Efficacy of Persian medicine herbal formulations (capsules and decoction) compared to standard care in patients with COVID-19, a multicenter open-labeled, randomized, controlled clinical trial.

Persian medicine has recommended clinical experiences and proper herbal remedies for prevention and treatment of microbial infections and respiratory diseases. An open-label, randomized, controlled, multicenter trial was conducted at five hospitals in Tehran and Isfahan provinces of Iran on 358 hospitalized adult patients. A total of 174 patients received standard care and 184 received herbal remedies (polyherbal decoction every 8 hr and two herbal capsules every 12 hr) plus standard care for 7 days. The primary clinical endpoint was the duration of hospital stay, and secondary outcomes were clinical improvement of symptoms based on self-assessment questionnaire. Results demonstrated that these natural decoction and capsules treatment plus routine care significantly decreased duration of hospital dyspnea (3.291 day vs. 6.468 days), accelerated clinical improvement, and decreased symptoms such as dry cough, dyspnea, muscle pain, headache, fatigue, anorexia, chills, runny nose, sputum cough, and vertigo in the treatment group compared with standard-care group. Significant effects of these polyherbal formulations on improving the symptoms of COVID-19 could be incredibly promising for managing this pandemic with acceptable tolerability.

The effects of curcumin intake on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial.

This study was conducted to determine the effects of curcumin intake on wound healing and metabolic status in patients with diabetic foot ulcer (DFU). The current randomized, double-blind, placebo-controlled trial was conducted among 60 patients with grade 3 DFU. Participants were randomly allocated into two groups (30 participants each group), received either 80 mg nanocurcumin daily for 12 weeks or placebo. Primary endpoints in this study were serum insulin levels and insulin resistance. Curcumin intake significantly decreased fasting plasma glucose (p = .02), insulin (p = .01), insulin resistance (p = .02), and significantly increased insulin sensitivity (p = .008) compared with the placebo. Moreover, curcumin intake led to a significant reduction in total- (p < .001), LDL-cholesterol (p < .001), and a significant increase in total antioxidant capacity (TAC) (p < .001) and total glutathione (GSH) (p = .01) compared with the placebo. However, there was no significant improvement in wound healing parameters. Overall, our study demonstrated that nanocurcumin intake in patients with DFU resulted in a significant improvement of glycemic control, total- and LDL-cholesterol, TAC, and GSH but did not affect the indicators of ulcer size.

The effects of magnesium and vitamin E co-supplementation on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial.

This study was carried out to determine the effects of magnesium and vitamin E co-supplementation on wound healing and metabolic status in patients with diabetic foot ulcer (DFU). The current randomized, double-blind, placebo-controlled trial was conducted among 57 patients with grade 3 DFU. Participants were randomly divided into two groups to take either 250 mg magnesium oxide plus 400 IU vitamin E (n = 29) or placebo per day (n = 28) for 12 weeks. Compared with the placebo, taking magnesium plus vitamin E supplements reduced ulcer length (ß [difference in the mean of outcomes measures between treatment groups] -0.56 cm; 95% CI, -0.92, -0.20; p = 0.003), width (ß -0.35 cm; 95% CI, -0.64, -0.05; p = 0.02) and depth (ß -0.18 cm; 95% CI, -0.33, -0.02; p = 0.02). In addition, co-supplementation led to a significant reduction in fasting plasma glucose (ß -13.41 mg/dL; 95% CI, -20.96, -5.86; p = 0.001), insulin (ß -1.45 µIU/ml; 95% CI, -2.37, -0.52; p = 0.003), insulin resistance (ß -0.60; 95% CI, -0.99, -0.20; p = 0.003) and HbA1c (ß -0.32%; 95% CI, -0.48, -0.16; p < 0.003), and a significant elevation in insulin sensitivity (ß 0.007; 95% CI, 0.003, 0.01; p < 0.001) compared with the placebo. Additionally, compared with the placebo, taking magnesium plus vitamin E supplements decreased triglycerides (ß -10.08 mg/dL; 95% CI, -19.70, -0.46; p = 0.04), LDL-cholesterol (ß -5.88 mg/dL; 95% CI, -11.42, -0.34; p = 0.03), high sensitivity C-reactive protein (hs-CRP) (ß -3.42 mg/L; 95% CI, -4.44, -2.41; p < 0.001) and malondialdehyde (MDA) (ß -0.30 µmol/L; 95% CI, -0.45, -0.15; p < 0.001), and increased HDL-cholesterol (ß 2.62 mg/dL; 95% CI, 0.60, 4.63; p = 0.01) and total antioxidant capacity (TAC) levels (ß 53.61 mmol/L; 95% CI, 4.65, 102.57; p = 0.03). Overall, magnesium and vitamin E co-supplementation for 12 weeks to patients with DFU had beneficial effects on ulcer size, glycemic control, triglycerides, LDL- and HDL-cholesterol, hs-CRP, TAC, and MDA levels.

Magnesium Supplementation and the Effects on Wound Healing and Metabolic Status in Patients with Diabetic Foot Ulcer: a Randomized, Double-Blind, Placebo-Controlled Trial.

Hypomagnesemia is associated with the development of neuropathy and abnormal platelet activity, both of which are risk factors for diabetic foot ulcer (DFU). This study was carried out to evaluate the effects of magnesium administration on wound healing and metabolic status in subjects with DFU. This randomized, double-blind, placebo-controlled trial was performed among 70 subjects with grade 3 DFU. Subjects were randomly divided into two groups (35 subjects each group) to receive either 250 mg magnesium oxide supplements or placebo daily for 12 weeks. Pre- and post-intervention wound depth and appearance were scored in accordance with the "Wagner-Meggitt's" wound assessment tool. Fasting blood samples were taken at baseline and after the 12-week intervention to assess related markers. After the 12-week treatment, compared with the placebo, magnesium supplementation resulted in a significant increase in serum magnesium (+0.3 ± 0.3 vs. -0.1 ± 0.2 mg/dL, P < 0.001) and significant reductions in ulcer length (-1.8 ± 2.0 vs. -0.9 ± 1.1 cm, P = 0.01), width (-1.6 ± 2.0 vs. -0.8 ± 0.9 cm, P = 0.02), and depth (-0.8 ± 0.8 vs. -0.3 ± 0.5 cm, P = 0.003). In addition, significant reductions in fasting plasma glucose (-45.4 ± 82.6 vs. -10.6 ± 53.7 mg/dL, P = 0.04), serum insulin values (-2.4 ± 5.6 vs. +1.5 ± 9.6 µIU/mL, P = 0.04), and HbA1c (-0.7 ± 1.5 vs. -0.1 ± 0.4%, P = 0.03) and a significant rise in the quantitative insulin sensitivity check index (+0.01 ± 0.01 vs. -0.004 ± 0.02, P = 0.01) were seen following supplementation of magnesium compared with the placebo. Additionally, compared with the placebo, taking magnesium resulted in significant decrease in serum high-sensitivity C-reactive protein (hs-CRP) (-19.6 ± 32.5 vs. -4.8 ± 11.2 mg/L, P = 0.01) and significant increase in plasma total antioxidant capacity (TAC) concentrations (+6.4 ± 65.2 vs. -129.9 ± 208.3 mmol/L, P < 0.001). Overall, magnesium supplementation for 12 weeks among subjects with DFU had beneficial effects on parameters of ulcer size, glucose metabolism, serum hs-CRP, and plasma TAC levels. CLINICAL TRIAL REGISTRATION NUMBER: http://www.irct.ir : IRCT201612225623N96.

The effects of zinc supplementation on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial.

This study was performed to determine the effects of zinc supplementation on wound healing and metabolic status in patients with diabetic foot ulcer. The current randomized, double-blind, placebo-controlled trial was conducted among 60 patients (aged 40-85 years old) with grade 3 diabetic foot ulcer. Participants were randomly divided into two groups (30 participants in each group) to take either 220 mg zinc sulfate supplements containing 50 mg elemental zinc or placebo daily for 12 weeks. After the 12-week intervention, compared with the placebo, zinc supplementation was associated with significant reductions in ulcer length (-1.5 ± 0.7 vs. -0.9 ± 1.2 cm, p = 0.02) and width (-1.4 ± 0.8 vs. -0.8 ± 1.0 cm, p = 0.02). In addition, changes in fasting plasma glucose (-40.5 ± 71.0 vs. -3.9 ± 48.5 mg/dl, p = 0.02), serum insulin concentration (-8.0 ± 15.4 vs. +1.1 ± 10.3 µIU/ml, p = 0.009), homeostasis model of assessment-estimated insulin resistance (-3.9 ± 7.1 vs. +0.8 ± 5.9, p = 0.007), the quantitative insulin sensitivity check index (+0.01 ± 0.03 vs. -0.002 ± 0.02, p = 0.04) and HbA1c (-0.5 ± 0.8 vs. -0.1 ± 0.5%, p = 0.01) in the supplemented group were significantly different from the changes in these indicators in the placebo group. Additionally, significant increases in serum HDL-cholesterol (+4.1 ± 4.3 vs. +1.1 ± 5.1 mg/dl, p = 0.01), plasma total antioxidant capacity (+91.7 ± 213.9 vs. -111.9 ± 188.7 mmol/L, p < 0.01) and total glutathione (+68.1 ± 140.8 vs. -35.0 ± 136.1 µmol/L, p = 0.006), and significant decreases in high sensitivity C-reactive protein (-20.4 ± 24.6 vs. -6.8 ± 21.3 µg/ml, p = 0.02) and plasma malondialdehyde concentrations (-0.6 ± 0.9 vs. -0.2 ± 0.7 µmol/L, p = 0.03) were seen following supplementation with zinc compared with the placebo. Zinc supplementation for 12 weeks among diabetic foot ulcer patients had beneficial effects on parameters of ulcer size and metabolic profiles.

The effects of vitamin D supplementation on wound healing and metabolic status in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial.

OBJECTIVE: This study was conducted to evaluate the effects of vitamin D supplementation on wound healing and metabolic status in patients with diabetic foot ulcer (DFU). METHODS: This randomized, double-blind, placebo-controlled trial was performed among 60 patients with grade 3 DFU according to "Wagner-Meggitt's" criteria. Participants were randomly divided into two groups (each 30 participants) and received either 50,000IU vitamin D supplements every 2weeks for 12weeks (group A) or placebo (group B). Fasting blood samples were taken at study baseline and after 12-week intervention to determine related markers. RESULTS: After 12weeks of intervention, compared with the placebo, vitamin D supplementation resulted in a significant reduction in ulcer length (-2.1±1.1 vs. -1.1±1.1cm, P=0.001), width (-2.0±1.2 vs. -1.1±1.0cm, P=0.02) and depth (-1.0±0.5 vs. -0.5±0.5cm, P<0.001), and erythema rate (100% vs. 80%, P=0.01). In addition, in supplemented patients changes in serum insulin concentration (-3.4±9.2 vs. +2.8±9.3 µIU/mL, P=0.01), homeostasis model of assessment-estimated insulin resistance (-1.5±4.1 vs. +1.7±5.1, P=0.01), the quantitative insulin sensitivity check index (+0.006±0.02 vs. -0.006±0.02, P=0.03) and HbA1c (-0.6±0.6 vs. -0.1±0.5%, P=0.004) were significantly different from those of patients in the placebo group. Additionally, following supplementation with vitamin D, significant reductions in serum total- (-15.8±18.9 vs. +5.3±31.8mg/dL, P=0.003), LDL- (-17.2±19.8 vs. +2.2±28.6mg/dL, P=0.003), total-/HDL-cholesterol ratio (-1.1±0.8 vs. -0.2±1.1, P=0.001), high sensitivity C-reactive protein (hs-CRP) (-0.4±2.5 vs. +1.9±4.2µg/mL, P=0.01), erythrocyte sedimentation rate (ESR) (-34.7±32.4 vs. -18.0±26.6mm/h, P=0.03) and plasma malondialdehyde (MDA) concentrations (-0.7±0.9 vs. -0.2±0.5µmol/L, P=0.008) were seen compared with the placebo. CONCLUSIONS: Overall, vitamin D supplementation for 12weeks among patients with DFU had beneficial effects on glucose homeostasis, total-, LDL-, total-/HDL-cholesterol, ESR, hs-CRP and MDA levels. In addition, vitamin D may have played an indirect role in wound healing due to its effect on improved glycemic control.

Effects of zinc supplementation on serum zinc and leptin levels, BMI, and body composition in hemodialysis patients.

PROJECT: The aim of this study was to determine the effects of zinc supplementation on serum zinc and leptin levels as well as on anthropometric status and some biochemical parameters in hemodialysis (HD) patients. PROCEDURE: In this randomized, double-blind, and placebo-controlled trial, sixty HD patients were randomly divided into groups to receive a daily supplement of 100mg elemental Zn (supplemented group) or placebo (control group) for 60 days. Anthropometric measurements were taken using standard calibrated instruments. Serum zinc and leptin levels were determined by atomic absorption and ELISA method respectively before and after intervention. RESULTS: Zinc supplementation resulted in significant increase in the mean serum zinc level in the experimental group while changes observed in the placebo group were not significant. The mean serum leptin in women part of the experimental group was decreased significantly after supplementation. After adjusting for age, BMI, body fat (%), serum zinc and dietary Zn intake, a negative and significant association was observed between serum zinc and leptin levels in all subjects (ß=-0.33, P=0.03) as a result of Zn supplementation. CONCLUSIONS: More studies are needed to clarify the mechanisms by which serum leptin level is influenced as a result of zinc supplementation in HD patients.