Neutral Electrolyzed Water (SES) for Nasopharyngeal and Oropharyngeal Rinses Prevented COVID-19 in Front-Line Health Professionals: A Randomized, Open-Label, Controlled Trial in a General Hospital in Mexico City.

Abstract Background: The COVID-19 pandemic, caused by the SARS-COV-2 virus, has destabilized society all around the world and is predicted to take a long time to be overcome. The worldwide efforts that healthcare professionals are making is well known, and the high risk of illness and death that front-line staff experience on a daily basis is a reality as well. Despite well-defined protocols for the use of personal protective equipment, many nurses and doctors are still getting sick and dying. It is well known that vaccination is still faraway to be achieved worldwide and that new variants are emerging, so additional protective measures must be explored. This study investigated the effectivity of a neutral electrolyzed water (SES) to reduce the risk of COVID-19 disease in front-line medical staff, when it was used for nasopharyngeal and oropharyngeal rinses (prophylactic protocol).Methods: A prospective open-label, randomized controlled clinical trial was performed in front-line medical staff from the general hospital Enrique Cabrera in México City. One hundred and seventy volunteers were enrolled and equally divided in control group and SES group. All members of the trial wore the adequate personal protection equipment at all times while performing their duties, as required by standard COVID-19 safety protocols. Additionally, the SES group participants followed a prophylactic protocol with SES (oral and nasal rinses, three times a day for 4 weeks). All participants were monitored for COVID-19 symptoms and disease in a time-frame of 4 weeks and the incidence of illness per group was registered. The relative risk of disease, associated with each treatment was calculated. Results: The presence of COVID-19 positive cases, in the group that received the nasal and oral rinses with SES was 1.2%, while in the group that did not do the SES rinses (control group), it was 12.7% (p= 0.0039 and RR= 0.09405; 95%, CI of 0.01231-0.7183). The prophylactic protocol was demonstrated as a protective factor for developing the disease. Conclusions: Nasal and oral rinses with SES may be an efficient alternative to reinforce the protective measures against COVID-19 disease and should be further investigated. Trial registration: RPCEC00000357. Retrospectively registered, March, 16, 2021. https://rpcec.sld.cu/en/trials/RPCEC00000357-En/revisions/5137/view

Download Full-text

Nasopharyngeal and oropharyngeal rinses with neutral electrolyzed water prevents COVID‑19 in front‑line health professionals: A randomized, open‑label, controlled trial in a general hospital in Mexico City

Biomedical Reports ◽

10.3892/br.2021.1494 ◽

2021 ◽

Vol 16 (2) ◽

Author(s):

Rafael Gutiérrez‑García ◽

Juan C. De La Cerda‑Angeles ◽

Ariana Cabrera‑Licona ◽

Ivan Delgado‑Enciso ◽

Nicolas Mervitch‑Sigal ◽

...

Keyword(s):

General Hospital ◽

Mexico City ◽

Health Professionals ◽

Controlled Trial ◽

Front Line ◽

Open Label ◽

Electrolyzed Water

Download Full-text

Outcome of lymph node tuberculosis management with conventional treatment with and without prednisolone

Tropical Doctor ◽

10.1177/0049475520984745 ◽

2021 ◽

pp. 004947552098474

Author(s):

Arjuman Sharmin ◽

Ali Hossain ◽

Nazmul Islam ◽

Zakir H Sarker ◽

Sheikh S Hossain ◽

...

Keyword(s):

Clinical Trial ◽

Lymph Node ◽

Complete Resolution ◽

Conventional Treatment ◽

Symptomatic Improvement ◽

Control Group ◽

Controlled Clinical Trial ◽

Open Label ◽

Lymph Node Tuberculosis ◽

And Control

The outcome of lymph node tuberculosis (LNTB) management with conventional anti-tubercular treatment alone is unsatisfactory. We conducted a randomised open-label controlled clinical trial in the Department of Respiratory Medicine in Government Institute of Dhaka, Bangladesh from April 2017 to March 2019. Compared with controls, 54 patients of LNTB received category 1 anti-tubercular treatment with additional prednisolone after randomisation. Complete resolution in 21/54 (75%) and 7 (26.9%), symptomatic improvement in 26 (92.9%) and 22 (84.6%) and complications in 11 (39.28%) and 16 (61.53%) were observed in the treatment and control group, respectively. Thus, we recommend the use of steroids in this setting.

Download Full-text

Early Use of Sarilumab in Patients Hospitalised with COVID-19 Pneumonia and Features of Systemic Inflammation.

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.02107-21 ◽

2021 ◽

Author(s):

Nicolás Merchante ◽

Sheila Cárcel ◽

José Carlos Garrido-Gracia ◽

Marta Trigo-Rodríguez ◽

María Ángeles Esteban Moreno ◽

...

Keyword(s):

Mechanical Ventilation ◽

Systemic Inflammation ◽

Primary Outcome ◽

Invasive Mechanical Ventilation ◽

Control Group ◽

Controlled Clinical Trial ◽

Open Label ◽

Randomized Controlled ◽

Subcutaneous Dose ◽

Early Use

In this phase II, open-label, randomized, controlled clinical trial of 115 patients hospitalized with COVID-19 and systemic inflammation, early use of sarilumab was associated with a low risk of acute respiratory distress syndrome requiring high-flow devices or mechanical ventilation. Objective: To investigate the efficacy and safety of early treatment with sarilumab, added to standard of care (SOC), in hospitalised adults with COVID-19. Methods: Phase II, open-label, randomized, controlled clinical trial of hospitalised patients with COVID-19 pneumonia and interleukin (IL)-6 levels ≥ 40 pg/mL and/or D-dimer > 1500 ng/mL. Participants were randomized (1:1:1) to receive SOC (control group), SOC plus a single subcutaneous dose of sarilumab 200 mg (Sarilumab-200) or SOC plus a single subcutaneous dose of sarilumab 400 mg (Sarilumab-400). The primary outcome variable was the development of acute respiratory distress syndrome (ARDS) requiring high-flow nasal oxygenation (HFNO), non-invasive mechanical ventilation (NIMV) or invasive mechanical ventilation (IMV) at day 28. Results: One-hundred and fifteen participants (control group, n = 39; Sarilumab-200, n = 37; Sarilumab-400, n = 39) were included. At randomization, 104 (90%) patients had supplemental oxygen and 103 (90%) received corticosteroids. Eleven (28%) patients in the control group, ten (27%) in Sarilumab-200 and five (13%) in Sarilumab-400 developed the primary outcome (hazard ratio [95% CI] of Sarilumab-400 vs control group: 0.41 [0.14-1.18]; p=0.09). Seven (6%) patients died: three in the control group and four in Sarilumab-200. There were no deaths in Sarilumab-400 (p = 0.079, log-rank test for comparisons with the control group). Conclusion: In patients recently hospitalised with COVID-19 pneumonia and features of systemic inflammation, early IL-6 blockade with a single dose of sarilumab 400 mg was safe and associated with a trend for better outcomes.

Download Full-text

Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2018/9329465 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8

Author(s):

Yu-yang Pang ◽

Yan Li ◽

Gang Kui ◽

Yong Tang ◽

Ming-juan Liao ◽

...

Keyword(s):

Clinical Trial ◽

Myeloproliferative Neoplasms ◽

Controlled Trial ◽

Intervention Group ◽

Complete Healing ◽

Control Group ◽

Controlled Clinical Trial ◽

Leg Ulcers ◽

Open Label ◽

Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

Download Full-text

Baidu Jieduan granule, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial

10.21203/rs.3.rs-44542/v2 ◽

2020 ◽

Author(s):

Wen Zhang ◽

Qin Xie ◽

Xiaoming Xu ◽

Shuting Sun ◽

Tian Fan ◽

...

Keyword(s):

Clinical Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Controlled Trial ◽

Theory And Practice ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Open Label ◽

Randomized Controlled

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

Download Full-text

Diets enriched with whole grains reduce premenstrual syndrome scores in nurses: an open-label parallel randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114519000333 ◽

2019 ◽

Vol 121 (09) ◽

pp. 992-1001 ◽

Cited By ~ 1

Author(s):

Mozhgan Esmaeilpour ◽

Sedigheh Ghasemian ◽

Mohammad Alizadeh

Keyword(s):

Clinical Trial ◽

Premenstrual Syndrome ◽

Controlled Trial ◽

Intervention Group ◽

Whole Grains ◽

Control Group ◽

Controlled Clinical Trial ◽

Daily Consumption ◽

Open Label ◽

Refined Grains

AbstractAlthough previous studies have demonstrated the beneficial effects of some components of whole grains on premenstrual syndrome (PMS), our literature review shows that no clinical trial has studied the effect of whole grain consumption on PMS so far. Therefore, the present study was designed to study the effect of diets rich in whole grains on PMS among nurses. This study is a parallel controlled clinical trial with a 3-month intervention period in which, after following two menstrual cycles among nurses, 100 nurses diagnosed with PMS were randomly divided into two groups of intervention and control, with fifty individuals in each. Those in the intervention group replaced at least four servings of refined grains in their daily diets with whole grains. To supply four servings, 120 g of bread made with whole flour was given to the intervention group on a daily basis. Those in the control group, however, continued their regular daily consumption of grains. The two groups were compared regarding PMS symptoms after adjusting the confounding variables. The repeated measurement test showed that the interaction between the time factor and the experimental group on the mean score of PMS symptoms was significant. That is, the intervention group showed a significant decrease in the general, mood, physical and behavioural symptoms of PMS compared with the controls (P<0·001, P=0·01, P<0·001 and P=0·003, respectively). Therefore, daily consumption of whole grains in place of refined grains can contribute to improvement in PMS symptoms. Further studies are needed to confirm our findings.

Download Full-text

Whey Protein (Ma’aljobon) as a Complementary Therapy for Treatment of Attention-deficit/ Hyperactivity Disorder (ADHD): A Randomized Open-label Controlled Clinical Trial

Galen Medical Journal ◽

10.31661/gmj.v9i0.1690 ◽

2020 ◽

Vol 9 ◽

pp. 1690

Author(s):

Zeinab Mostajeran ◽

Seyed Hamdollah Mosavat ◽

Mostafa Najafi ◽

Majid Emtiazy ◽

Mohammad Hashem Hashempur

Keyword(s):

Clinical Trial ◽

Attention Deficit Hyperactivity Disorder ◽

Whey Protein ◽

Attention Deficit ◽

Performance Test ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Open Label ◽

Hyperactivity Disorder

Background: Attention deficit hyperactivity disorder (ADHD) is a common, chronic, neurodevelopmental disorder that manifests in childhood with symptoms of hyperactivity, inattention, and impulsivity. Ma’aljobon (a kind of whey protein) that is derived from milk during cheese producing process is a popular dietary traditional product supposed to provide immune modulation and prevent neuropsychiatric disorder. We aimed to evaluate the efficacy of ma’aljobon in management of Attention-deficit/hyperactivity disorder (ADHD). Materials and Methods: In this open-label randomized, double arm, and controlled clinical trial, sixty four patients with ADHD who referred to out-patient child and adolescent clinic of Khorshid Hospital of Isfahan, Iran, were randomly assigned in the intervention group (ma’aljobon 25 g once daily plus standard conventional treatment (SCT)) or control group (SCT only) for a period of 8 weeks. Scores of the Strengths and Difficulties Questionnaire (SDQ) and Conners’ Continuous Performance Test (CPT) were set as the outcome measures. Results: Parent reported hyperactivity scale of SDQ showed a significant decrease in the intervention group compared to the control group (P=0.04). However, no significant between groups differences were observed in other scales of parent-reported SDQ. Also, according to the results of CPT, there was a significant improvement in the intervention group regarding attention and focus score (P=0.01). Conclusion: Ma’aljobon might be considered as a complementary remedy for improving hyperactivity, attention and focus of children with ADHD. However, further researches with larger sample size and longer duration should be done for achieving more reliable results. [GMJ.2020;9:e1690]

Download Full-text

An open-label, randomized, controlled clinical trial to explore the curative effects between the treatment of capecitabine and andrographolide and the single capecitabine in the patients with pathological and/or histologic diagnosed unresectable, advanced, recurrent, and metastatic colorectal cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.4_suppl.tps819 ◽

2017 ◽

Vol 35 (4_suppl) ◽

pp. TPS819-TPS819 ◽

Cited By ~ 1

Author(s):

Yongqian Shu ◽

Jing Sun ◽

Peifen Cai ◽

Weicheng Wang ◽

Xiao Han ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Trial ◽

Target Therapy ◽

The Elderly ◽

Control Group ◽

Controlled Clinical Trial ◽

High Dose ◽

Randomized Controlled Clinical Trial ◽

Open Label ◽

Randomized Controlled

TPS819 Background: Colorectal cancer (CRC) is one of the most commonly diagnosed solid tumors worldwide. Current therapies for the treatment of CRC mainly comprise fluoropyromidine-based chemotherapies that are used individually or in combination with oxaliplatin or/with target therapy. Andrographolide, a natural diterpenoid from Andrographispaniculata, has been reported to exert antibacterial, antiviral, anti-inflammation and neuroprotectiveactivities. Our previous studies have proved that Andrographolide can inhibit tumor growth in mice at a relatively high dose(about 200 mg/kg).The aim of the study is to make a comparison of PFS, RR, and OS of the elderly CRC between the treatment of xeloda and andrographolide and the signal xeloda.We look forward to these findings highlight the potential possibility of using this natural, safe and relatively inexpensivecompound as potential adjunctive treatments in improving the overall treatment response of patients with CRC in future. Methods: This is an open-label, randomized, controlled clinical trial. Patients older than or equal to 65, by pathological and/or histologic diagnosed unresectable, advanced, recurrent andmetastatic CRC, will be enrolled. These patients’ tumors must be clearly measured by radiographic technology. All cases of chemotherapy patients randomly divided into two groups, experimental group (xeloda with andrographolide): xeloda: 1250mg/m2 , po bid, d1–14, q3w; andrographolide: 500mg, ivd qd, d1–14, q3w; control group (xeloda): 1250mg/m2, po bid, d1–14, q3w, 21d/cycle. After each 2 cycles, patients will be examined by imageological tests (CT and/or MRI) or tumour biomarkers (CEA and CA199) to estimate the curative effects. Until the tumor progression or after 6 cycles, patients will be removed from this study. PFS is set as the primary endpoint while secondary endpoints include overall survival (OS), overall response rate (ORR), and health-related quality of life (HRQoL). Recruitment has begun in Jan 2014 and about 52 patients has joined this study. Clinical trial information: NCT01993472.

Download Full-text

Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial

BMJ Open ◽

10.1136/bmjopen-2020-039951 ◽

2020 ◽

Vol 10 (11) ◽

pp. e039951

Author(s):

Rafael León López ◽

Sheila Cárcel Fernández ◽

Laura Limia Pérez ◽

Alberto Romero Palacios ◽

María Concepción Fernández-Roldán ◽

...

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Cytokine Release ◽

Cytokine Release Syndrome ◽

Open Label ◽

Early Administration ◽

Hospitalised Patients

IntroductionAbout 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inhibitor) in hospitalised patients with COVID-19, pulmonary infiltrates and a high IL-6 or D-dimer serum level could reduce the progression of ARDS requiring high-flow nasal oxygen or mechanical ventilation (non-invasive or invasive).Methods and analysisPhase II, open-label, randomised, multicentre, controlled clinical trial to study the efficacy and safety of the administration of two doses of sarilumab (200 and 400 mg) plus best available therapy (BAT) in hospitalised adults with COVID-19 presenting cytokine release syndrome. This strategy will be compared with a BAT control group. The efficacy and safety will be monitored up to 28 days postadministration. A total of 120 patients will be recruited (40 patients in each arm).Ethics and disseminationThe clinical trial has been approved by the Research Ethics Committee of the coordinating centre and authorised by the Spanish Agency of Medicines and Medical Products. If the hypothesis is verified, the dissemination of the results could change clinical practice by increasing early administration of sarilumab in adult patients with COVID-19 presenting cytokine release syndrome, thus reducing intensive care unit admissions.Trial registration numberNCT04357860.

Download Full-text

Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial

Journal of Antimicrobial Chemotherapy ◽

10.1093/jac/dkaa334 ◽

2020 ◽

Vol 75 (11) ◽

pp. 3379-3385 ◽

Cited By ~ 12

Author(s):

Anahita Sadeghi ◽

Ali Ali Asgari ◽

Alireza Norouzi ◽

Zahedin Kheiri ◽

Amir Anushirvani ◽

...

Keyword(s):

Standard Care ◽

Controlled Trial ◽

Standard Of Care ◽

Control Group ◽

Controlled Clinical Trial ◽

University Hospitals ◽

Open Label ◽

Serious Adverse Events ◽

Clinical Recovery ◽

Randomized Controlled

Abstract Background Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19. Methods This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2. Results Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4–8)] than the control group [8 days (IQR 5–13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray’s P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported. Conclusions The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.

Download Full-text