scholarly journals Effects of fenugreek seed powder on stress-induced hyperglycemia and clinical outcomes in critically ill patients: A randomized clinical trial

2018 ◽  
Vol 5 (9) ◽  
pp. 2664-2670
Author(s):  
Akram Kooshki ◽  
Zaher Khazaei ◽  
Mojtaba Rad ◽  
Azam Zarghi ◽  
Akram Chanbari Mogaddam
Keyword(s):  
Clinical Trial ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Intervention Group ◽  
Routine Care ◽  
Wilcoxon Test ◽  
Apache Ii Score ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Fenugreek Seed

Introduction: Stress-induced hyperglycemia (SIH) is commonly observed in critically ill patients and associated with poor clinical outcome for patients. Fenugreek seed powder has long been known as an anti-diabetic drug since its pharmaceutical properties were demonstrated. Materials: The study herein was a parallel, randomized controlled clinical trial consisting of 60 adult patients randomly divided into 2 groups (n=30 per group). The study was conducted in Sabzevar, Iran in April 2015. The intervention group received 3 g of fenugreek seed powder by gavage, twice a day, in addition to routine care. The control group received only routine care. In the beginning, a daily evaluation of fasting and postprandial blood sugar was conducted for 10 days. Secondary components (prevalence of pneumonia; length of intensive care unit (ICU) stay, length of hospital stay, ventilator days, APACHE II score, and mortality rate) were measured until the time of hospital discharge or death. Data were analyzed via SPSS v.20 using Student's t-test (paired and unpaired), chi-square test, repeated measure ANOVA, and Wilcoxon test. Results: In during 10 days of treatment, there was a significant fall in mean glucose levels in 2 groups. However, this improve was more significant in Intervention group in compared to control group (p<0.001). Conclusion: The present study suggests that daily diet with fenugreek seeds can be used as an add-on therapy with other medications in the management of SIH in critically ill patients.

scholarly journals The Effect of Support Surfaces on the Incidence of Pressure Injuries in Critically Ill Patients: A Randomized Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Wesley Henrique Bueno de Camargo ◽  
Rita de Cassia Pereira ◽  
Marcos T. Tanita ◽  
Lidiane Heko ◽  
Isadora C Grion ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Intervention Group ◽  
Control Group ◽  
Support Surface ◽  
Intention To Treat ◽  
Support Surfaces ◽  
Effect Of Support

Purpose. To analyze whether a viscoelastic mattress support surface can reduce the incidence of stage 2 pressure injuries compared to a standard hospital mattress with pyramidal overlay in critically ill patients. Method. A randomized clinical trial with intention-to-treat analysis was carried out recruiting patients with Braden scale ≤14 on intensive care unit admission from April 2016 to April 2017. Patients were allocated into two groups: intervention group (viscoelastic mattress) and control group (standard mattress with pyramidal overlay). The level of significance adopted was 5%. Results. A total of 62 patients were included in the study. There was a predominance of males (53%) and the mean age was 67.9 (SD 18.8) years. There were no differences in clinical or severity characteristics between the patients in the control group and the intervention group. Pressure injuries occurred in 35 patients, with a median time of 7 days (ITQ 4–10) from admission. The frequency of pressure injuries was higher in the control group (80.6%) compared to the intervention group (32.2%; p<0.001). Conclusions. Viscoelastic support surfaces reduced the incidence of pressure injuries in moderate or higher risk critically ill patients when compared to pyramidal support surfaces.

scholarly journals The Effect of Vitamin C on Pathological Parameters and Survival Duration of Critically Ill Coronavirus Disease 2019 Patients: A Randomized Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Nazanin Majidi ◽  
Faezeh Rabbani ◽  
Somayeh Gholami ◽  
Maryam Gholamalizadeh ◽  
Fatemeh BourBour ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin C ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Intervention Group ◽  
Survival Duration ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Arterial Blood ◽  
Vitamin C Supplementation

IntroductionVitamin C has been reported to have beneficial effects on patients with coronavirus disease 2019 (COVID-19). This study aimed to investigate the effect of vitamin C supplementation on pathological parameters and survival duration of critically ill patients with COVID-19.MethodsThis clinical trial was conducted on 120 hospitalized critically ill patients infected with COVID-19. The intervention group (n = 31) received one capsule of 500 mg of vitamin C daily for 14 days. The control group (n = 69) received the same nutrition except for vitamin C supplements. Measurement of pathological and biochemical parameters was performed at baseline and after 2 weeks of the intervention.ResultsFollowing 2 weeks of vitamin C supplementation, the level of serum K was significantly lower in the patients compared with the control group (3.93 vs. 4.21 mEq/L, p &lt; 0.01). Vitamin C supplementation resulted in a higher mean survival duration compared with that of the control group (8 vs. 4 days, p &lt; 0.01). There was a linear association between the number of days of vitamin C intake and survival duration (B = 1.66, p &lt; 0.001). The vitamin C supplementation had no effect on blood glucose, mean arterial pressure, arterial blood gas (ABG) parameters, Glasgow Coma Scale (GCS), kidney function, cell blood count (CBC), hemoglobin (Hb), platelet (Plt), partial thromboplastin time (PTT), albumin, hematocrit (Hct), and other serum electrolytes including sodium (Na), calcium, and phosphorus (P).ConclusionThe present study demonstrated the potential of vitamin C supplementation in enhancing the survival duration of critically ill patients with COVID-19.Clinical Trial Registrationhttps://www.irct.ir/trial/55074, identifier IRCT20151226025699N5

scholarly journals The effect of group therapy using the cognitive approach on the empowerment of mothers raising a child with autistic disorder:A randomized-controlled clinical trial

2019 ◽  
Vol 7 (1) ◽  
pp. 23-31
Author(s):  
Hossein Ebrahimi ◽  
Maryam Vahidi ◽  
Ayyoub Malek ◽  
Jalil Babapour Kheiroddin ◽  
Nafiseh Abdorrahmani
Keyword(s):  
Clinical Trial ◽  
Group Therapy ◽  
Autistic Disorder ◽  
Intervention Group ◽  
Routine Care ◽  
T Test ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Cognitive Approach

Introduction: The diagnosis of autistic disorder may impose stress on the child’s parents especially the mother of the baby. Raising a child with autistic disorder reduces parents' quality of life. This study examined the effect of group therapy using a cognitive approach on empowerment in the mothers of children with autistic disorder. Methods: This randomized clinical trial was carried out with 80 mothers of children with the autistic disorder. They referred to Autism Society Rehabilitation Center in Tabriz, Iran. The mothers were randomly allocated into intervention and control groups. The intervention group was divided into 4 groups of 10, and each group participated in 10 sessions of group therapy using the cognitive approach. The control group received the routine care. Data were collected using the Family Empowerment Scale (FES) before the intervention and two months after the intervention. Data were analysed using descriptive and inferential statistics [t-test, χ2, and analysis of covariance (ANCOVA)] via the SPSS software. Results: The independent t-test showed that the means of total empowerment and its dimensions had no statistically significant differences before the intervention. However, after the intervention, such differences between the groups were statistically significant (P < 0.001); so that the mothers in the intervention group achieved higher scores on empowerment and its dimensions compared with the control group. Conclusion: Group therapy using the cognitive approach can be used by healthcare professionals in rehabilitation centers for empowering the mothers of children with autistic disorder.

scholarly journals Knowledge and attitude of candidates to gastroplasty about perioperative: randomized clinical trial

2020 ◽  
Vol 73 (6) ◽  
Author(s):  
Lívia Moreira Barros ◽  
Francisca Antônia do Vale Gomes ◽  
Flávio Neves Carneiro ◽  
Nelson Miguel Galindo Neto ◽  
Natasha Marques Frota ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Educational Intervention ◽  
Intervention Group ◽  
Routine Care ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Vitamin Supplement ◽  
Significant Difference ◽  
Post Test ◽  
Knowledge And Attitude

ABSTRACT Objectives: to evaluate the effectiveness of educational intervention in the knowledge and attitude of candidates for gastroplasty. Methods: randomized controlled clinical trial with 56 preoperative patients (intervention=28; control=28). The control group received routine care from the health institution and the intervention group participated in a book-mediated educational intervention. Forms were used for clinical-epidemiological characterization and evaluation of knowledge/attitude about bariatric surgery, which were reapplied seven weeks after intervention. RBR-297fzx. Results: in the pre-test there was no significant difference between the groups (p=0.254). In the post-test, the group that received verbal guidance had a mean score of 19.5 (± 6.17) and the group reading the booklet averaged 31.1 (± 2.96), p=0.000. The attitude is adequate, especially for care such as vitamin supplement intake, water intake and physical activity practice. Conclusions: the educational intervention mediated by booklet was effective in improving knowledge and attitude when compared to verbal guidance. Thus, it can be replicated during the preoperative preparation.

scholarly journals The effect of transcutaneous auricular stimulation on anxiety before colposcopy: A randomized clinical trial

2020 ◽  
Vol 37 (4) ◽  
pp. 405-415
Author(s):  
Samaneh Jouya ◽  
Nahid Golmakani
Keyword(s):  
Clinical Trial ◽  
State Anxiety ◽  
Intervention Group ◽  
Routine Care ◽  
T Test ◽  
Anxiety Level ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Significant Difference

Women experience a high level of anxiety and negative emotional responses during colposcopy, which results in women's' unwillingness to return for follow-up. Transcutaneous auricular stimulation may be useful in reducing anxiety. Therefore, the aim of this study was to determine the effect of transcutaneous auricular stimulation on anxiety before colposcopy. This randomized controlled clinical trial study was performed on 65 female candidates for colposcopy who were referred to Ghaem Hospital, Mashhad, Iran, in 2017. Women were randomized into one of the two groups. In the intervention group, a pointer Excel device was used for forty minutes before colposcopy; electrical stimulation at 4 points (Shenmen, relaxation, tranquillizer and endocrine) was performed on ears, with the frequency of 2 Hz for 30 seconds at each point. Women received routine care in the control group. The anxiety level was assessed by Spielberger Questionnaire before intervention and also 40 minutes after intervention. Data analysis was performed using the t-test, paired t-test, and MannWhitney test in SPSS software, version16. P value less than 0.05 was considered significant. After intervention, the state anxiety score was 43.9 ± 9.19 in the control group and 54.3 ± 9.07 in the intervention group, and the difference between the two groups was statistically significant (P = 0.00), while there was no significant difference in the level of trait anxiety in the two groups (P = 0.21). Regarding the reduction of state anxiety level after intervention, transcutaneous auricular stimulation is recommended as a suitable method to reduce anxiety of patients who are candidates for colposcopy.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

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 Effects of fenugreek seed powder on enteral nutrition tolerance and clinical outcomes in critically ill patients: A randomized clinical trial

2018 ◽  
Vol 5 (7) ◽  
pp. 2528-2537
Author(s):  
Akram Kooshki ◽  
Zaher Khazaei ◽  
Azam Zarghi ◽  
Mojtaba Rad ◽  
Hadi Gholam Mohammadi ◽  
...  
Keyword(s):  
Enteral Nutrition ◽  
Clinical Outcomes ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Routine Care ◽  
Fenugreek Seeds ◽  
Mechanically Ventilated ◽  
Fenugreek Seed ◽  
Group 2 ◽  
Group 1

Background: Enteral nutrition (EN) intolerance is a common complication in critically ill patients that contributes to morbidity and mortality. Based on the evidence of curing effects of fenugreek seeds in some gastrointestinal disorders, this study aimed to determine the effects of fenugreek seed powder on enteral nutrition tolerance and clinical outcomes in critically ill patients. Materials & Methods: A randomized, double-blinded clinical trial of 5-day duration was conducted on 60 mechanically ventilated patients divided in 2 groups (n=30). Group 1 was given fenugreek seed powder by gavage, twice a day in addition to routine care, while Group 2 received only routine care. Enteral nutrition tolerance and clinical outcomes were measured throughout the study. Demographic and clinical data were recorded and clinical responses to the primary outcome (enteral nutrition tolerance) and secondary outcome (other clinical factors) were interpreted. Data were analyzed using the independent t-test, Chi-squared test, covariance analysis, and repeated measure ANOVA via SPSS statistical software (v. 20); statistical significance was set at p< 0.05. Results: Patients who were fed with the fenugreek seed powder showed a significant improvement in enteral nutrition tolerance, as well as some complications of mechanical ventilation for Group 1, as compared with Group 2. The mortality rates were not different between the two groups. Conclusion: This study shows the beneficial effects of fenugreek seeds on food intolerance in critically ill patients and that the seed powder can be used as an add-on therapy with other medications. Thus, the use of fenugreek seeds to treat mechanically ventilated patients is recommended.

scholarly journals Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 929
Author(s):  
Nouran Hesham El-Sherazy ◽  
Naglaa Samir Bazan ◽  
Sara Mahmoud Shaheen ◽  
Nagwa A. Sabri
Keyword(s):  
Ascorbic Acid ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Statistical Significance ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Control Groups ◽  
The Absolute ◽  
And Control

Background Antioxidants show nephroprotective effect against vancomycin associated nephrotoxicity (VAN) in animals. This study aimed to assess the ascorbic acid nephro-protective role against VAN clinically. Methods Forty-one critically ill patients were randomly assigned to one of two groups: intervention group (vancomycin IV plus ascorbic acid, n=21) or control group (vancomycin IV only, n=20). Primary outcomes were the incidence of VAN and the absolute change in creatinine parameters, while mortality rate was the secondary outcome. Nephrotoxicity was defined as an increase in serum creatinine (S.cr) by at least 0.5 mg/dL or 50% of baseline for at least two successive measurements. This study is registered at Clinicaltrials.gov (NCT03921099), April 2019. Results Mean absolute S.cr increase was significant when compared between both groups, P-value = 0.036, where S.cr increased by 0.05(0.12) and 0.34(0.55) mg/dL in the intervention and control groups, respectively. Mean absolute Cr.cl decline was significant when compared between both groups, P-value = 0.04, where Cr.cl was decreased by 5.9(17.8) and 22.3(30.4) ml/min in the intervention and control groups, respectively. Incidence of VAN was 1/21(4.7%) versus 5/20(25%) in the intervention and control groups, respectively (RR: 0.19; CI: 0.024–1.49; P-value = 0.093). Mortality was higher in the control group; however, it was not statistically significant, P-value = 0.141. Conclusion Co-administration of ascorbic acid with vancomycin preserved renal function and reduced the absolute risk of VAN by 20.3%, however, the reduction in VAN incidence didn’t reach statistical significance level. Further large multicenter prospective trials are recommended.

scholarly journals Physical methods for the treatment of fever in critically ill patients: a randomized controlled trial

2016 ◽  
Vol 50 (5) ◽  
pp. 823-830 ◽  
Author(s):  
Patrícia de Oliveira Salgado ◽  
Ludmila Christiane Rosa da Silva ◽  
Priscila Marinho Aleixo Silva ◽  
Tânia Couto Machado Chianca
Keyword(s):  
Body Temperature ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Intervention Group ◽  
Tympanic Temperature ◽  
Control Group ◽  
Physical Methods ◽  
Group I ◽  
Significant Difference ◽  
Ice Pack

Abstract OBJECTIVE To evaluate the effects of physical methods of reducing body temperature (ice pack and warm compression) in critically ill patients with fever. METHOD A randomized clinical trial involving 102 adult patients with tympanic temperature ≥ 38.3°C of an infectious focus, and randomized into three groups: Intervention I - ice pack associated with antipyretic; Intervention II - warm compress associated with antipyretic; and Control - antipyretic. Tympanic temperature was measured at 15 minute intervals for 3 hours. The effect of the interventions was evaluated through the Mann-Whitney test and Survival Analysis. "Effect size" calculation was carried out. RESULTS Patients in the intervention groups I and II presented greater reduction in body temperature. The group of patients receiving intervention I presented tympanic temperature below 38.3°C at 45 minutes of monitoring, while the value for control group was lower than 38.3°C starting at 60 minutes, and those who received intervention II had values lower than 38.3°C at 75 minutes of monitoring. CONCLUSION No statistically significant difference was found between the interventions, but with the intervention group I patients showed greater reduction in tympanic temperature compared to the other groups. Brazilian Registry of Clinical Trials: RBR-2k3kbq

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