scholarly journals Efficacy and safety of novel herbal tablets in COVID-19 patients in hospital stay days, ICU admission and mortality rate thereof: An open-label, single-blind randomized clinical trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Mojtaba Varshochi ◽  
Mohammad Shahi ◽  
Maryam Rahimzadeh ◽  
Hasan Amini ◽  
Ramin Mohammadzadeh

Background: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the super-spreading virus, has claimed hundreds of thousands of lives worldwide. Objectives: This study aimed to evaluate the effectiveness of the novel suggested herbal compound, formulated as compressed tablets, in reducing the length of hospital stay (LoS), intensive care unit (ICU) admission, and mortality in confirmed COVID-19 cases. Methods: Following an open-label, single-blind randomized clinical trial design, a total of 200 patients aged 18-65 admitted to Imam Reza hospital in Tabriz, northwest of Iran, were randomized to intervention and control groups in a 1:1 ratio, i.e., 100 subjects in each group. The former received standard treatment along with the compressed herbal tablets, and the latter only received the standard treatment. Adverse reactions incidence within 180 days after the beginning of the intervention was set as the primary safety endpoint. The most important and active ingredients of the tablets were Terminalia chebula, Glycyrrhiza glabra, Anacyclus pyrethrum, Senna alexandrina, Ferrula asafoetida, Pistacia lentiscus, Zizyphus jujuba, Crocus sativus, Echinacea angustifolia, and Hyssopus officinalis. This trial is registered at the Iranian Registry of Clinical Trials (code: IRCT20200522047545N1). Results: Those in the intervention arm had significantly lower rates of LoS (7.38 vs. 9.45, P = 0.030), ICU admission (6 out of 100 vs. 32 out of 100, P = 0.000), and mortality (1 vs. 19 out of 100, P = 0.000). Conclusions: Our observations suggest that adequate improvement is provided by the prepared herbal compound along with substantial savings in hospitalization hoteling costs. While further multi-center studies with a larger sample size are needed to extend our knowledge regarding the effect of this new option, these novel clinical data may well provide a new alternative for the management of COVID-19 disease.

Neurosurgery ◽  
2011 ◽  
Vol 68 (3) ◽  
pp. 622-631 ◽  
Author(s):  
Zoher Ghogawala ◽  
Brook Martin ◽  
Edward C. Benzel ◽  
James Dziura ◽  
Subu N. Magge ◽  
...  

Abstract BACKGROUND: Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction. OBJECTIVE: To determine the feasibility of a randomized clinical trial comparing the clinical effectiveness and costs of ventral vs dorsal decompression with fusion surgery for treating CSM. METHODS: A nonrandomized, prospective, clinical pilot trial was conducted. Patients ages 40 to 85 years with degenerative CSM were enrolled at 7 sites over 2 years (2007–2009). Outcome assessments were obtained preoperatively and at 3 months, 6 months, and 1 year postoperatively. A hospital-based economic analysis used costs derived from hospital charges and Medicare cost-to-charge ratios. RESULTS: The pilot study enrolled 50 patients. Twenty-eight were treated with ventral fusion surgery and 22 with dorsal fusion surgery. The average age was 61.6 years. Baseline demographics and health-related quality of life (HR-QOL) scores were comparable between groups; however, dorsal surgery patients had significantly more severe myelopathy (P < .01). Comprehensive 1-year follow-up was obtained in 46 of 50 patients (92%). Greater HR-QOL improvement (Short-Form 36 Physical Component Summary) was observed after ventral surgery (P = .05). The complication rate (16.6% overall) was comparable between groups. Significant improvement in the modified Japanese Orthopedic Association scale score was observed in both groups (P < .01). Dorsal fusion surgery had significantly greater mean hospital costs ($29 465 vs $19 245; P < .01) and longer average length of hospital stay (4.0 vs 2.6 days; P < .01) compared with ventral fusion surgery. CONCLUSION: Surgery for treating CSM was followed by significant improvement in disease-specific symptoms and in HR-QOL. Greater improvement in HR-QOL was observed after ventral surgery. Dorsal fusion surgery was associated with longer length of hospital stay and higher hospital costs. The pilot study demonstrated feasibility for a larger randomized clinical trial.


2017 ◽  
Vol 43 (2) ◽  
pp. 134-139 ◽  
Author(s):  
Aline dos Santos Machado ◽  
Ruy Camargo Pires-Neto ◽  
Maurício Tatsch Ximenes Carvalho ◽  
Janice Cristina Soares ◽  
Dannuey Machado Cardoso ◽  
...  

ABSTRACT Objective: To evaluate the effects that passive cycling exercise, in combination with conventional physical therapy, have on peripheral muscle strength, duration of mechanical ventilation, and length of hospital stay in critically ill patients admitted to the ICU of a tertiary care university hospital. Methods: This was a randomized clinical trial involving 38 patients (≥ 18 years of age) on mechanical ventilation who were randomly divided into two groups: control (n = 16), receiving conventional physical therapy; and intervention (n = 22), receiving conventional physical therapy and engaging in passive cycling exercise five days per week. The mean age of the patients was 46.42 ± 16.25 years, and 23 were male. The outcomes studied were peripheral muscle strength, as measured by the Medical Research Council scale, duration of mechanical ventilation, and length of hospital stay. Results: There was a significant increase in peripheral muscle strength (baseline vs. final) in both groups (control: 40.81 ± 7.68 vs. 45.00 ± 6.89; and intervention: 38.73 ± 11.11 vs. 47.18 ± 8.75; p < 0.001 for both). However, the range of increase in strength was higher in the intervention group than in the control group (8.45 ± 5.20 vs. 4.18 ± 2.63; p = 0.005). There were no significant differences between the groups in terms of duration of mechanical ventilation or length of hospital stay. Conclusions: The results suggest that the performance of continuous passive mobilization on a cyclical basis helps to recover peripheral muscle strength in ICU patients. (ClinicalTrials.gov Identifier: NCT01769846 [http://www.clinicaltrials.gov/])


Author(s):  
Fatemeh Moradiha ◽  
Sahar Farahmandrad ◽  
Hamideh Gholami

Objective: Nausea and vomiting are the most common complications and the first cause of hospitalization of pregnant women in the first trimester of pregnancy. Given the maternal and fetal complications as well as the negative psychosocial and economic effects of nausea and vomiting, the present study aimed to compare the antiemetic effects of ondansetron and metoclopramide. Methods: The present double-blind randomized clinical trial study was conducted on 153 pregnant women with a complaint of nausea and vomiting during pregnancy referred to the obstetrics and gynecology ward. Patients were randomly divided into two metoclopramide and ondansetron groups. The outcomes of interest were nausea and vomiting, the number of used doses of the drug, and the length of hospital stay. The Pregnancy-Unique Quantification of Emesis (PUQE) questionnaire was used to assess the severity of nausea and vomiting. Results: The mean age was significantly higher in the metoclopramide group (28.44±6.45 vs. 25.43±5.42 years, P=0.004). On day 3, the PUQE score was significantly higher in the ondansetron group (6.60±1.10 vs. 6.56±0.88, P<0.001). The decrease in the severity of nausea and vomiting was significantly higher in the ondansetron group (5.29±1.35 vs. 4.90±1.17, P=0.05) in the second day compared to the first day. In the repeated measure analysis, significant differences were found between the two treatment groups (F=7.01, P=0.009). There was no significant difference between the two groups in terms of the length of hospital stay (P>0.05). Conclusion: In this study, ondansetron revealed more efficacy than metoclopramide on the nausea and vomiting of pregnancy (NVP) management. Ondansetron may, therefore, be considered as a safe and effective alternative for metoclopramide in the treatment of NVP.


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