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 No patients were withdrawn from the study because of adverse effects.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.

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 Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

2020 ◽  
Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Strong Dependence ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Control Group ◽  
Standard Of Care Treatment ◽  
And Control ◽  
To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

scholarly journals The Effects of Manual Lung Hyperinflation on Pulmonary Function after Weaning from Mechanical Ventilation among Patients with Abdominal Surgeries: Randomized Clinical Trial

2021 ◽  
Vol 10 (4) ◽  
pp. 216-222
Author(s):  
Mahboube Yazdani ◽  
Javad Malekzadeh ◽  
Alireza Sedaghat ◽  
Seyed Reza Mazlom ◽  
Aliyeh Pasandideh khajebeyk
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Abdominal Surgery ◽  
Pulmonary Function ◽  
Randomized Clinical Trial ◽  
Arterial Oxygen ◽  
Control Group ◽  
Artificial Airway ◽  
Rapid Shallow Breathing Index ◽  
Significant Difference

Introduction: After abdominal surgery, the patients who are separated from mechanical ventilation and provided with oxygen therapy via a T-piece are at risk for respiratory complications. Therefore, they need additional respiratory support. This study aimed to evaluate the effects of manual hyperinflation (MHI) on pulmonary function after weaning. Methods: This randomized clinical trial included 40 patients who had undergone abdominal surgery and were receiving oxygen via a T-piece. Patients were selected from the intensive care units (ICU) of two hospitals in Mashhad, Iran. The subjects were randomly allocated to intervention (MHI) and control groups. Patients in the MHI group were provided with three 20-minute MHI rounds using the Mapleson C, while the control group received routine cares. Tidal volume (Vt), Rapid Shallow Breathing Index (RSBI), and the ratio of arterial oxygen partial pressure to fractional inspired oxygen (P/F ratio) were measured before the intervention, as well as 5 and 20 minutes after the intervention. Atelectasis prevalence was assessed before and 24 hours after the intervention. Data were analysed by SPSS software version 13. Results: At baseline, there were no significant differences between the groups regarding Vt, RSBI, P/F ratio, and atelectasis rate. No significant difference was also found between the groups regarding atelectasis rate 24 hours after the intervention. However, at both posttests, Vt, RSBI, and P/F ratio in the MHI group were significantly better than the control group. Conclusion: In patients with artificial airway and spontaneous breathing, MHI improves pulmonary function.

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.

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.

Evaluation of anti-psoriatic activity of selected phytochemicals on UV-induced psoriasis in mouse tail model

2020 ◽  
Vol 64 ◽  
pp. 123-128
Author(s):  
Jada Naga Lakshmi ◽  
A. Narendra Babu ◽  
Rama Rao Nadendla
Keyword(s):  
Disease Control ◽  
Ellagic Acid ◽  
Uv Light ◽  
Severity Index ◽  
Treated Group ◽  
Control Group ◽  
Standard Group ◽  
Significant Activity ◽  
Epidermal Thickness ◽  
Psoriasis Severity

Objectives: To evaluate anti-psoriatic activity of Phytochemicals on UV-Induced psoriasis in mouse tail model. Materials and Methods: Anti-psoriatic activity of selected phytochemicals on UV-Induced psoriasis in mouse tail model. The animals were dividing into 05 groups and each group contain 5 animals. Disease control group did not receive any treatment only exposure to UV-light, vehicle control treated with simple ointment, standard group treated with salicylic acid (1%w/w) ointment, remaining group are treated 1% and 2% selective phytochemical at two concentrations of ointment to topically on the tail skin. And the data were analysed using one way ANOVA followed by two-way ANOVA (Dunnett’s multiple comparisons test). Results: There was significant decrease in epidermal thickness (P < 0.05) as compared with control group. In 2% phytoconstituents has shown a significant reduction in the total epidermal thickness 8.4****±0.748, 7.6**±0.6781 and 8*±0.8366 in geraniol, glycyrrhizic acid and ellagic acid treated group, when compare to the disease induced animal, there was no lesion of Munro’s microabscess, capillary loop dilation along with elongation of rete ridges in the section of skin of rats. Psoriasis Severity Index was reduced in test treated groups as compared with that of disease control group. It was slowly reduced to 2nd week, totally (55-70%) reduction in PSI is observed at the time of third week of treatment period. Conclusion: The result of the study showed that the 2% of geraniol, ellagic acid, glycyrrhizicacid and hesperidin, exhibited significant activity on UV-induced psoriasis in rodents. The study implies that selected phytoconstituents are a promising research for further investigations to prove its anti-psoriatic activity.

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.

Sign in / Sign up

Export Citation Format

Share Document