Melatonin reduces the mortality of severely-infected COVID-19 patients

2021 ◽  
Vol 4 (4) ◽  
pp. 613-616
Author(s):  
Dun-Xian Tan ◽  
Russel J Reiter
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Mortality Rate ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Mortality Reduction ◽  
Single Center ◽  
Open Label ◽  
Melatonin Treatment ◽  
The World

SARS-CoV-2 has ravaged the population of the world for two years. Scientists have not yet identified an effective therapy to reduce the mortality of severe COVID-19 patients. In a single-center, open-label, randomized clinical trial, it was observed that melatonin treatment lowered the mortality rate by 93% in severely-infected COVID-19 patients compared with the control group (see below). This is seemingly the first report to show such a huge mortality reduction in severe COVID-19 infected individuals with a simple treatment. If this observation is confirmed by more rigorous clinical trials, melatonin could become an important weapon to combat this pandemic.

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 Effect of bromhexine on clinical outcomes and mortality in COVID-19 patients: A randomized clinical trial

Bioimpacts ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. 209-215 ◽  
Author(s):  
Khalil Ansarin ◽  
Ramin Tolouian ◽  
Mohammadreza Ardalan ◽  
Ali Taghizadieh ◽  
Mojtaba Varshochi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Positive Impact ◽  
Therapeutic Option ◽  
Treated Group ◽  
Control Group ◽  
Standard Group ◽  
Open Label ◽  
North West

Introduction: Bromhexine is a potential therapeutic option in COVID-19, but no data from a randomized clinical trial has been available. The present study aimed to evaluate the efficacy of bromhexine in intensive care unit (ICU) admission, mechanical ventilation, and mortality in patients with COVID-19. Methods: An open-label randomized clinical trial study was performed in Tabriz, North-West of Iran. They were randomized to either the treatment with the bromhexine group or the control group, in a 1:1 ratio with 39 patients in each arm. Standard therapy was used in both groups and those patients in the treatment group received oral bromhexine 8 mg three times a day additionally. The primary outcome was a decrease in the rate of ICU admissions, intubation/mechanical ventilation, and mortality. Results: A total of 78 patients with similar demographic and disease characteristics were enrolled. There was a significant reduction in ICU admissions (2 out of 39 vs. 11 out of 39, P = 0.006), intubation (1 out of 39 vs. 9 out of 39, P = 0.007) and death (0 vs. 5, P = 0.027) in the bromhexine treated group compared to the standard group. No patients were withdrawn from the study because of adverse effects. Conclusion: The early administration of oral bromhexine reduces the ICU transfer, intubation, and the mortality rate in patients with COVID-19. This affordable medication can easily be administered everywhere with a huge positive impact(s) on public health and the world economy. Altogether, the verification of our results on a larger scale and different medical centers is strongly recommended. Trial Registration: IRCT202003117046797N4; https://irct.ir/trial/46969.

scholarly journals A Pilot Randomized Clinical Trial: Oral Miltefosine and Pentavalent Antimonials Associated With Pentoxifylline for the Treatment of American Tegumentary Leishmaniasis

2021 ◽  
Vol 11 ◽  
Author(s):  
Sofia Sales Martins ◽  
Daniel Holanda Barroso ◽  
Bruna Côrtes Rodrigues ◽  
Jorgeth de Oliveira Carneiro da Motta ◽  
Gustavo Subtil Magalhães Freire ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Treatment Options ◽  
Treatment Interruption ◽  
Control Group ◽  
Open Label ◽  
Need For Treatment ◽  
Tegumentary Leishmaniasis ◽  
Wide Range ◽  
American Tegumentary Leishmaniasis

IntroductionAmerican tegumentary leishmaniasis (ATL), which can present as either cutaneous (CL) or mucosal leishmaniasis (ML), is endemic in South America, and first-line antimonial treatments are known for their wide range of adverse effects (AEs). Growing reports of drug resistance increase the urgency of the need for better treatment options. The objective of this pilot clinical trial was to assess the efficacy of and AEs associated with the oral combination of miltefosine and pentoxifylline based on a post hoc analysis.MethodsA pilot, randomized, open-label clinical trial was performed. The experimental group (M+P) received 50 mg twice a day (BID) miltefosine and 400 mg three times a day (TID) pentoxifylline, and the control group (A+P) received 20 mg Sb+V/kg/day intravenously and 400 mg TID pentoxifylline. Patients with ML received treatment for 28 days, and patients with CL received treatment for 20 days.ResultsForty-three patients were included: 25 with ML and 18 with CL caused by L.(V.) braziliensis. AEs were more frequent in the A+P group (p=0.322), and there was a need for treatment interruption due to severe AEs (p=0.027). Patients with CL had a higher chance of achieving a cure (p=0.042) and a higher risk of AEs (p=0.033). There was no difference in the chance of a cure based on the treatment (p=0.058).ConclusionIn this pilot randomized clinical trial, M+P treatment and A+P treatment yielded similar cure rates, and the former was associated with a lower risk of AEs. Future studies with more patients and longer follow-up are recommended.

scholarly journals The effect of letrozole versus artificial hormonal endometrial preparation on pregnancy outcome after frozen-thawed embryos transfer cycles: a randomized clinical trial

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Azadeh Hosseini-Najarkolaei ◽  
Ashraf Moini ◽  
Ladan Kashani ◽  
Maryam Farid Mojtahedi ◽  
Elnaz Hosseini-Najarkolaee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Current Evidence ◽  
Control Group ◽  
Human Menopausal Gonadotropin ◽  
Widespread Application ◽  
Link Type ◽  
Endometrial Preparation

Abstract Background Considering that clinical trial studies are limited in polycystic ovary syndrome (PCOS) patients, and there is no consensus on an optimum endometrial preparation protocol for frozen embryo transfer (FET), the present study was designed as a randomized clinical trial to compare the reproductive outcomes following stimulated cycles with letrozole plus human menopausal gonadotropin (HMG) for endometrial preparation compared with routine AC-FET. Methods This randomized controlled trial was carried out on infertile PCOS patients who underwent IVF/ICSI and FET cycles in Arash Women’s Hospital affiliated to Tehran University of Medical Sciences between September 2018 and January 2020. PCOS diagnosis was based on the Rotterdam criteria. Eligible patients were randomly allocated into two groups: stimulated cycle with letrozole plus (HMG) (intervention group) and routine artificial hormonal endometrial preparation (control group). Results One hundred seventy-seven infertile patients were recruited for participation in the study. Of these, 57 women were excluded due to non-eligibility for entering the study, and a total of 120 patients were randomly assigned to two study groups. After follow up, the cycle outcomes of 57 patients in the intervention group and 59 patients in the control group were compared. The data analysis showed that the two groups did not have significant differences in fundamental and demographic characteristics. After the intervention, there were no significant differences in implantation rate, chemical, ectopic, and clinical pregnancy rates between groups. Moreover, the rates of miscarriage and ongoing pregnancy were similar between groups (P > 0.05). Conclusions We found similar pregnancy outcomes with two endometrial preparation methods. Noting that each treatment centre should select the most beneficial and cost-effective method with the least adverse effects for patients, letrozole preparations for FET could be incorporated into possible options; however, establishing this approach as first-line treatment is premature in light of current evidence, and future randomized clinical trials with larger sample sizes are required for widespread application. Trial registration The study was also registered in the Iranian Registry of Clinical Trials on March 20th, 2020. (IRCT20090526001952N12 at www.irct.ir, registered retrospectively).

Effect of Chicken Extract on Breast Milk Production in Primiparous Mothers in Japan: A Randomized Clinical Trial

2021 ◽  
Vol 16 (1) ◽  
pp. 16-21
Author(s):  
M. Awano ◽  
K. Koike ◽  
T. Sawada ◽  
XU FengHao ◽  
N. Suzuki
Keyword(s):  
Clinical Trial ◽  
Breast Milk ◽  
Randomized Clinical Trial ◽  
Milk Production ◽  
Intervention Group ◽  
Control Group ◽  
Open Label ◽  
Breast Milk Production ◽  
Early Postpartum ◽  
Before And After

The purpose of this study was to assess the effects of chicken extract on breast milk production and fatigue in early postpartum women. The study is an open-label parallel-group randomized clinical trial involving 80 healthy primiparous women from Japan divided into two groups. The intervention group ingested chicken extract twice daily for more than two weeks and the control group ingested water. The effectiveness of chicken extract on breast milk production after delivery and quality of life before and after delivery was examined. The result showed that milk production in the chicken extract group (356±191mL) was higher than in the control group (279±142mL) at 96-120h, but not significantly different (P=0.071). Expressed milk production had increased significantly more at 96-120h in the chicken extract group (122.6±115.5mL) than in the control group (66.5±55.8mL) (P=0.017). Chicken extract significantly reduced fatigue at 38 weeks after gestation, as assessed by visual analog scale (P=0.006). The study concluded that milk production increased more in the intervention group. It is suggesting that the chicken extract may be effective in increasing breast milk production and reducing fatigue in later stage of gestation.

scholarly journals Review of Current Evidence of Hydroxychloroquine in Pharmacotherapy of COVID-19

2020 ◽  
Author(s):  
Umesh Devappa Suranagi ◽  
Harmeet Singh Rehan ◽  
Nitesh Goyal
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
In Vitro Study ◽  
Human Studies ◽  
Current Evidence ◽  
Viral Inhibition ◽  
Open Label ◽  
Clinical Trial Registries ◽  
The World

ABSTRACTImportanceThe COVID-19 Pandemic has literally left the world breathless in the chase for pharmacotherapy. With vaccine and novel drug development in early clinical trials, repurposing of existing drugs takes the center stage.ObjectiveA potential drug discussed in global scientific community is hydroxychloroquine. We intend to systematically explore, analyze, rate the existing evidence of hydroxychloroquine in the light of published, unpublished and clinical trial data.Evidence reviewPubMed Ovid MEDLINE, EMBASE, Google scholar databases, pre-proof article repositories, clinical trial registries were comprehensively searched with focused question of use of hydroxychloroquine in COVID-19 patients. The literature was systematically explored as per PRISMA guidelines.FindingsTotal 139 articles were available as of 25th April 2020; of which 10 articles of relevance were analyzed. Three in-vitro studies were reviewed. Two open label non-randomized trials, two open label randomized control trials, one follow-up study and two retrospective cohort studies were systematically analyzed and rated by oxford CEBM and GRADE framework for quality and strength of evidence. Also 27 clinical trials registered in three clinical trial registries were analyzed and summarized. Hydroxychloroquine seems to be efficient in inhibiting SARS-CoV-2 in in-vitro cell lines. However, there is lack of strong evidence from human studies. It was found that overall quality of available evidence ranges from ‘very low’ to ‘low’.Conclusions and relevanceThe in-vitro cell culture based data of viral inhibition does not suffice for the use of hydroxychloroquine in the patients with COVID-19. Current literature shows inadequate, low level evidence in human studies. Scarcity of safety and efficacy data warrants medical communities, health care agencies and governments across the world against the widespread use of hydroxychloroquine in COVID-19 prophylaxis and treatment, until robust evidence becomes available.KEY POINTSQuestionWhat is the current evidence for use of Hydroxychloroquine in pharmacotherapy of COVID-19?FindingsWe electronically explored various databases and clinical trial registries and identified 10 publications and 27 clinical trials with active recruitment. The in-vitro study data demonstrates the viral inhibition by hydroxychloroquine. The clinical studies are weakly designed and conducted with insufficient reporting and significant limitations. Well designed robust clinical trials are being conducted all over the world and results of few such robust studies are expected shortly.MeaningCurrent evidence stands inadequate to support the use of hydroxychloroquine in pharmacotherapy of COVID-19.

scholarly journals Effects of a positive thinking program on hope and sleep quality in Iranian patients with thalassemia: a randomized clinical trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Somayeh Makaremnia ◽  
Marieh Dehghan Manshadi ◽  
Zahra Khademian
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Training Program ◽  
Randomized Clinical Trial ◽  
Thalassemia Major ◽  
Trial Registration ◽  
Control Group ◽  
Positive Thinking ◽  
Experimental Group

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.

scholarly journals Intraoperative protective ventilation in patients undergoing major neurosurgical interventions: a randomized clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Federico Longhini ◽  
Laura Pasin ◽  
Claudia Montagnini ◽  
Petra Konrad ◽  
Andrea Bruni ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Outcome ◽  
Adverse Events ◽  
Respiratory Rate ◽  
Randomized Clinical Trial ◽  
Protective Ventilation ◽  
Adult Patients ◽  
Control Group ◽  
Neurosurgical Procedures ◽  
Neurosurgical Patients

Abstract Background Post-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery. Methods This single-centre, pilot randomized clinical trial was conducted at the University Hospital “Maggiore della Carità” (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6–8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality. Results A total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups. Conclusions LPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements. Trial registration registered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), registration number ACTRN12615000707561.

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