever and chills, tachypnea, myalgia, and cough resolved significantly faster in curcumin group. Moreover, SaO2 was significantly higher in treatment group after 2, 4, 7, and 14 days of follow-up and lymphocyte count after 7 and 14 days. Duration of supplemental O2 use and hospitalization was also meaningfully shorter in treatment group. It is also noteworthy to mention that no patient in treatment group experienced deterioration of infection during follow-up period, but it occurred in 40% of control group. Oral curcumin nano-formulation can significantly improve recovery time in hospitalized COVID-19 patients. Further randomized placebo controlled trials with larger sample size are recommended.

Evaluation of sedative effects of an intranasal dosage form containing saffron, lettuce seeds and sweet violet in primary chronic insomnia: A randomized, double-dummy, double-blind placebo controlled clinical trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Persian Medicine (TPM) has been established as a valuable source of medicinal plants for the treatment of insomnia for thousands of years. Accordingly, oil extracts from plants' parts have been widely used to alleviate central nervous system (CNS) ailments including sleep disorders. A number of preparations have been recommended by TPM for the treatment of insomnia. Among them, an intranasal formulation containing oily macerates of Viola odorata L., Crocus sativus L. and Lactuca sativa L. stands out. AIM OF THE STUDY: In the present double-dummy, double-blind placebo controlled clinical trial, we aim to evaluate the effectiveness of a combination of violet oil, saffron oil, and lettuce seeds oil nasal drop compared with the placebo (sesame oil). MATERIALS AND METHODS: Fifty patients with primary chronic insomnia were randomly assigned in TPM-treatment or placebo groups, received either two drops of the herbal oil or placebo into each nostril every noon and evening for 8 weeks. Before the study commencement and after 1, 4 and 8 weeks of treatment, Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires were completed by all patients. The primary outcome measure was considered as any changes in ISI scores between the first visit and after 8 weeks. Changes in PSQI scores during the study and possible side effects were also assessed. The multicompound herbal oil was standardized using HPLC analysis and contained 0.02 mg/mL crocin and 4 µg/mL isoquercitrin. RESULTS: Our study revealed a significant reduction in the ISI and PSQI scores from baseline by the study endpoint (P ≤ 0.01). The mean ISI scores in week 8 decreased significantly for the intervention group (P = 0.001) and also the placebo group (P < 0.01) when compared with baseline. Moreover, the use of hypnotic drugs in the intervention group was significantly reduced (P < 0.001), while in the control group was maintained at baseline level. CONCLUSIONS: It seems that intranasal use of the multi-herbal preparation can be used to improve chronic insomnia and to reduce the dose of conventional hypnotic medications in insomniac patients.

A double-blind, randomized, placebo-controlled trial of saffron stigma (Crocus sativus L.) in mothers suffering from mild-to-moderate postpartum depression.

INTRODUCTION: Numerous adverse effects of antidepressants as well as the attitudes of breastfeeding mothers, who prefer to consume herbal medicine rather than chemical drugs, encouraged us to assess the effects of saffron (Crocus sativus L.) on mothers suffering from mild-to-moderate postpartum depressive disorder. METHODS: A double-blind, randomized, and placebo-controlled trial was conducted on 60 new mothers who had a maximum score of 29 on the Beck Depression Inventory-Second Edition (BDI-II). They were randomly assigned to the saffron (15 mg/Bid) or placebo group. The primary outcome was a change in the BDI-II scores 8 weeks after treatment compared to the baseline. The response and remission rates were considered to be secondary outcome measures. RESULTS: Saffron had a more significant impact on the BDI-II scores than the placebo. The mean BDI-II scores decreased from 20.3 ±â€¯5.7 to 8.4 ±â€¯3.7 for the saffron group (p < .0001) and from 19.8 ±â€¯3.2 to 15.1 ±â€¯5.4 for the placebo group (p < .01). In the final assessment, 96% of the saffron group were in remission compared to 43% of the placebo group (p < .01). The complete response rates were 6% for the placebo group and 66% for the saffron group. CONCLUSION: When administered to treat minor PPD in breastfeeding mothers, saffron had a more significant impact on the BDI-II than the placebo.

Effect of Crocin on Antibody Titers to Heat-Shock Protein 27 in Subjects with Metabolic Syndrome.

BACKGROUND: Recent studies have shown that antibody titers to heat shock protein 27 (anti-Hsp27) and serum hs-CRP concentrations are elevated in patients with MetS, and may be associated with an increased risk of cardiovascular disease. Crocin is a natural carotenoid with cardio protective effects. OBJECTIVE: Because of the previous evidence for the beneficial effects of saffron in patients with MetS, this study investigated the effect of supplementation with crocin, the active ingredient of saffron, on serum anti-Hsp27 and hs-CRP in patients with MetS. DESIGN: Sixty subjects with metabolic syndrome were randomized to receive crocin (n=30, 15 mg twice a day) or placebo (n=30, twice a day) for a duration of eight weeks. At the end of study, serum anti-Hsp27 and hs-CRP concentrations were measured and compared between the groups. RESULTS: Serum anti-Hsp27 titers fell by 13% (p>0.05) in the crocin group but it rose in the placebo group by 22% (p>0.05). The magnitude of change in serum anti-Hsp27 titers was not significantly different between the study groups (p = 0.28). In the crocin group, serum anti-Hsp27 changes had a borderline negative correlation with glucose (r= -0.35, p=0.06) and a positive correlation with waist circumference (r=0.39, p=0.035). Serum hs-CRP levels were significantly reduced in both groups but these reductions were not significantly different between the study groups (p = 0.31). CONCLUSION: There was no significant effect of crocin on serum anti-Hsp27 titers in subjects with MetS, but this needs further confirmation in larger-scale trials.