scholarly journals The effect of supplementation with vitamins A, B, C, D, and E on disease severity and inflammatory responses in patients with COVID-19: a randomized clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mohammad Taghi Beigmohammadi ◽  
Sama Bitarafan ◽  
Azin Hoseindokht ◽  
Alireza Abdollahi ◽  
Laya Amoozadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mortality Rate ◽  
Sofa Score ◽  
Inflammatory Responses ◽  
Intervention Group ◽  
Serum Levels ◽  
Control Group ◽  
Inverse Association ◽  
Prolonged Hospitalization ◽  
Duration Of Hospitalization

Abstract Background and objective Because of the effect of vitamins on modulating the immune system function, we have evaluated the effect of supplementation with vitamins A, B, C, D, and E in ICU-admitted patients with COVID-19. Methods This study was a randomized and single-blinded clinical trial in which 60 subjects were randomly assigned to two groups. The intervention group (n=30) received vitamins, and the control group did not receive any vitamin or placebo. The intervention was included 25,000 IU daily of vitamins A, 600,000 IU once during the study of D, 300 IU twice daily of E, 500 mg four times daily of C, and one amp daily of B complex for 7 days. At baseline and after the 7-day intervention, the serum levels of inflammatory markers, vitamins, and the SOFA score were assessed. In addition, the mortality rate and duration of hospitalization were evaluated after the intervention (IRCT registration number: IRCT20200319046819N1/registration date: 2020-04-04, https://www.irct.ir/trial/46838). Results Significant changes were detected in serum levels of vitamins (p < 0.001 for all vitamins), ESR (p < 0.001), CRP (p = 0.001), IL6 (p = 0.003), TNF-a (p = 0.001), and SOFA score (p < 0.001) after intervention compared with the control group. The effect of vitamins on the mortality rate was not statistically significant (p=0.112). The prolonged hospitalization rate to more than 7 days was significantly lower in the intervention group than the control group (p=0.001). Regarding the effect size, there was a significant and inverse association between receiving the intervention and prolonged hospitalization (OR = 0.135, 95% CI 0.038–0.481; p=0.002); however, after adjusting for confounders, it was not significant (OR=0.402, 95% CI 0.086–1.883; p=0.247). Conclusion Supplementation with vitamins A, B, C, D, and E could improve the inflammatory response and decrease the severity of disease in ICU-admitted patients with COVID-19.

scholarly journals The effect of acetazolamide on intracerebral hemorrhage in stoke patients

2017 ◽  
Vol 4 (1) ◽  
pp. 148
Author(s):  
Vahid Abbasi ◽  
Maryam Salimi ◽  
Firouz Amani
Keyword(s):  
Clinical Trial ◽  
Mortality Rate ◽  
Intervention Group ◽  
Cerebral Haemorrhage ◽  
Haemorrhagic Stroke ◽  
Symptom Improvement ◽  
Control Group ◽  
Stroke Patients ◽  
The World ◽  
The Status

Background: 10-20% of all strokes are caused by intracerebral haemorrhage which is the world's leading cause of neural tube defects and the second cause of mortality in the world. The aim of this study was to assessment the effect of acetazolamide in the symptom improvement, decreasing rankin scale and mortality rate in patients with intracerebral haemorrhage.Methods: This is a clinical trial study that has been done on 120 stroke patients which divided randomly in two groups each with 60 patients. Patients in intervention group take acetazolamide 750 mg/day and in control group take placebo. The status of patients investigated by Rankin scale in three times baseline, 72 hours and 3 weeks after Cerebral haemorrhage.Results: Of all patients, 49 (40.8%) were male and 71 (59.1%) were female. Putamen haemorrhage is the most location for cerebral haemorrhage (n = 43, 35.8%). According to the Rankin scale, 53 (44.2%) of patients were in the status 4 “moderately severe disability. Unable to attend to own bodily needs without assistance and unable to walk unassisted” in baseline. In the intervention group based on Rankin scale after 72 hour and three week the recovery rate was significantly more than control group.Conclusions: Acetazolamide can be effective in treatment haemorrhagic stroke, decreasing Rankin scale and mortality rate in patients with cerebral haemorrhage.

scholarly journals Interleukin-31 Serum And Pruritus Dimension After Acupuncture Treatment In Hemodialysis Patients: A Randomized Clinical Trial

2021 ◽  
Vol 9 (B) ◽  
pp. 196-201
Author(s):  
Dedi Ardinata ◽  
Rozaimah Zain-Hamid ◽  
Irma. D. Roesyanto-Mahadi ◽  
Hasan Mihardja
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Serum Levels ◽  
Hemodialysis Patients ◽  
Control Group ◽  
Placebo Control ◽  
Limited Information ◽  
Before And After ◽  
The Impact

BACKGROUND: Interleukin (IL)-31 serum levels were significantly higher in hemodialysis patients with pruritus, whereas acupuncture in LI11 was shown to improve symptoms of pruritus. However, there is limited information that IL-31 serum levels that correlate with decreased dimensions of the pruritus after acupuncture in LI11 in a hemodialysis patient. AIM: The aim of the study was to demonstrate the impact of acupuncture in LI11 and IL-31 serum level and its correlation with dimensions of the pruritus in hemodialysis patients. METHODS: A randomized clinical trial has been carried out from August 2019 to December 2019 at H. Adam Malik General Hospital, Medan, Indonesia. Sixty patients underwent hemodialysis who were randomly allocated to two groups, one group got acupuncture in Quchi LI11 (intervention group), and the other group got a placebo (control group). IL-31 serum levels and pruritus were measured before and after 6 weeks of acupuncture in both groups. RESULTS: Acupuncture did not significantly reduce IL-31 (p = 0.931) and decreased dimensions: Degree, duration, disability, and distribution of the pruritus between the intervention group and the control group after 6 weeks of acupuncture in LI11. It can be shown that there is no significant correlation between IL-31 serum levels and dimensions of the pruritus. CONCLUSION: This study demonstrates the effect of acupuncture on reducing dimensions of the pruritus not related to IL-31 serum levels. Identifying the action mechanism of acupuncture to minimize pruritus considerably enhances knowledge of the impacts of acupuncture on reducing pruritus in hemodialysis patients.

scholarly journals New therapy for chemotherapy-induced hepatic failure in leukemia; a randomized double-blind clinical trial study

2020 ◽  
Vol 7 (2) ◽  
pp. e16-e16
Author(s):  
Farid Ghazizadeh ◽  
Mehran Noroozi ◽  
Parvaneh Shadara ◽  
Javad Rasouli ◽  
Sasan Hejazi
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Lymphoblastic Leukemia ◽  
Intervention Group ◽  
Serum Levels ◽  
Control Group ◽  
Milk Thistle ◽  
Double Blind Study ◽  
Double Blind ◽  
Effective Role

Introduction: Hepatotoxicity is usual toxicity after chemotherapy in acute lymphoblastic leukemia (ALL) patients. Conventional treatment methods such as supportive care did not have an effective role in the improvement of hepatotoxicity. Objectives: In this study clinical efficacy of milk thistle in contrast with placebo was compared in leukemia patients with chemotherapy-induced hepatotoxicity. Patients and Methods: In this double-blind study, 93 ALL patients with chemotherapy-induced hepatotoxicity were randomized to a clinical trial with milk thistle or placebo. Liver enzymes level evaluated during 70 days. We divided patients randomly into two groups. Milk thistle at dosage of 7 mg/kg daily was prescribed in the intervention group while in the control group, placebo pills similar to milk thistle in shape and color were prescribed daily. Results: At day 35 and day 70 of the study, in the milk thistle arm ALT and AST mean serum levels were lower than the placebo group (P<0.001). In the milk thistle group there was a significant reduction in mean of AST and ALT during the first 35 days in patients who were taking livergol in comparison to next 35 days that patients stopped taking it. Children’s age was between 3-15 years. Conclusion: Based on our results, milk thistle improves liver function in chemotherapy-induced hepatotoxicity and there was no need for dose reduction or discontinuation of chemotherapy. Future clinical trials should be conducted to explore longtime effect of livergol in leukemia patients and to determine if there is any need for prophylactic administration of antioxidants. Trial Registration: This clinical trial has been approved by the Iranian Registry of Clinical Trials at 2018-02-14 (identifier: IRCT20170821035831N2; http://en.irct.ir/trial/26957).

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.

Effect of Dietary Education on Cardiovascular risk Factors in Rheumatoid Arthritis Patients

2020 ◽  
Vol 16 ◽  
Author(s):  
Rahil Taheri ◽  
Shahram Molavynejad ◽  
Parvin Abedi ◽  
Elham Rajaei ◽  
Mohammad Hosein Haghighizadeh
Keyword(s):  
Rheumatoid Arthritis ◽  
Risk Factors ◽  
Blood Pressure ◽  
Cardiovascular Risk ◽  
Cardiovascular Risk Factors ◽  
Statistical Tests ◽  
Intervention Group ◽  
Serum Levels ◽  
Control Group ◽  
Dietary Education

Aim: The aim of this study was to investigate the effect of dietary education on cardiovascular risk factors in patients with rheumatoid arthritis. Method: In this randomized clinical trial, 112 patients with rheumatoid arthritis were randomly assigned into two groups, intervention and control. Dietary education was provided for the intervention group in 4 sessions; anthropometric measurements, serum levels of RF, triglycerides, cholesterol, HDL, LDL, and fasting blood sugar were measured before and three months after intervention. Data was analyzed using SPSS software and appropriate statistical tests. Results: The mean of total cholesterol (p <0.001), triglycerides (p = 0.004), LDL (p <0.001), systolic blood pressure (p = 0.001), diastolic blood pressure (p = 0.003), FBS and BMI (p <0.001) were decreased significantly in the intervention group after education compared the control group. Conclusion: Traditional care for rheumatoid arthritis patients is not enough. Patients need more education in order to improve their situation.

Immunosuppression medication adherence after allogeneic hematopoietic stem cell transplant: Impact of a specialized clinical pharmacy program

2021 ◽  
pp. 107815522110001
Author(s):  
Florent Charra ◽  
Michael Philippe ◽  
Chloé Herledan ◽  
Anne-Gaëlle Caffin ◽  
Virginie Larbre ◽  
...  
Keyword(s):  
Clinical Pharmacy ◽  
Hematopoietic Stem Cell Transplant ◽  
Acute Gvhd ◽  
Intervention Group ◽  
Serum Levels ◽  
Control Group ◽  
Cell Transplant ◽  
Drug Adherence ◽  
Hematopoietic Stem ◽  
Discharge Prescription

This study aims to evaluate the impact of implementing a specialized clinical pharmacy program in patients with allogeneic hematopoietic stem cell transplant (HSCT) on their adherence to the immunosuppression treatment after discharge. A prospective open interventional design using a retrospective control group was used. The intervention was based on pharmaceutical consultations: the first was performed the day before discharge of HSCT unit and the next consultations during day-care follow-up (weeks 2 and 4 after discharge). Proactive medication reconciliation was implemented with a complete list of medications before the discharge prescription. The discharge prescription summarized on a personalized drug schedule was explained to the patient. The importance of optimal adherence and the potential problems related to self-medication were explained to the patient. Immunosuppression drug adherence was assessed by a direct method using serum levels of calcineurin inhibitors. The potential impact on acute GvHD, and infection was investigated. Twenty-six patients were included in the specialized clinical pharmacy program and 35 patients were in the control group. Seventy-nine pharmaceutical consultations were conducted in the intervention group, lasting a mean 25 min and 16 min for the first and following consultations, respectively. Serum levels in the therapeutic target range were higher in the intervention group (61.5% versus 53.0%, p = 0.07), with greater intra-individual variation (p = 0.005). There was no significant intergroup difference in acute GvHD (53.8% versus 50.3%, p = 0.85) or infection (26.9 versus 22.8%, p = 0.72). The implementation of a specialized clinical pharmacy program for patients who have received allogeneic HSCT seems to be beneficial for immunosuppression drug adherence; this now needs to be confirmed in a multicenter study involving a larger number of patients.

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.

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.

Capnography and Pulse Oximetry Improve Fast Track Extubation in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Seyed Tayeb Moradian ◽  
Fatemah Beitollahi ◽  
Mohammad Saeid Ghiasi ◽  
Amir vahedian-azimi
Keyword(s):  
Clinical Trial ◽  
Pulse Oximetry ◽  
Fast Track ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Intervention Group ◽  
Control Group ◽  
Artery Bypass Graft ◽  
Cabg Surgery ◽  
Non Invasive

Abstract Background Use of capnography as a non-invasive method during the weaning process for fast track extubation (FTE) is controversial. We conducted the present study to determine whether pulse oximetry and capnography could be utilized as alternatives to arterial blood gas (ABG) measurements in patients under mechanical ventilation (MV) following coronary artery bypass graft (CABG) surgery. Methods In this randomized clinical trial, 70 patients, who were candidates for CABG surgery, were randomly assigned into two equal groups (n = 35); the intervention group and the control group. In the intervention group, the ventilator management and weaning from MV was done using Etco2 from capnography and SpO2 from pulse oximetry. Meanwhile, in the control group, weaning was done based on ABG analysis. The length of intensive care unit (ICU) stay, time to extubation, number of manual ventilator setting changes, and alarms were compared between the groups. Results The end-tidal carbon dioxide (ETCO2) levels in the intervention group were completely similar to the partial pressure of carbon dioxide (PaCo2) in the control group (39.5 ± 3.1 vs. 39.4 ± 4.32, P > 0.05). The mean extubation times were significantly shorter in the intervention group compared to those in the control patients (212.2 ± 80.6 vs. 342.7 ± 110.7, P < 0.001). Moreover, the number of changes in the manual ventilator setting and the number of alarms were lower in the intervention group (P < 0.05). However, the differences in the length of stay in ICU between the two groups were not significant (P = 0.219). Conclusion According to our results, the use of non-invasive monitors, including capnography and pulse oximetry, is emphasized in order to utilize FTE after CABG surgery. Furthermore, it is a safe and valuable monitor that could be a good alternative for ABG in this population. Nevertheless, further studies with larger sample sizes and on different disease states and populations are required to assess the accuracy of our findings. Trial registration: IRCT, IRCT201701016778N6, Registered 3 March 2017, https://www.irct.ir/trial/7192

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