A Randomized, Double-Blind, Parallel-Group, Fixed-Dose, Clinical Trial of Quetiapine at 600 Versus 1200 mg/d for Patients With Treatment-Resistant Schizophrenia or Schizoaffective Disorder

2011 ◽  
Vol 31 (2) ◽  
pp. 160-168 ◽  
Author(s):  
Jean-Pierre Lindenmayer ◽  
Leslie Citrome ◽  
Anzalee Khan ◽  
Sashank Kaushik ◽  
Saurabh Kaushik
Keyword(s):  
Clinical Trial ◽  
Schizoaffective Disorder ◽  
Fixed Dose ◽  
Treatment Resistant ◽  
Double Blind ◽  
Parallel Group

scholarly journals The Acute Hemodynamic Effects of Caffeine During Different Body Positions in Normotensive Young Adults

2020 ◽  
Vol 71 (1) ◽  
pp. 133-139
Author(s):  
Elena Ioana Iconaru ◽  
Monica Marilena Tantu ◽  
Mariana Ionela Tudor ◽  
Manuela Mihaela Ciucurel ◽  
Luminita Georgescu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Young Adults ◽  
Experimental Design ◽  
Statistical Processing ◽  
Fixed Dose ◽  
Controlled Clinical Trial ◽  
Single Center ◽  
Hemodynamic Effects ◽  
Double Blind ◽  
Parallel Group

The aim of this study was to investigate the acute cardiovascular hemodynamic effects of administration of a fixed dose of 130 mg of caffeine versus placebo in a sample of healthy young adults (N = 32, sex ratio 1/1), who were successively placed in four distinct positions (orthostatic before ingestion, orthostatic, supine and Trendelenburg vertical positions, after ingestion) on a gravitational inversion table. The experimental design was a single-center, parallel-group, double-blind, randomized, placebo-controlled clinical trial. Following the descriptive and inferential statistical processing of the data, a statistical significant pattern (p [0.05) of acute postural cardiovascular hemodynamic adaptation of the subjects was revealed, under the influence of caffeine versus placebo ingestion.

scholarly journals Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Clinical Trial ◽  
Sore Throat ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020

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