جستجوی مقالات مرتبط با کلیدواژه « Trial » در نشریات گروه « پزشکی »

Hypertension (HTN) is a global public health problem with an increasing incidence worldwide. The imperative role of self-efficacy and dietary approach to stop hypertension (DASH) in controlling chronic disease has been reported.

We aim to investigate the efficiency of a mobile app for improving self-efficacy in adherence to the DASH diet in HTN patients.

The present randomized controlled trial was conducted on 88 patients with hypertension who were referred to public health care centers between November 2019 and March 2020. The subjects were randomly assigned to receive a video-based mobile app for DASH-related recommendations and usual care. The control group followed their habitual diets, and usual health care was given in a public health care center for twelve weeks. Self-efficacy, systolic blood pressure (SBP), diastolic blood pressure (DBP), body mass index (BMI), physical activity, and dietary intake were assessed at the trial’s baseline and end. The analysis of covariance (ANCOVA) was used to show the differences between groups and adjust for baseline and covariates.

At the baseline, there were no significant differences between the two groups regarding DBP, SBP, and most of the self-efficacy components. However, we observed significant statistical differences between the groups in the DBP SBP, and all five components of self-efficacy improved significantly at the end of the study. We did not reach a significant statistical difference between study groups in adherence to the DASH diet.

The present study showed that using a mobile app for educating DASH diet and improving self-efficacy leads to better control of HTN and improvement of self-efficacy.

 The internal septum of J.regia is traditionally used to control diabetes, and its effectiveness has been shown in animal studies. Accordingly, human clinical trials are needed to confirm its effectiveness on hemoglobin A1c (HbA1c), fasting blood sugar (FBS), blood insulin level, and insulin resistance as a complementary for better control of type 2 diabetes.

 This study was a randomized, double-blinded, controlled trial. The lyophilized powder of extract of the internal septum of J.regia was used to fill the capsules. Sixty type 2 diabetic patients were randomly divided into two groups. 500 mg capsules three times daily before meal was added to their routine drug regimen, and HbA1c, FBS, and blood insulin level were checked at the baseline and after three months.

 Sixty patients completed the study. The mean(±SD) age of patients was 49.1(10.2) and 50.9(12.7) years in the placebo and J.regia groups, respectively. We observed that J.regia internal septum increases the level of HbA1c by about 0.02 units, but this effect was not significant (MD=0.02,95%CI=-0.36 to 0.40, P=0.93). Regarding the impact of capsules on insulin level, it seems that J.regia-containing capsules can raise insulin level by one unit. However, it was not significant (MD=1.01,95%CI=-0.86 to 2.88, P=0.28). As for FBS, it can cause a decrease of four units, but this effect is also not significant (MD=-3.98,95%CI=-18.33 to 10.37, P=0.58).

 Based on our study, the internal septum of J.regia has no significant effect on HbA1c, FBS, and insulin resistance. Moreover, no specific adverse reaction was observed in any of the patients.

Among different treatments for periorbital hyperpigmentation (POH), both semi-invasive protocols of fractional CO2 laser and platelet-rich plasma (PRP) are favored among clinicians and rarely cause complications; however, the level of patients’ satisfaction seems to differ across these methods. This randomized clinical trial was conducted on 100 patients (98 women; 2 men) between 28 to 62 years of age who complained of POH and referred to the Dermatology Clinic of Rasool Akram Medical Complex located in Tehran in 2017. The patients were randomly assigned to two groups receiving fractional CO2 laser (group C) and adding PRP treatments plus laser therapy (group CP). The outcome of both treatment protocols was followed 3 and 6 months after the last treatment by standard photography. The time for swelling after treatment in the C and CP groups was 4.58 ± 0.61 days and 2.94 ± 0.68 days, respectively, which was significantly shorter in group CP (P < 0.001). The mean time for erythema disappearance was also shorter in group CP (5.20 ± 0.76 days vs. 3.40 ± 0.76 days, P < 0.001). Regarding the trend of the change in the ΔE parameter, it fell significantly in both groups within the follow-up period (P < 0.001); however, the mean ΔE was significantly higher in the CP group when compared with the control group (P < 0.001). There were no significant or resistant side effects in either treatment group. Although both therapies are effective and safe, the concurrent use of CO2 laser and PRP can more effectively reduce the severity of POH with a shorter duration of post-treatment swelling and erythema. Hence, this combination is a superior modality for the treatment of POH as compared to laser therapy alone.

Risk factors of noncommunicable diseases (NCD) are increasingly contributing to morbidity and mortality in Iran. Health care providers’ competencies and motivation are essential factors for the success and efficiency of primary health care.  This field trial aims to evaluate the impact of a results-based motivating system on population level of the NCD risk factors field trial (IRPONT) in Iran.

Population groups of 24 rural or urban catchment areas from 3 provinces were randomized to 1 of the 4 types of study groups. The groups were defined based on a set of 4 intervention packages. Extra 8 rural or urban catchment areas in a separate city were considered as independent nonintervention (control) group.  Population levels of major NCD risk factors in all 32 population groups were measured at the beginning of the trial, at the end of the first year, and will be measured in the second year through standardized population surveys. As the outcome measure, the difference in population levels of the risk factors will be compared among the study groups. Study group IV will be compared with combined control groups (study groups I, II, and III). Also, we will conduct subgroup analysis to determine the effects of interventions 2, 3, and 4.

Ethics: 

This trial has received ethical approval from National Institute for Medical Research Development in Iran (IR.NIMAD.REC.1396.084) in 2017.

Trial Registration Number: 

This trial has been registered on the Iranian Registry of Clinical Trials (identifier: IRCT20081205001488N2). Registered on 3 June 2018 and updated on 12 April 2020.

Shoulder joint dislocation and displacement is a common clinical condition. The present research aims to compare the clinical efficacy of ketamine versus dexmedetomidine during shoulder joint reduction.

In this randomized clinical double-blind trial method, patients aged 18 to 65 years with shoulder dislocation referred to the Emergency Hospital of Imam Khomeini Hospital in Ahvaz, Iran, were enrolled. Patients were separated into two groups, patients in group A received 1mg/kg nebu-lized ketamine and patients in group B received 1 μg/kg nebulized dexmedetomidine. Pain score was recorded at 5 different time points: Zero (before intervention), 10 minutes, 20 minutes, 30 minutes, and 60 minutes after intervention., The pain score was evaluated using the visual analog scale (VAS) test. A linear regression test was carried out to compare the slopes. Also, ANOVA repeated measures test variables differences between groups. Then Tukeychr('39')s multiple comparisons as post-hock were applied to compare the pains at different time points. Using IBM SPSS version 19.0 software, all analyzes were accomplished.

The pain score in both groups significantly decreased during different time points. The pain reduction slope in the group that received dexmedetomidine is meaningfully upper than that of ketamine (-0.08 vs. -0.06, p=0.012). The ketamine action onset time was 20 minutes after the in-tervention. In comparison, the effect of dexmedetomidine has an onset of 10 minutes after the in-tervention.

Overall, the results of current research demonstrated that although nebulized dexme-detomidine and nebulized ketamine produce a significant decrease in pain score, dexmedetomidine provides a faster effect. Therefore, nebulized dexmedetomidine seems to be used as an appropriate choice to induce sedation during shoulder joint reduction in emergency departments.

Due to the increasing spread of the Coronavirus 2019 (COVID-19), the competition for the most successful possible solution has become very popular among different countries. Therefore, addressing the issue of which is the next most likely candidate to enter the global market; It is a question that sooner or later every country must answer. This study was planned based on the latest published information on drugs that are currently undergoing the fourth clinical phase of the estuary, has tried to co ver the common concern, which means that recent reports indica te the importance of which of the existing or newly synthesized drugs in the control of this disease? The findings suggest that the introduced chemical structures are evidence of measurable succe ss on a laboratory scale, but there are no reliable reports of the high potency of these drugs to control or treat COVID-19 in long term. In conclusion, FDA approved most of these drugs permanently or under a specific condition. This means that scientists had to get along with trial and error these days to overcome the probable upcoming catastrophe.

Acne vulgaris is a disease of pilosebaceous unit with multifactorial pathogenesis and threats patients’ social functioning. There is a growing research to find faster, more effective, and easy to use treatments. The aim of this study is to evaluate the efficacy of benzoyl peroxide 5% (BP) with and without concomitant intense‑pulsed light (IPL) therapy in mild‑to‑moderate acne vulgaris.

In this controlled trial, 58 eligible patients with mild‑to‑moderate acne and Fitzpatrick skin phototype III and IV were randomly allocated to two groups. All patients were asked to use a thin layer of BP every night. The IPL therapy was administered at the end of first, 2nd, and 3rd months. Acne Global Severity Scale (AGSS), Acne Severity Index (ASI), and total lesion counting (TLC) along with patient satisfaction were recorded. Patients were also examined 1 month after the final therapeutic visit.

The IPL group showed greater reduction in AGSS (P < 0.001) and TLC (P = 0.005) than the control group. However, the difference in ASI was not significant (P = 0.12). Patients in IPL groups were more satisfied than control group (P < 0.001).

Adding IPL to BP can result better response to BP alone. In acne treatment, combination therapy such as IPL and other topical agents should be kept in mind.

Various beneficial effects of curcumin have been seen specially as anti-inflammator and antioxidant agent. However, until now no human studies have been done on curcumin’s role in control of appetite. So, the present study was done to determine the effect of nanocurcumin on appetite in obese Non-Alcoholic Fatty Liver Disease (NAFLD) patients.

This study was done in the central hospital of Oil Company, Tehran. According to the eligiblity criteria, 84 NAFLD patients with obesity were enrolled. The patients were devided randomly to 2 equal groups (nanocurcumin and placebo, 80 mg/day with meals, follow-up monthly for 3 months). In addition, lifestyle advises were presented. The general questionnaire, appetite sensations (using visual analogue scales [VAS]), , weight and height at the beginning and the end of the study were recorded

The mean age and body mass index (BMI) were 41.8(±5.6), 30.67(±2.14)and 42.5(±6.2)yrs and 30.75(±2.35)kg/m2 for nanocurcumin and placebo groups respectively. The baseline characteristics and dietary intakes were similar between patients, exception for energy, total fat, saturated fat, monounsaturated fatty acid, vitamins D, B1, B6, and folate (DFE). The appetite significantly reduced according to both unadjusted and adjusted analysis models.

This study was the first assess of nanocurcumin’s role in control of appetite among obese NAFLD patients. Overall results showed the nanocurcumin supplementation reduced appetite significantly. However, determining the potential role of curcumin in managing of NAFLD- and obesity-related conditions need further study.

There are different pathophysiological mechanisms for obsessive- compulsive disorder (OCD) as suggested by the serotonergic, dopaminergic, and glutamatergic hypotheses. The present study aimed at comparing the efficacy and safety of saffron (stigma of Crocus sativus) and fluvoxamine in the treatment of mild to moderate obsessive- compulsive disorder.
In this study, 50 males and females, aged 18 to 60 years, with mild to moderate OCD, participated. The patients were randomly assigned to receive either saffron (30 mg/day, 15 mg twice a day) or fluvoxamine (100 mg/day) for 10 weeks. Using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Adverse Event Checklist, we assessed the patients at baseline, and at the second, fourth, sixth, eighth, and tenth week. Finally, the data were analyzed using general linear repeated measures.
In this study, 46 patients completed the trial. General linear repeated measures demonstrated no significant effect for time-treatment interaction on the Y-BOCS total scores [F (2.42, 106.87) = 0.70, P = 0.52], obsession Y-BOCS subscale scores [F (2.47, 108.87) = 0.77, p = 0.49], and compulsion Y-BOCS subscale scores [F (2.18, 96.06) = 0.25, P = 0.79]. Frequency of adverse events was not significantly different between the 2 groups.
Our findings suggest that saffron is as effective as fluvoxamine in the treatment of patients with mild to moderate OCD.

Childhood obesity is becoming a global problem and its incidence is increasing. The role of dietary intervention with fruits containing vitamin C and flavonoid to control obesity consequences in childhood has not been yet defined. Lemon (Citrus aurantifolia) peels contain flavonoid, pectin and vitamin C. We aimed to compare the effects of lemon peels and placebo on cardiometabolic risk factors and markers of endothelial function among adolescents with overweight and obesity.
In this triple-masked, randomized controlled trial, 60 overweight/obese adolescents were enrolled in a 4-week trial. Eligible participants were randomly assigned into two groups of equal number receiving daily oral capsules containing lemon powder or placebo. Fasting blood sugar, lipid profile, ICAM-1 and VCAM-1, as well as systolic and diastolic blood pressure were compared between the two groups before and after administration of medication and placebo.
Of the total 60 enrolled patients, 30 and 29 patients in the lemon and control groups completed the study, respectively. The results of within-group analysis demonstrated a slight reduction in body mass index, LDL-C and systolic blood pressure in the lemon group, but no between group differences existed in the studied variables.
This study revealed that consumption of lemon peel extract has some beneficial effects for childhood obesity; however, no considerable effect was documented on anthropometric measures and biochemical factors. Future studies with longer follow up are highly recommended.