scholarly journals Efficacy and safety of dual intravenous artesunate plus quinine compared to intravenous artesunate for cerebral malaria in a triple blinded parallel multisite randomized controlled trial in Nigerian children: DUAL PAQ TRIAL Protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Michael Abel Alao ◽  
Adebola Emmanuel Orimadegun ◽  
Olayinka Rasheed Ibrahim ◽  
Abayomi O. Oyenuga ◽  
Adanze Onyenonachi Asinobi ◽  
...  

Abstract Background Evidence exists as to the criticality of the first 24 h in the management of cerebral malaria. The morbidity and the mortality rate (35%) with the current intravenous monotherapy for the initial treatment of cerebral malaria are unacceptably high. Combination therapy and a shorter course of effective medication have been shown to improve outcomes in human participants in the treatment of other diseases. This study outlines a protocol to conduct a triple blinded parallel randomized controlled trial on cerebral malaria using dual intravenous medications compared to the current standard of monotherapy. Methods This is a parallel multi-site randomized controlled superiority triple blinded trial consisting of intravenous artesunate plus quinine and a control arm of intravenous artesunate only. Eligible and assenting children aged 6 months to 17 years will be recruited from 4 tertiary hospitals by random selection from the list of tertiary hospitals in Nigeria. Participants will be randomized and assigned in parallel into two arms using random numbers generated from GraphPad Prism (version 9) by a clinical pharmacologist who has no link with the investigators, the patients, or the statistician. The primary measurable outcome is survival at 12, 24, and 48 h post-randomization. A composite secondary outcome consists of the number of children that regained consciousness, parasitaemia and defervescence at 12 and 24 h post-randomization and haematological and inflammatory markers at 24 and 48 h post-randomization. Adverse events both solicited and unsolicited are recorded all through the study post-randomization. The study is approved by the State Research Ethics Review Committee. Data analysis will be performed in GraphPad Prism version 9. Discussion The outcome of this analysis will give insight into the efficacy and safety of dual intravenous antimalaria in the treatment of cerebral malaria among Nigerian children compared with the standard of care. The safety profile of this intervention will also be highlighted. This may help inform physicians on the optimal treatment for cerebral malaria to improve outcomes and reduce recrudescence and treatment failure. Trial registration Pan Africa Clinical Trial Registry PACTR202102893629864. 23/02/2021.

2019 ◽  
Author(s):  
Qing Zhou ◽  
Shuo-yang Shi ◽  
Ben-sheng Wu ◽  
Cheng-biao Xu ◽  
Ji Geng ◽  
...  

Abstract Background: Hemorrhoidal disease (HD) is one of the commonest proctologic condition in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang-Xue-Di-Huang Decoction, a kind of ancient Chinese classical prescription, has been used to treat HD from the 19th century in China. However, clinical research of Liang-Xue-Di-Huang Decoction in the treatment of HD is lack. We designed this study to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in the treatment of HD. Methods/Design: A randomized, controlled, double blind, double-mimetic agent and multicenter trial to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction is proposed. HD patients (stage I, Ⅱ, Ⅲ) will be randomly assigned into Liang-Xue-Di-Huang Decoction with the addition of Diosmine mimetic agent group and Diosmine with the addition of Liang-Xue-Di-Huang Decoction mimetic agent group. Patients will receive a 7-day treatments and a 7-day follow-up. The primary outcome measure is the French Bleeding Score in 7 and 14 days. The Secondary outcome measures are Goligher Prolapse Score and Quality-of-Life Score in 7 and 14 days. Discussion: This study will provide objective evidence to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in treatment of HD. Trial registration: Chinese Clinical Trial Registry. ChiCTR-1900022531.Registered 19 Apr 2019, http://www.chictr.org.cn/listbycreater.aspx. Keywords: Hemorrhoidal disease, Liang-Xue-Di-Huang Decoction, Chinese classical prescription, Randomized controlled trial.


2021 ◽  
Author(s):  
Zhe Xue ◽  
Zhen Huang ◽  
Shu-li Cheng ◽  
Xi-hong Wang ◽  
Xuan Zhou ◽  
...  

Abstract Background: Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of great significance in the prevention and treatment of depression. Xiaoyao pills has achieved good results in clinical application, which has the advantages of quick effect and no obvious adverse reactions. The aim of our study is to evaluate the efficacy and safety of Xiaoyao pills on mild to moderate depression patients with syndrome of liver stagnation and spleen deficiency.Methods: This study is a multi-center, double-blinded, randomized and placebo-controlled clinical trial. A total of 108 participants will be assigned to three groups: Xiaoyao pill group taking Xiaoyao pills twice daily for 4 weeks, placebo group taking placebos twice daily for 4 weeks and normal group without taking any drug. The primary and secondary outcome measures are the Hamilton Depression Scale (HAMD) and Traditional Chinese Medicine (TCM) Syndrome Scale. The assessment is at baseline(before treatment initiation), 1 week, 2 weeks 4 weeks after the first treatment. Exploratory outcome is also assessed to explore the mechanism of Xiaoyao pills at baseline and 4 weeks.Discussion: The results from this study will provide clinical evidence on the efficacy and safety of Xiaoyao pills in patients with mild to moderate depression with syndrome of liver stagnation and spleen deficiency.Trial registration: International Standard Randomized Controlled Trial Number Register: ISRCTN12746343. Registered on September 25, 2020.


2020 ◽  
Author(s):  
Yafan Bai ◽  
Chao Gao ◽  
Wenjing Li ◽  
Yi Du ◽  
Lixin An

Abstract Background : Postoperative gastrointestinal (GI) dysfunction (PGD) is a common problem after abdominal surgery. PGD can increase the length of hospital stay and the economic burden and may even lead to some serious complications. Acupuncture and moxibustion are alternative therapies recommended for PGD. However, the effect of preventive application of acupuncture or transcutaneous electrical acupuncture stimulation (TEAS) is still uncertain. The purpose of this study is to investigate the efficacy of the continuous application of TEAS on GI function recovery in patients after abdominal surgery. At the same time, we will try to confirm the mechanism of TEAS through the brain-gut axis.Methods/design : This study is a prospective, single-center, two-arm, randomized controlled trial that will be performed in a general hospital. In total, 280 patients scheduled for gastric or colorectal cancer surgery will be stratified into two groups. The experimental group will receive TEAS stimulation at Hegu (L14) and Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37) once a day for 30 min during and after surgery until GI function recovery. The sham group will receive pseudo-TEAS at sham acupoints. The primary outcome will be the recovery time of postoperative bowel sounds, flatus, bowel movements and the changes in perioperative brain-intestinal peptides. The secondary outcome will be postoperative pain, perioperative complications, and hospitalization duration.Discussion : The results of this study will demonstrate that continuous preventive application of TEAS can improve the GI function recovery in patients undergoing abdominal surgery and that this effect may act through brain-gut peptides.Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1900023263, Registered on 11 May 2019,http://www.chictr.org.cn


2021 ◽  
Author(s):  
Michael Abel Alao ◽  
Adebola Emmanuel Orimadegun ◽  
Olayinka Rasheed Ibrahim ◽  
Abayomi O Oyenuga ◽  
Adanze Onyenonachi Asinobi ◽  
...  

Abstract Background: Evidence exists as to the criticality of the first 24 hours in the management of cerebral malaria. This could serve as a potential safety net for improved outcomes with prompt treatment and utilization of effective therapy. The morbidity and the mortality rate (35%) with the current parenteral monotherapy for the initial treatment of cerebral malaria is unacceptably high. Combination therapy and a shorter course of effective medication have been shown to improve outcomes in human subjects in treatment of other diseases. This study outlines a protocol to conduct a triple blinded randomized control trial on cerebral malaria using dual parenteral medications compared to the current standard of monotherapy.Methods: This is a randomized control triple blinded trial consisting of an intervention and 2 control arms. Eligible and assenting children aged 6 months to 17 years will be recruited from 4 tertiary hospitals by random selection from the list of tertiary hospitals in Nigeria. Subjects will be concealed and allocated in parallel into three arms using random numbers generated from GraphPad Prism (version 9) by a Clinical Pharmacologist who has no link with the investigators, the patients, or the statistician. The parasite load and clearance, fever defervesence, C reactive protein, procalcitonin, blood glucose, electrocardiograms and time to regain consciousness will be monitored. The socio-demographic and clinical details of all patients will be documented. The study will be conducted in line with Declaration of Hesinki 2013. Appropriate statistical tools will be used for data collection and analysis.Discussion:The outcome of this analysis will give insight into the efficacy of dual parenteral antimalaria in the treatment of cerebral malaria among Nigerian children compared with standard of care. The safety profile of this intervention would also be highlighted. This may help inform Physicians on the optimal treatment for cerebral malaria to improve outcomes, prevent development of resistance, recrudescence, treatment failure and stimulate interest of pharmaceutical companies in the development of newer formulations of dual parenteral antimalarial combination therapies. Trial registration: This study was registered in the Pan Africa Clinical Trial Registry (PACTR202102893629864).


2020 ◽  
Author(s):  
qing zhou ◽  
Shuo-yang Shi ◽  
Zong-qi He ◽  
Cheng-biao Xu ◽  
Ji Geng ◽  
...  

Abstract Background: Hemorrhoidal disease (HD) is one of the commonest proctologic condition in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang-Xue-Di-Huang Decoction, a kind of ancient Chinese classical prescription, has been used to treat HD from the 19th century in China. However, clinical research of Liang-Xue-Di-Huang Decoction in the treatment of HD is lack. We designed this study to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in the treatment of HD. Methods/Design: A randomized, controlled, double blind, double-mimetic agent and multicenter trial to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction is proposed. HD patients (stage I, Ⅱ, Ⅲ) will be randomly assigned into Liang-Xue-Di-Huang Decoction with the addition of Diosmine mimetic agent, or Diosmine with the addition of Liang-Xue-Di-Huang Decoction mimetic agent. Patients will receive a 7-days treatments and a 7-days follow-up. The primary outcome measure is the French Bleeding Score in 7 and 14 days. The Secondary outcome measures are Goligher Prolapse Score and Quality-of-Life Score in 7 and 14 days. Discussion: This study will provide objective evidence to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in treatment of HD. Trial registration: Chinese Clinical Trial Registry. ChiCTR-1900022531.Registered 15 Apr 2019, http://www.chictr.org.cn/listbycreater.aspx.


2019 ◽  
Author(s):  
Qing Zhou ◽  
Shuo-yang Shi ◽  
Zong-qi He ◽  
Cheng-biao Xu ◽  
Ji Geng ◽  
...  

Abstract Abstract Background: Hemorrhoidal disease (HD) is one of the commonest proctologic condition in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang-Xue-Di-Huang Decoction, a kind of ancient Chinese classical prescription, has been used to treat HD from the 19th century in China. However, clinical research of Liang-Xue-Di-Huang Decoction in the treatment of HD is lack. We designed this study to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in the treatment of HD. Methods/Design: A randomized, controlled, double blind, double-mimetic agent and multicenter trial to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction is proposed. HD patients (stage I, Ⅱ, Ⅲ) will be randomly assigned into Liang-Xue-Di-Huang Decoction with the addition of Diosmine mimetic agent group and Diosmine with the addition of Liang-Xue-Di-Huang Decoction mimetic agent group. Patients will receive a 7-day treatments and a 7-day follow-up. The primary outcome measure is the French Bleeding Score in 7 and 14 days. The Secondary outcome measures are Goligher Prolapse Score and Quality-of-Life Score in 7 and 14 days. Discussion: This study will provide objective evidence to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in treatment of HD. Trial registration: Chinese Clinical Trial Registry. ChiCTR-1900022531.Registered 15 Apr 2019, http://www.chictr.org.cn/listbycreater.aspx.


2021 ◽  
Vol 12 ◽  
Author(s):  
Hui Qi ◽  
Yue-E Wu ◽  
Ya-Li Liu ◽  
Chen Kou ◽  
Ze-Ming Wang ◽  
...  

Early-onset neonatal sepsis (EONS), a bacterial infection that occurs within 72 h after birth, is associated with high likelihood of neonatal mortality. Latamoxef, a semi-synthetic oxacephem antibiotic developed in 1980s, has been brought back into empirical EONS treatment in recent years. In the preliminary work, we established a population pharmacokinetics (PPK) model for latamoxef in Chinese neonates. Moreover, in order to better guide clinical treatment, we conducted dose simulation and found that ascending administration frequency could improve the target rate of 70% of patients having a free antimicrobial drug concentration exceeding the MIC during 70% of the dosing interval (70% fT > MIC). Accordingly, this study is aimed to compare the 70% fT > MIC, efficacy and safety between conventional regimen and PPK model regimen for rational use of latamoxef in EONS treatment. A single-blind, multicenter randomized controlled trial (RCT) for latamoxef will be conducted in Chinese EONS patients. Neonates (≤3 days of age, expected number = 114) admitted to the hospital with the diagnosis of EONS and fulfilling inclusion and exclusion criteria will be randomized (ratio of 1:1) to either a conventional regimen (30 mg/kg q12h) or model regimen (20 mg/kg q8h) latamoxef treatment group for at least 3 days. Primary outcome measure will be 70% fT > MIC and secondary outcome indicators will be the latamoxef treatment failure, duration of antibiotic therapy, changes of white blood cell count (WBC), C-reactive protein (CRP) and procalcitonin (PCT), blood culture results during administration and incidence of adverse event (AE)s. Assessments will be made at baseline, initial stage of latamoxef treatment (18–72 h) and before the end of latamoxef treatment. Ethical approval of our clinical trial has been granted by the ethics committee of the Beijing Children’s Hospital (ID: 2020-13-1). Written informed consent will be obtained from the parents of the participants. This trial is registered in the Chinese Clinical Trial Registry (ChiCTR 2000040064).It is hoped that our study will provide a clinical basis for the rational clinical use of latamoxef in EONS treatment.


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