scholarly journals The Effect of Intravenous Magnesium Sulphate as an Adjuvant in the Treatment of Acute Exacerbations of COPD in the Emergency Department: A Double-Blind Randomized Clinical Trial

2021 ◽  
Vol 31 (2) ◽  
Author(s):  
Fatemeh Jahanian ◽  
Iraj Goli Khatir ◽  
Hamed Amini Ahidashti ◽  
Sepideh Amirifard
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Magnesium Sulfate ◽  
Magnesium Sulphate ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Intravenous Magnesium ◽  
Acute Exacerbations ◽  
And Control

BACKGROUND፡ Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are serious complications that often require immediate intervention in an emergency department (ED). The aim of this study was to investigate the effect of intravenous magnesium sulphate as an adjuvant in the treatment of AECOPD in the ED.METHODS: In a double-blind, randomized clinical trial, a total of 60 patients with AECOPD presenting to the ED of Imam Khomeini Hospital in Sari, Iran, were included. The study was conducted between September 2016 and February 2018. Eligible patients were randomly allocated into two groups of intervention and control. Patients in the intervention and control groups received intravenous infusion of magnesium sulfate (2 gr) or normal saline over 30 minutes, respectively. For all patients, Borgdyspnea score, forced expiratory volume in one second (FEV1) result and clinical variables of interest were evaluated before the beginning of the intervention, and also 45 minutes and 6 hours after the commencement of intervention.RESULTS: Regardless of time of evaluation, pulse rate (PR), respiratory rate (RR) and Borg score in intervention group was lower than control group. Also, FEV1 and SPO2 were greater in intervention group compared to control group. However, these differences were not statistically significant (between-subject differences or group effect) (p<0.001). The trends of FEV1, SPO2, PR, RR and Borg score were similar between two groups of study (no interaction effect; P>0.05).CONCLUSION: According to the results of this study, it seems that using intravenous magnesium sulfate has no significant effect on SPO2, FEV1, RR, and PR of patients with AECOPD who presented to ED.

Effect of Nebulized Eucalyptus for Preventing Ventilator-Associated Pneumonia in Patients under Mechanical Ventilation: A Randomized Double Blind Clinical Trial

2018 ◽  
Author(s):  
HasanAli Karimpour ◽  
Behzad Hematpour ◽  
Saeed Mohammadi ◽  
Javad Aminisaman ◽  
Maryam Mirzaei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
Intervention Group ◽  
Control Group ◽  
Pulmonary Infections ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
And Control ◽  
And Staphylococcus Aureus

Abstract Background: Pneumonia caused by the ventilator is the most common acquired infection in the intensive care unit, which increases the morbidity and mortality of the patients. Eucalyptus plant has antiseptic properties. Therefore, the present study investigates the effect of eucalyptus incense on prevention of pneumonia in patients with endotracheal tube in the intensive care unit. Methods: This clinical trial study was performed on 100 patients under ventilation in two intervention and control groups in Imam Reza Hospital, Kermanshah, Iran in 2018. The patients in the intervention group, Eucalyptus solution 2% and in the control group received 10 cc distilled water as an inhaler three times a day. The results of the two groups were compared to the incidence of pulmonary infections based on CPIS criteria and compared with SPSS version 19 software. Results: The incidence of late pneumonia was significantly lower in the intervention group (P=0.02). The onset of pneumonia significantly later in the intervention group than the control group (P=0.01). The prevalence of Klebsiella, Candida albicans, and Staphylococcus aureus was significantly decreased in the intervention group (P=0.02) (P=0.04) (P=0.01). Conclusion: The results of this study showed that eucalyptus inhalation is effective in reducing the incidence of pulmonary infection in patients under ventilation. It is recommended that these products be used to prevent pulmonary infections in these patients.

Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
Author(s):  
Younes Najafian ◽  
Zahra M. Khorasani ◽  
Mona N. Najafi ◽  
Shokouh S. Hamedi ◽  
Marjan Mahjour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Aloe Vera ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Control Group ◽  
Plantago Major ◽  
Double Blind ◽  
Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

2021 ◽  
pp. 1357633X2110096
Author(s):  
Maria KEF Feijó ◽  
Karen Brasil Ruschel ◽  
Daniela Bernardes ◽  
Eduarda B Ferro ◽  
Luis E Rohde ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Heart Association ◽  
Functional Class ◽  
Emergency Department Visits ◽  
Control Group ◽  
Point Change ◽  
Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Application of Comfortable Nursing in the Preparation of Colostomy of Organs by Oral Magnesium Sulfate

1970 ◽  
Vol 1 (2) ◽  
Author(s):  
Zhou Shu
Keyword(s):  
Magnesium Sulfate ◽  
Intervention Group ◽  
Test Group ◽  
Nursing Intervention ◽  
Satisfaction Score ◽  
Control Group ◽  
Total Satisfaction ◽  
And Control ◽  
Experimental Group ◽  
Oral Magnesium

Objective: To explore the application of comfortable nursing in the preparation of colonoscopy in oral magnesium sulfate, and to provide scientific reference direction for nursing staff. Methods: 68 patients with colonoscopy were randomly divided into experimental group and control group (n = 34). In the control group, the routine nursing intervention was used, and the intervention group was treated with comfortable nursing intervention. Data analysis was performed using SPSS 20.0. Results: The total satisfaction score of the experimental group was (96.88 ± 1.26), the total satisfaction score of the control group was (80.65 ± 3.32), the test group (P < 0.05). The incidence of adverse reactions in the experimental group was significantly lower than that in the control group. The incidence of adverse reactions was 5.88% in the experimental group and 23.53% in the control group. Conclusion: The effect of comfortable nursing on the preparation of colonic gut in the oral magnesium sulfate method is relatively large.

Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

2018 ◽  
Vol 15 (3) ◽  
Author(s):  
Mansoor Keshavarz ◽  
Maryam Kashanian ◽  
Soodabeh Bioos ◽  
Yasaman Vazani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Control Groups ◽  
Persian Medicine ◽  
Traditional Persian Medicine ◽  
And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

scholarly journals EFEK SUPLEMENTASI MULTIVITAMIN MINERAL TERHADAP KADAR HEMOGLOBIN DAN HEMATOKRIT MAHASISWI TPB IPB

2013 ◽  
Vol 8 (1) ◽  
pp. 47
Author(s):  
Angga Hardiansyah ◽  
Rimbawan Rimbawan ◽  
Ikeu Ekayanti
Keyword(s):  
Intervention Group ◽  
Statistical Test ◽  
Female Students ◽  
Control Group ◽  
Blood Biomarkers ◽  
Control Groups ◽  
Double Blind ◽  
Mineral Supplementation ◽  
Quasi Experimental ◽  
And Control

The objective of this study was to analyze effect of multivitamin mineral supplementation to hemoglobin and hematocrit concentration of Bogor Agricultural University First Common Year female students. Design of this study was the quasi experimental, double blind, with number of subjects were 28 female students devided into two group. The intervention group consisted of 15 subjects, received supplement syrup 15 ml per day for eight weeks.The control group consisted of 13 subjects received placebo syrup. Data collected by interviewing subjects used questionnaire, physical examination, and blood biomarkers. The results of statistical test (paired sample t-test) showed that there were no significant increase in hemoglobin and hematocrit concentration respectively in both intervention and control groups (p&gt;0.05). However, on a subset of subjects anemia, the hemoglobin and hematocrit in the intervention group tended to increase larger than the control group.<br /><br />

scholarly journals The Effect of Vitamin B6 on Reducing the Number and the Size of Breast Cysts and the Amount of Recurrence after Aspiration in Women

2019 ◽  
pp. 1-7
Author(s):  
Setareh Soltany ◽  
Hamid Reza Hemmati ◽  
Jafar Alavy Toussy ◽  
Parisa Alavi Toosi
Keyword(s):  
Vitamin B6 ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
Double Blind ◽  
Breast Cyst ◽  
The Difference ◽  
Palpable Breast ◽  
Breast Lumps ◽  
And Control

Introduction: Palpable breast lumps are one of the most prevalent breast problems in women who visit a doctor. Most of these lumps are benign, and many of these benign lumps, have cystic nature. One of the suggested treatments for breast cyst is vitamin B6 intake. So, this study aimed to determine the effect of vitamin B6 on reducing the number and the size of breast cysts and reducing the amount of recurrence after aspiration. Materials and Methods: This study is a double-blind randomized clinical trial. Patients simply divided into two groups randomly, intervention group (receiving 150 mg vitamin B6 twice a day for two months) and control group (placebo). After data collection, the database produced, and information came in by SPSS-22 software. Descriptive results extracted in the form of tables and graphs. In all cases was used α=0.05. Results: At the end of the study, 65 patients (34 people in the intervention group, and 31 people in the control group) studied. At the end of the survey in the non-palpable cysts, was observed a significant decrease in the number and the size of breast cysts in each group receiving vitamin B6 or placebo. Still, the difference was not significant in comparing the two groups. 19 patients (2.29%) had palpable cysts that aspiration performed in all cases. After the study period, no recurrence of cysts observed in any of the intervention and control groups. Conclusion: The study showed that vitamin B6 had no effect on reducing the size and the number of non-palpable breast cysts and prevent recurrence of palpable cysts after aspiration.

scholarly journals The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Mahsa Miryan ◽  
Davood Soleimani ◽  
Leila Dehghani ◽  
Karim Sohrabi ◽  
Farzin Khorvash ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Clinical Symptoms ◽  
Intervention Group ◽  
Trial Registration ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Placebo Tablet ◽  
Full Protocol

Abstract Objectives This study aims to assess the effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19). Trial design This is a Double-Blind, Placebo-Controlled, Parallel Arm, Randomized Phase ΙΙ Clinical Trial. Participants Patients with the confirmed COVID-19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products. Patients will be recruited from the Al-Zahra hospital in Isfahan city, Isfahan, Iran. Intervention and comparator Participants (N=40) in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis extract) three times a day for a period of 2 weeks. Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Main outcomes The main outcomes are changes in the coronavirus disease’s clinical symptoms including duration and severity from baseline to the end of 2 weeks. Randomization Eligible patients will be randomly allocated in a 1:1 ratio to the intervention or control group. Randomization will be performed on the basis of permuted block sizes of 4 and will be stratified according to sex categories. Randomization sequences will be prepared by the trial’s pharmacist with the use of random-number tables. Blinding (masking) The trial-group assignment will be concealed from all participants, clinicians, and investigators throughout the trial. To ensure blinding, randomization sequences will be kept in identical, opaque, sealed, sequentially numbered envelopes. Only the trial's pharmacist has access to the randomization list. Also, the placebo tablet will be similar to the propolis tablet in terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labelling, and packaging. Numbers to be randomized (sample size) The calculated total sample size is 80 patients, with 40 patients in each group. Trial status The protocol is Version 1.0, October 10, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by March 21, 2021. Trial registration The name of the trial register: The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial. IRCT registration number: IRCT20200802048267N1. Date of trial registration: 20 October 2020, retrospectively registered. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals The Effect of Artichoke Leaf Extract on Alanine Aminotransferase and Aspartate Aminotransferase in the Patients with Nonalcoholic Steatohepatitis

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Vajiheh Rangboo ◽  
Mostafa Noroozi ◽  
Roza Zavoshy ◽  
Seyed Amirmansoor Rezadoost ◽  
Asghar Mohammadpoorasl
Keyword(s):  
Clinical Trial ◽  
Nonalcoholic Steatohepatitis ◽  
Liver Enzymes ◽  
Intervention Group ◽  
Control Group ◽  
Therapeutic Effects ◽  
Hypolipidemic Effect ◽  
Linear Regression Models ◽  
Double Blind ◽  
Cynara Scolymus

Background. Based on recent basic and clinical investigations, the extract of artichoke (Cynara scolymus) leaf has been revealed to be used for hepatoprotective and cholesterol reducing purposes. We aimed to assess the therapeutic effects of artichoke on biochemical and liver biomarkers in patients with nonalcoholic steatohepatitis (NASH).Methods. In a randomized double blind clinical trial, 60 consecutive patients suffering NASH were randomly assigned to receiveCynara scolymusextract (as 6 tablets per day consisting of 2700 mg extract of the herb) as the intervention group or placebo as the control group for two months.Results. Comparing changes in study markers following interventions showed improvement in liver enzymes. The levels of triglycerides and cholesterol were significantly reduced in the group treated withCynara scolymuswhen compared to placebo group. To compare the role ofCynara scolymususe with placebo in changes in study parameters, multivariate linear regression models were employed indicating higher improvement in liver enzymes and also lipid profile particularly triglycerides and total cholesterol following administration ofCynara scolymusin comparison with placebo use.Conclusion. This study sheds light on the potential hepatoprotective activity and hypolipidemic effect ofCynara scolymusin management of NASH. This clinical trial is registered in the IRCT, Iranian Registry of Clinical Trials, by numberIRCT2014070218321N1.

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