Efficacy of nefazodone in the treatment of neuroleptic induced extrapyramidal side effects: a double-blind randomised parallel group placebo-controlled trial

2003 ◽  
Vol 18 (4) ◽  
pp. 271-275 ◽  
Author(s):  
Dora Wynchank ◽  
Michael Berk
Keyword(s):  
Side Effects ◽  
Controlled Trial ◽  
Extrapyramidal Side Effects ◽  
Double Blind ◽  
Parallel Group

High Dosage Haloperidol in Chronic Schizophrenia

1977 ◽  
Vol 131 (3) ◽  
pp. 310-316 ◽  
Author(s):  
Robin G. McCreadie ◽  
Ian M. MacDonald
Keyword(s):  
Alkaline Phosphatase ◽  
Side Effects ◽  
Serum Alkaline Phosphatase ◽  
Controlled Trial ◽  
Chronic Schizophrenia ◽  
Drug Resistant ◽  
Extrapyramidal Side Effects ◽  
Double Blind ◽  
High Doses

In a double blind chlorpromazine-controlled trial, high dosage haloperidol (100 mg daily) given for three months, appreciably improved the mental state of male chronic ‘drug resistant’ schizophrenic in-patients in the rehabilitation/long-stay unit of one psychiatric hospital. The results of a three-month follow-up suggested that the improvement could be maintained in some patients on lower doses of the drug.Serious extrapyramidal side effects were not seen at high doses. However, the majority of patients on haloperidol showed a deterioration in ward behaviour, possibly related to drowsiness, and developed raised serum alkaline phosphatase levels. These side effects disappeared in the follow-up period when either the drug was discontinued or the dose of haloperidol reduced.

Baclofen versus clonidine in the treatment of opiates withdrawal, side-effects aspect: a double-blind randomized controlled trial

2001 ◽  
Vol 26 (1) ◽  
pp. 67-71 ◽  
Author(s):  
S. A. Ahmadi-Abhari ◽  
S. Akhondzadeh ◽  
S. M. Assadi ◽  
O. L. Shabestari ◽  
Z. M. Farzanehgan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Controlled Trial ◽  
Double Blind ◽  
Randomized Controlled

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

A Double-Blind Comparative Clinical Trial of Floctafenine and Four Other Analgesics Conducted in General Practice

1976 ◽  
Vol 4 (3) ◽  
pp. 179-182 ◽  
Author(s):  
D M Lomas ◽  
J Gay ◽  
R N Midha ◽  
D L Postlethwaite
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Analgesic Effect ◽  
Rank Order ◽  
Controlled Trial ◽  
The Other ◽  
Double Blind ◽  
Comparative Clinical Trial

Three hundred and twelve patients suffering from painful conditions were admitted to a multicentre, double-blind controlled trial, conducted in general practice in which five analgesics—floctafenine (Idarac), paracetamol, aspirin, dihydrocodeine and pentazocine—were compared. Overall ratings of analgesic effect placed floctafenine first in rank order. Floctafenine was statistically significantly superior in effect to pentazocine but not to the other three agents as far as doctor ratings were concerned; and superior to both pentazocine and dihydrocodeine in the opinion of patients. Fewer patients experienced side-effects on floctafenine than on the other four analgesics and this difference between floctafenine and pentazocine, and floctafenine and dihydrocodeine was statistically significant.

scholarly journals Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024065 ◽  
Author(s):  
Henrik Gudbergsen ◽  
Marius Henriksen ◽  
Eva Ejlersen Wæhrens ◽  
Anders Overgaard ◽  
Henning Bliddal ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Single Centre ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
Parallel Group ◽  
Pain Subscale

IntroductionWith an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.Methods and analysis150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week −8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.Ethics and disseminationThe trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numbers2015-005163-16,NCT02905864, U1111-1171-4970Based on protocol versionV.6; 30 January 2017, 15:30 hours

Efficacy and safety of HX 110-A and HX 110-B in promoting respiratory health: An 8-week, randomized, double-blind, parallel group, placebo-controlled trial

2020 ◽  
Author(s):  
Jung-Kyu Lee ◽  
Bumjo Oh ◽  
Seo-Young Yoon ◽  
Tae Yun Park ◽  
Eun Young Heo ◽  
...  
Keyword(s):  
Lung Function ◽  
Respiratory Disease ◽  
Respiratory Symptoms ◽  
Respiratory Health ◽  
Controlled Trial ◽  
Clinical Pathology ◽  
Double Blind ◽  
Parallel Group ◽  
Anti Inflammatory ◽  
Experimental Group

Abstract Background HX110-A and HX110-B are compound extracts based on radix adenophorae and rhizoma dioscoreae, respectively, which have anti-inflammatory activity. There are limited data on whether they may help improve respiratory conditions including lung function. Therefore, in this trial, we will evaluate the effectiveness and safety of the use of HX110-A and HX110-B for the treatment of respiratory health in adults with mild respiratory symptoms. Methods/design This will be an 8-week, randomized, double-blind, parallel group, placebo-controlled trial with three arms. Adults more than 40 years old with persistent respiratory symptoms will be enrolled. Patients with definite respiratory disease or with a history of recent intake of antioxidants or anti-inflammatory agents will be excluded. Study subjects will be assigned at a 1:1:1 ratio into the following three arms: controls, experimental group 1 (HX110-A), and experimental group 2 (HX110-B). Control or experimental foods will be administered for 8 weeks, and follow-up will be up to 12 weeks. The primary outcome will be total antioxidant capacity. Secondary outcomes will be inflammatory indexes, respiratory symptoms, lung function, quality of life, and fatigue level. Safety outcomes will be assessed by monitoring adverse events and vital signs, and through clinical pathology tests. Conclusion We hope that this trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms. The results should clarify if active intake of specific foods with these functional compounds may promote respiratory health in adults without definite respiratory disease.

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