Evaluation of silver sulfadiazine 1%-cerium nitrate 2.2% cream efficacy and safety in moderate to severe burn patients: a single-blind randomized clinical trial.

BACKGROUND: Burn injury is a major global health crisis. Topical antimicrobials such as silver sulfadiazine (SSD) are commonly used for superficial burn wounds. SSD has a broad-spectrum antimicrobial activity and also anti-inflammatory property, but also suffers from some limitations. Therefore, some studies suggest to add cerium nitrate (CN) to SSD, as an immunomodulatory and tanning agent with antitoxic properties, but its effect on patients' mortality, length of hospital stay, and bacterial colonization is contraversial. OBJECTIVES: In this research, we evaluated the efficacy and safety of SSD 1%+CN 2.2% cream in patients with moderate to severe burn. MATERIAL AND METHODS: Twenty-two patients who fulfilled the inclusion criteria randomly were assigned to the intervention (n=7) or control (n=15) group and received SSD 1%+CN 2.2% or SSD cream 1% respectively, once daily until the complete re-epithelization or prepration of the burned skin for grafting. Intesity of pain, re-epithelialization time, required interventions, laboratory and clinical findings and final outcome were recorded. RESULTS: There was no significant difference in re-epithelialization time between the treatment and control groups (P>0.05). The same findings were reported about the required interventions and laboratory and clinical parameters. However, the final outcome and the pain score on third day were significantly better in the treatment group (P=0.017). On the other hand, all patients in the treatment group needed graft surgery. CONCLUSION: Use of SSD 1%+CN 2.2% cream did not significantly improve re-epithelization time or infection occurrence and patients' pain, but also increased graft surgery rate in comparison with SDD 1% cream in moderate to severe burns.

The effects of propolis supplementation on high-sensitivity C-reactive protein, testosterone hormone, and metabolic profile in women with polycystic ovary syndrome: A randomized, triple-blinded, placebo-controlled clinical trial.

One of the most prevalent ovulation disorders is polycystic ovarian syndrome (PCOS). According to the anti-inflammatory and beneficial effects of propolis, this triple-blind controlled trial was designed to evaluate the effect of propolis on metabolic factors, high-sensitivity C-reactive protein, and testosterone in women with PCOS. Recruited patients from the gynecologist clinic were randomized based on a stratified permuted four-block randomization procedure to supplement with propolis tablets, two tablets/day (500 mg propolis/day) (n = 30) or identical placebo tablets (n = 30) for 12 weeks in 2021 until 2022. Data were collected using a demographic questionnaire, blood samples, and a checklist to record the measured parameters. A total of 57 patients completed the trial. ANCOVA test showed that hip circumference (HC)) p = 0.03), fasting insulin (p = 0.007), homeostatic model assessment for insulin resistance (p = 0.004), testosterone (p = 0.004), and low-density lipoprotein (LDL)/high-density lipoprotein (HDL) (p = 0.02) were significantly decreased in the propolis versus the placebo group after adjustment for confounders. Although fasting blood glucose (p = 0.04) decreased significantly in the propolis group compared to the placebo, after adjusting for confounders, significance was lost (p = 0.09). Supplementation with propolis elicited positive effects on fasting insulin and insulin resistance, in addition to reducing the testosterone level, LDL/HDL, and HC, in PCOS women.

Dataset development of pre-formulation tests on fast disintegrating tablets (FDT): data aggregation.

OBJECTIVES: Tablet manufacturing development is costly, laborious, and time-consuming. Technologies related to artificial intelligence like ,predictive model ,can be used in the control process to facilitate and accelerate the tablet manufacturing process. predictive models have become popular recently. However, predictive models need a comprehensive dataset of related data in the field, due to the lack of a dataset of tablet formulations, the aim of this study is to aggregate and integrate fast disintegration tablet's formulation into a comprehensive dataset. DATA DESCRIPTION: The search strategy has been prepared between the years of 2010 to 2020, consisting of the keyword's 'formulation' ,'disintegrating' and 'Tablet', as well as their synonyms. By searching four databases, 1503 articles were retrieved, from these articles only 232 articles met all of the study's criteria. By reviewing 232 articles, 1982 formulations have been extracted, afterward pre-processing and cleaning data, contain steps of unifying the name and units, removing inappropriate formulations by an expert, and finally, data tidying was done on data. The developed dataset contains valuable information from various FDT's formulations, which can be used in pharmaceutical studies that are critical to the discovery and development of new drugs. this method can be applied to aggregate datasets from the other dosage forms.

Evaluation of Effects of Spray Drying Conditions on Physicochemical Properties of Pomegranate Juice Powder Enriched with Pomegranate Peel Phenolic Compounds: Modeling and Optimization by RSM.

In this study, the effects of pomegranate peel extract concentration (2.5-10%), drying temperature (160-190 °C), and feed flow rate (0.6-1 mL/s) on the properties of pomegranate juice powder enriched with pomegranate peel phenolic compounds and produced by spray drying were investigated. The moisture content, water activity (aw), solubility, water absorption capacity (WAC), hygroscopicity, dissolution time, total phenolic content (TPC), Carr index (CI), Hausner ratio (HR), and brightness (L*) of the samples were evaluated, and the optimal powder production conditions were obtained using response surface methodology (RSM). The results showed that the optimal conditions were found to be the phenolic extract concentration of 10%, the drying temperature of 189.9 °C, and the feed flow rate of 0.63 mL/s, considering the minimization of the moisture content, aw, hygroscopicity, dissolution time, CI, HR, and L*, as well as the maximization of solubility, WAC, and TPC. The effect of the phenolic extract concentration was very significant (p < 0.01) on the WAC, hygroscopicity, dissolution time, TPC, CI, HR, and L* of the powder. Moreover, the effect of the drying temperature was very significant (p < 0.01) on the aw, hygroscopicity, dissolution time, CI, and HR of the powder and significant (p < 0.05) on its moisture content. The effect of the feed flow rate was very significant (p < 0.01) on the solubility, hygroscopicity, and dissolution time of the powder and significant (p < 0.05) on its moisture content. Therefore, we found that the spray drying conditions, such as high temperature, did not negatively affect the content of phenolic compounds in pomegranate powder, and the physical properties of the resulting powder were acceptable. Thus, pomegranate powder enriched with phenolic compounds can be used as a food additive or as a dietary supplement for medicinal use.

Comparison of 5-ASA layered or matrix pellets coated with a combination of ethylcellulose and eudragits L and s in the treatment of ulcerative colitis in rats.

The aim of this study was to evaluate and optimize the combination of time and pH-dependent polymers as a single coating for the design of the colon-specific drug delivery system of 5-aminosalicylic acid (5-ASA) pellets. 5-ASA matrix pellets with a 70% drug load were prepared by the extrusion-spheronization method. The optimal coating formula which included Eudragit S (ES) + Eudragit L (EL) + Ethylcellulose (EC) was predicted for the targeted drug delivery to the colonic area by a 32 factorial design. The ratio of ES:EL:EC and coating level were considered as independent variables while the responses were the release of less than 10% of the drug within 2 h (Y1), the release of 60-70% within 10 h at pH 6.8 (Y2) and lag time of less than 1 h at pH 7.2 (Y3). Also, 5-ASA layered pellets were prepared by the powder layering of 5-ASA on nonpareils (0.4-0.6 mm) in a fluidized bed coater and then coated with the same optimum coating composition. The coated 5-ASA layered or matrix pellets were tested in a rat model of ulcerative colitis (UC) and compared with the commercial form of 5-ASA pellets (Pentasa®). The ratio of ES:EL:EC of 33:52:15 w/w at a coating level of 7% was discovered as the optimum coating for the delivery of 5-ASA matrix pellets to the colon. The coated 5-ASA pellets were spherical with uniform coating as shown by SEM and met all of our release criteria as predicted. In-vivo studies demonstrated that the optimum 5-ASA layered or matrix pellets had superior anti-inflammatory activities than Pentasa® in terms of colitis activity index (CAI), colon damage score (CDS), colon/body weight ratio and colon's tissue enzymes of glutathione (GSH) and malondialdehyde (MDA). The optimum coating formulation showed a high potential for colonic delivery of 5-ASA layered or matrix pellets and triggered drug release based on pH and time.

A review on curcumin colon-targeted oral drug delivery systems for the treatment of inflammatory bowel disease.

Synthetic drugs and monoclonal antibodies are the typical treatments to combat inflammatory bowel disease (IBD). However, side effects are present when these treatments are used, and their continued application could be restricted by the high relapse rate of the disease. One potential alternative to these treatments is the use of plant-derived products. The use curcumin is one such treatment option that has seen an increase in usage in treating IBD. Curcumin is derived from a rhizome of turmeric (Curcuma longa), and the results of studies on the use of curcumin to treat IBD are promising. These studies suggest that curcumin interacts with cellular targets such as NF-κB, JAKs/STATs, MAPKs, TNF-α, IL-6, PPAR, and TRPV1 and may reduce the progression of IBD. Potentially, curcumin can be used as a therapeutic agent for patients with IBD when it reduces the incidence of clinical relapse. This review discusses the strategies utilized in designing and developing an oral colonic delivery dosage form of curcumin.

Effect of vitamin D vaginal suppository on sexual functioning among postmenopausal women: A three-arm randomized controlled clinical trial.

OBJECTIVE: Vaginal atrophy, the second most common complication of menopause, can lead to sexual dysfunction. This study evaluated the effect of a vitamin D vaginal suppository on sexual functioning in postmenopausal women. METHODS: This three-arm randomized controlled trial was conducted between August 2019 and August 2020. The sample comprised 105 postmenopausal women who were referred to comprehensive health service centers to receive postmenopausal care. The inclusion criteria were as follows: (i) being menopausal for at least 1 year, (ii) being married, (iii) being sexually active, and (iv) having sexual desire. Participants were randomly assigned to three groups for 8 weeks of treatment: intervention (vaginal suppository containing 1,000 units of vitamin D3), placebo (vaginal suppository placebo), or control (no treatment). The main outcome measure was sexual functioning, which was assessed using the Female Sexual Function Scale (FSFI) 4 times during the study (i.e., 1 month before the intervention, immediately after the intervention, 1 month after the intervention, and 2 months after the intervention). RESULTS: Immediately and 1 month after the trial, the intervention group had the highest FSFI score, followed by the placebo group, both of which were significantly higher than those of the control group (P<0.05). At the 2-month follow-up, the intervention and placebo groups had similar FSFI scores (P=0.08), both of which were significantly higher than those in the control group (P=0.001 and P=0.03, respectively). CONCLUSION: Vitamin D vaginal suppositories were more effective at improving sexual functioning among postmenopausal women in the short-term and appeared to prevent aging-related sexual functioning decline in the long term.

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.

Preparation of stable enteric folic acid-loaded microfiber using the electrospinning method.

Objectives: Folic acid is an essential vitamin, labile to hydrolysis in the acidic environment of the stomach with low water solubility and bioavailability. In order to solve these problems, enteric oral folic acid-loaded microfibers with a pH-sensitive polymer by electrospinning method were prepared. Materials and Methods: Electrospinning was performed at different folic acid ratios and voltages. Fibers were evaluated in terms of mechanical strength, acidic resistance, and drug release. Additionally, DSC (Differential Scanning Calorimetry), FTIR (Fourier-transform infrared spectroscopy), and XRD (X-ray diffraction) analyses were performed on the optimal formulation. Results: Drug ratio and voltage had a considerable effect on fibers' entrapment efficiency, acid resistance, and mechanical strength. Based on the obtained results, the optimum formulation containing 1.25% of the drug/polymer was prepared at 18 kV. The entrapment efficiency of the optimal sample was above 90% with an acid resistance of higher than 70%. The tensile test confirmed the high mechanical properties of the optimum microfiber. DSC and XRD tests indicated that folic acid was converted to an amorphous form in the fiber structure and the FTIR test confirmed the formation of a chemical bond between the drug and the polymer. The release of the drug from the optimal fiber was about 90% in 60 min. Conclusion: In conclusion, the optimal formulation of folic acid with proper mechanical properties can be used as a candidate dosage form for further bioavailability investigations.

Effects of propolis supplementation on irritable bowel syndrome with constipation (IBS-C) and mixed (IBS-M) stool pattern: A randomized, double-blind clinical trial.

Background: Recent evidence indicates that propolis can modulate gastrointestinal (GI) function. This trial aims to assess the efficacy of propolis supplementation on the severity of irritable bowel syndrome (IBS) symptoms. Methods: This clinical trial was conducted on 56 subjects with IBS diagnosed by Rome IV criteria. Eligible subjects were randomly assigned to receive either 900 mg/day of propolis or matching placebo tablets for 6 weeks. The IBS symptom severity scale (IBS-SSS) was used to evaluate IBS severity in five clinically applicable items. Results: After adjusting anxiety scores, a significant reduction was observed in the overall score of IBS symptoms (-98.27 ± 105.44), the severity of abdominal pain (-24.75 ± 28.66), and the frequency of abdominal pain (-2.24 ± 3.51) with propolis treatment as compared to placebo (p-value < .05). Patients in the propolis group were 6.22 times more likely to experience improvement in IBS symptoms than those in the placebo group (95% CI: 1.14-33.9; p-value: .035). There was no significant change in anthropometric measurements and dietary intakes in both groups (p-value > .05). Conclusions: Our results showed that propolis supplementation might have a beneficial effect on constipation subtype of IBS (IBS-C) and mixed subtype of IBS (IBS-M) severity by reducing the severity and frequency of abdominal pain in patients with irritable bowel syndrome (IBS).

Evaluation of the efficacy of Thymus kotschyanus extract as an additive treatment in patients with ulcerative colitis: a randomized double-blind placebo-controlled trial.

BACKGROUND: Ulcerative colitis (UC) is one of the chronic diseases which is increasing in prevalence and patients suffer from illness flare-ups. UC standard regimen treatment has various side effects besides the efficacy, so there is an interest in administering complementary medicine to reduce adverse effects and increase the efficacy, as well. The aim of this study was to evaluate the efficacy and anti-inflammatory effect of Thymus kotschyanus as an additive treatment in a randomized double-blind placebo-controlled trial of UC patients. METHODS: Thirty UC out-patients with mesalazine regimen treatment that fulfilled the inclusion criteria were participated in a 12 week trial and were randomly chosen for the treatment and control group. Fifteen patients were administered a placebo as a control and 15 patients were received Thymus kotschyanus extract by a dose of 0.5 g in a day in the treatment group. Laboratory tests were performed at baseline and week 12. The primary outcome was a reduction in fecal calprotectin as the main intestine inflammatory marker. Likewise, reduction in SCCAI, SIDBQ, and SEO indices were considered as secondary aims. RESULTS: Fecal calprotectin was decreased by 54.74% in the treatment group, as compared with the placebo group at week 12 (p = 0.02). A significant reduction in SCCAI was also shown between the two study groups (p = 0.01). Thymus kotschyanus extract was safe and no severe side effects were reported. CONCLUSION: Administration of Thymus kotschyanus revealed improvement in UC symptoms by the intestinal anti-inflammation effect of the plant and could be suggested as a potential additive treatment in UC patients. The study protocol has been registered under the identification code: IRCT20200406046965N2.

Comparison of lipid liquid crystal formulation and Vivitrol® for sustained release of Naltrexone: In vitro evaluation and pharmacokinetics in rats.

Camurus' FluidCrystal® injection depot is a lipid liquid crystal (LLC) phase formation-based method, comprising of glycerol dioleate (GDO) and soy phosphatidylcholine (SPC), together with minute quantities of N-methyl-2-pyrrolidone solvent (NMP). The present study aimed to develop a method for LLC using sorbitan monooleate (LLC-SMO) instead of GDO to prepare a one-month sustained-release formulation of naltrexone (NTX) that is applied for the treatment of autism and treating alcohol dependence. The optical characteristics of the LLC were assessed by polarizing light microscopy (PLM) to reveal the presence of lamellar, hexagonal, and cubic mesophases. Furthermore, in vitro release of NTX and NMP, degradation, pharmacokinetics, and histopathology of LLC-GDO and LLC-SMO in rats were evaluated and compared to those of Vivitrol®. The PLM images revealed that the structure of LLC-SMO is hexagonal, similar to LLC-GDO. The in vitro release of NTX and its pharmacokinetic results in rats indicted that the LLC-SMO system is more uniform than LLC-GDO and Vivitrol® during 35 days. Histopathological results of LLC-GDO and LLC-SMO confirmed the biocompatibility of our LLC delivery systems. Taken together these data demonstrate that the LLC-SMO-based method, was efficient enough to sustain the release of NTX in vitro and in vivo, confirming the biocompatible nature of this delivery system.

Development and Evaluation of Vaginal Suppository Containing Althaea officinalis L. Polysaccharide Extract

Abstract Intrauterine adhesions cause several gynecological problems. Althaea officinalis L. roots known as marshmallows contain polysaccharides (M.P.) which possess anti-inflammatory and anti-ulcerogenic activities also can form a bio-adhesive layer on damaged epithelial membranes prompting healing processes. Vaginal formulations of herbal origin are commonly applied to relieve cervico-uterine inflammation. Herein, we aim to develop and evaluate vaginal suppositories containing polysaccharides isolated from the A. officinalis root. Six formulations (four P.E.G.-based and two lipid-based suppositories containing 25% and 50% M.P.) met standard requirements, which were then subjected to qualitative and quantitative evaluation. All suppositories exhibited acceptable weights, hardness, content uniformity, melting point, and disintegration time, which fall within the acceptable recommended limits. Higher concentrations of M.P. in PEG-bases moderately increased the hardness (p<0.05). PEG-formulations showed content uniformity>90% of the average content while it was 75-83% for suppocire formulations. All formulations disintegrated in<30minutes. In-vitro release test revealed that M.P. release from 25%-MP formulations was higher than that of 50%-M.P. suppositories. Overall, results revealed the feasibility of preparing P.E.G.-or lipid-based suppositories containing M.P., which met the B.P. quality requirement

A randomized clinical trial on therapeutic effects of 0.25 mg oral minoxidil tablets on treatment of female pattern hair loss.

Topical minoxidil solution is recommended treatment for female pattern hair loss. However, some complications, such as skin allergies, have prevented some patients from completely receiving this treatment. This study intends to evaluate the therapeutic and side effects of oral minoxidil 0.25 mg tablets treatment on FPHL and compare it with conventional treatment of 2% topical minoxidil. This study is a triple-blind randomized clinical trial in which 72 women with FPHL were treated as two separate groups. Group 1 was treated with oral minoxidil 0.25 mg tablets and topical placebo solution, while topical minoxidil solutions and oral placebo tablets were used to treat group 2 patients. In the oral minoxidil group, the average hair diameter and hair density after the 9-month treatment reached from 0.044 mm and 102 per cm2 to 0.048 mm and 115 per cm2 , respectively. In the topical minoxidil group, the average hair diameter and hair density from initial values of 0.044 mm and 107 per cm2 increased to 0.047 mm and 113 per cm2 . In both groups, the changes of hair diameter and hair density were significant compared to initial values (p < 0.001), while the trend of changes was not statically different between the two groups (p = 0.077, p = 0.674 for hair diameter and hair density, respectively) and side effects were trivial. In conclusion, oral minoxidil is an effective and new treatment for FPHL, even with a minimal dose, which can be used as an alternative treatment, especially for patients with poor compliance against topical minoxidil.

The Effect of Thermal-Treating on Drug Release from Sustained Release Alginate-Eudragit RS Matrices.

Purpose: The main objective of the present study was to develop the colonic delivery system for 5-aminosalicylic acid (5-ASA) as an anti-inflammatory drug. Methods: Matrix pellets containing various proportions of alginate, calcium and Eudragit® RS were prepared by extrusion-spheronization technique. Thermal treatment was used to investigate the effect of the curing process on the surface morphology, mechanical and physicochemical properties and in vitro drug release profile of pellets. Based on the obtained results optimal formulations were selected to coating by the Eudragit® RS and subjected to a subsequent continuous dissolution test. Results: Image analysis and also scanning electron microscopy results proved acceptable morphology of the pellets. The fourier transform infrared spectroscopy and differential scanning calorimetry studies ruled out any interactions between the formulation's components. Curing process did not alter the mechanical properties of pellets. The release rate of the drug from matrices was prolonged due to the decreased porosity of cured pellets. Furthermore, selected cured pellets which coated with Eudragit® RS, prevented undesired premature drug release. Conclusion: Formulation containing 17.5% calcium, 17.5% alginate, and a coating level of 10% demonstrated enhanced drug release so that provided resistance to acidic conditions, allowing complete drug release in alkaline pH, mimicking colonic environment. The slow and consistent drug release from this formulation could be used for treatment of a broader range of Inflammatory bowel disease (IBD) patients especially in whom colonic pH levels have been measured at lower than pH 7.0.

Evaluation of the Anti-constipation Effects of Abdominal Application of Olive Oil Ointment in Children 1-4 Years Old: A Pilot Placebo-Controlled, Double-Blind, Randomized Clinical Trial.

OBJECTIVE: With a prevalence of 0.7 to 29.6%, functional constipation (FC) is a common pediatric complaint worldwide. Current therapeutic strategies for FC mainly include prevention and treatment of fecal impaction, by administration of oral laxatives or rectal medications. However, these agents have been reported to have limited efficacy and a number of serious side effects. In traditional Persian medicine, local application of olive oil was used to relieve childhood constipation. In this pilot placebo-controlled, double-blind, randomized clinical trial, the laxative effects of the external use of olive oil ointment in 1- to 4-year-old children with functional constipation were investigated. METHODS AND MATERIALS: Forty patients with FC were randomly assigned in olive oil ointment or placebo groups, receiving either an ointment containing 85% olive oil or a comparable placebo or an ointment containing 85% liquid paraffin adjusted to have color and odor similar to those of intervention ointment, twice a day for 4 days. Rome III criteria for functional gastrointestinal disorders (FGIDs) were used to identify eligible patients from three hospitals. The primary outcome measure was treatment success, defined as ≥1 spontaneous stools per day, without episodes of fecal impaction at endpoint (day 4). The secondary outcome measure was the frequency of fecal incontinence, abdominal discomfort or flatulence, painful defecation, and dermal irritations (adverse effect). RESULTS: Improvements in stool frequency started from day 1 and continued up to day 4 (end of the study) and were significantly greater in patients receiving olive oil ointment in comparison with placebo group (p < 0.05). No adverse effect (including fecal incontinence, painful defecation, gripe and skin reaction, etc.) was reported in intervention and placebo groups during the study. CONCLUSION: Olive oil ointment used in this study can be presented as a safe, well-tolerated, and effective herbal preparation in children with functional constipation.

Protective effects of propolis on hepatic steatosis and fibrosis among patients with nonalcoholic fatty liver disease (NAFLD) evaluated by real-time two-dimensional shear wave elastography: A randomized clinical trial.

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease, while no drugs have been approved for its treatment. The pieces of evidence indicate that propolis as a novel anti-inflammatory agent might be a promising candidate to treat NAFLD. We aimed to evaluate the efficacy of propolis on hepatic steatosis and fibrosis in patients with NAFLD. This randomized clinical trial was conducted on 54 patients with NAFLD. Patients were randomly assigned to receive propolis tablets at a dose of 250 mg twice daily for 4 months or placebo. The improvement in hepatic steatosis and fibrosis was evaluated using two-dimensional shear wave elastography. Improvement in the hepatic steatosis was significantly higher in the propolis group than the placebo group, even after adjustment for baseline value and changes in weight, energy intake, and physical activity (odds ratio [OR]: 5.67; 95% confidence intervals [CI]: 1.41-22.8; p = .014). A significant reduction was observed on the liver stiffness in the propolis group (-0.65 ± 0.56 kPa; p = .001), whereas it increased in the placebo group (0.27 ± 0.59 kPa; p = .037). Also, the intake of propolis significantly decreased high-sensitivity C-reactive protein (hs-CRP) levels compared with the placebo group (-0.371; 95%CI: -0.582 to -0.16 mg/L; p = .01). Changes in serum levels of fasting blood sugar, alanine aminotransferase, aspartate aminotransferase, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, cholesterol, and triglyceride did not differ significantly between the two groups (p > .05). There was no significant improvement in insulin resistance in both groups (p > .05). Propolis seems to have protective effects on hepatic steatosis and fibrosis and to reduce the serum levels of hs-CRP in patients with NAFLD.

Topical green tea formulation with anti-hemorrhagic and antibacterial effects.

OBJECTIVES: Potentially preventable death from uncontrolled hemorrhage clearly indicates the importance of simple, fast and efficient ways to achieving hemostasis. The aim of this study was to develop a topical formulation of green tea extract for reducing bleeding that can be helpful in hemorrhage control. MATERIALS AND METHODS: Hydroalcoholic extract of green tea was isolated from Camellia sinensis and formulated in polyvinyl alcohol (PVA) to achieve two concentrations of 2% and 4% v/v. Folin-Ciocalteau assay was used to determine the total amount of tannins in extract. Rheological behavior of solutions was investigated by measuring viscosity at shear rates of 0-200 sec-1. Quantitative and qualitative microbial limit tests and minimum inhibitory concentration (MIC) assay were done. The effect of formulations on bleeding time was evaluated in an animal model. RESULTS: The total amount of tannin in green tea extract was 3.8% w/w and addition of green tea significantly increased the viscosity of PVA. The results of MIC assay showed that PVA could not inhibit the growth of bacteria, while, 716 µg/ml of green tea and 2860 µg/ml of green tea/PVA 4% inhibited the growth of Staphylococcus aureus and Pseudomonas aeruginosa. In an animal study both 2% and 4% formulations were able to stop hemorrhage approximately at an equal time compared with tranexamic acid (TXA) 50 mg/ml as a control and the lowest bleeding time was 6.4±0.51 sec for green tea/PVA 4%. CONCLUSION: Based on our results, the topical formulation of green tea extract in PVA has a great potential for anti-hemorrhage applications.

Does propolis affect the quality of life and complications in subjects with irritable bowel syndrome (diagnosed with Rome IV criteria)? A study protocol of the randomized, double-blinded, placebo-controlled clinical trial.

BACKGROUND: Irritable bowel syndrome (IBS) is one of the most frequent and recurrent gastrointestinal diseases. However, up to now, no pharmacological agent has been approved to treat IBS. Emerging evidence showed that inflammation has a vital role in enhancing nervous system sensitivity and perception of abdominal pain in subjects with IBS. Propolis is an herbal substance with a broad spectrum of antioxidants, anti-inflammatory, and prebiotic properties, which might exert beneficial effects to reduce the severity of IBS. The current clinical trial aims to evaluate the efficacy of propolis supplementation on IBS. METHODS: This single-center, randomized, double-blind, placebo-controlled clinical trial will be performed to evaluate the effect of propolis supplementation in adult patients with IBS diagnosed with Rome IV criteria. Fifty-two eligible patients will randomly be allocated to receive a propolis tablet (450 mg, containing 100 mg polyphenol compounds) or identical placebo, twice daily for 6 weeks. The primary outcome of the trial is an improvement in IBS severity from baseline to the sixth week of intervention. The secondary outcomes include the change in weight, waist circumference, and IBS quality of life. We will use the paired sample t test or Mann-Whitney U test for the within-group comparison and independent sample t test or Wilcoxon rank-sum and chi-square test or Fisher's exact test for the between-group comparison. Besides, a multivariable-adjusted mean effect will be computed using the ANCOVA test. DISCUSSION: We hypothesize that propolis supplementation would be useful for treating IBS through its antioxidants, anti-inflammatory, and prebiotic properties. This trial will show the results of propolis supplementation, whether positive or negative, on IBS. If the current trial confirms our hypothesis, propolis supplementation can be a new choice in adjunctive therapy of IBS. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20190708044154N1. Registered on 26 December 2019. Updated on 13 February 2020. https://en.irct.ir/trial/40983 SPONSOR: Tabriz University of Medical Sciences, Tabriz, Iran.