Anti-Inflammatory Effect of Crocus sativus on Serum Cytokine Levels in Subjects with Metabolic Syndrome: A Randomized, Double-Blind, Placebo- Controlled Trial

2018 ◽  
Vol 12 (2) ◽  
pp. 122-126 ◽  
Author(s):  
Tayebe Kermani ◽  
Maedeh Zebarjadi ◽  
Hassan Mehrad-Majd ◽  
Seyed-Reza Mirhafez ◽  
Maryam Shemshian ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Controlled Trial ◽  
Crocus Sativus ◽  
Serum Cytokine ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cytokine Levels ◽  
Anti Inflammatory ◽  
Inflammatory Effect

Frühgeborene unter maschineller Beatmung: Immunmodulatorischer Effekt der präventiven Gabe von Azithromycin

2020 ◽  
pp. 1-3
Author(s):  
Maximilian Jorczyk
Keyword(s):  
Very Low Birth Weight ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Double Blind ◽  
Mechanically Ventilated ◽  
Before And After ◽  
Anti Inflammatory ◽  
To Receive ◽  
Therapeutic Possibilities ◽  
Inflammatory Effect

<b>Introduction:</b> Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities. <b>Objective:</b> The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates. <b>Methods:</b> This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for <i>Ureaplasma</i>. Patients were followed up throughout the hospital stay for the outcomes of death and bronchopulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703). <b>Results:</b> Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O<sub>2</sub> dependency at 28 days/death in azithromycin-treated patients regardless of the detection of <i>Ureaplasma</i> in blood. <b>Conclusions:</b> Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O<sub>2</sub> dependency at 28 days/death in mechanically ventilated preterm neonates.

scholarly journals Morinda citrifolia(Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
H. M. Fletcher ◽  
J. Dawkins ◽  
C. Rattray ◽  
G. Wharfe ◽  
M. Reid ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Morinda Citrifolia ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Menstrual Cycles ◽  
Primary Dysmenorrhoea ◽  
Before And After ◽  
Laboratory Variables ◽  
Anti Inflammatory ◽  
Bleeding Score

Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea.Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume.Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls.Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo.

scholarly journals CASCADE: a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of tezepelumab on airway inflammation in patients with uncontrolled asthma

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Claire Emson ◽  
Sarah Diver ◽  
Latifa Chachi ◽  
Ayman Megally ◽  
Cherrie Small ◽  
...  
Keyword(s):  
Inflammatory Cells ◽  
Phase 2 ◽  
Uncontrolled Asthma ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Inflammatory Status ◽  
Parallel Group ◽  
Anti Inflammatory ◽  
The Impact ◽  
Inflammatory Effect

Abstract Background Patients with severe, uncontrolled asthma, particularly those with a non-eosinophilic phenotype, have a great unmet need for new treatments that act on a broad range of inflammatory pathways in the airway. Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin, an epithelial cytokine. In the PATHWAY phase 2b study (NCT02054130), tezepelumab reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma, irrespective of baseline eosinophilic inflammatory status. This article reports the design and objectives of the phase 2 CASCADE study. Methods CASCADE is an ongoing exploratory, phase 2, randomized, double-blind, placebo-controlled, parallel-group study aiming to assess the anti-inflammatory effects of tezepelumab 210 mg administered subcutaneously every 4 weeks for 28 weeks in adults aged 18–75 years with uncontrolled, moderate-to-severe asthma. The primary endpoint is the change from baseline to week 28 in airway submucosal inflammatory cells (eosinophils, neutrophils, T cells and mast cells) from bronchoscopic biopsies. Epithelial molecular phenotyping, comprising the three-gene-mean technique, will be used to assess participants’ type 2 (T2) status to enable evaluation of the anti-inflammatory effect of tezepelumab across the continuum of T2 activation. Other exploratory analyses include assessments of the impact of tezepelumab on airway remodelling, including reticular basement membrane thickening and airway epithelial integrity. At the onset of the COVID-19 pandemic, the protocol was amended to address the possibility that site visits would be limited. The amendment allowed for: at-home dosing of study drug by a healthcare professional, extension of the treatment period by up to 6 months so patients are able to attend an onsite visit to undergo the end-of-treatment bronchoscopy, and replacement of final follow-up visits with a virtual or telephone visit. Discussion CASCADE aims to determine the mechanisms by which tezepelumab improves clinical asthma outcomes by evaluating the effect of tezepelumab on airway inflammatory cells and remodelling in patients with moderate-to-severe, uncontrolled asthma. An important aspect of this study is the evaluation of the anti-inflammatory effect of tezepelumab across patients with differing levels of eosinophilic and T2 inflammation. Trial registration NCT03688074 (ClinicalTrials.gov). Registered 28 September 2018.

Late Phase Inflammation during Nasal Grass and Ragweed Challenge in a Double-Blind Placebo Controlled Trial with Astemizole

1995 ◽  
Vol 9 (3) ◽  
pp. 169-174 ◽  
Author(s):  
Marianne Frieri ◽  
James Madden ◽  
Myron Zitt ◽  
Nanjundaiah S. Kumar ◽  
Maria Knapik
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Interleukin 1 ◽  
Late Phase ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nasal Provocation ◽  
Anti Inflammatory

Allergic rhinitis is an IgE-mediated inflammatory reaction characterized by an early “classic” immediate hypersensitivity response and/or a subsequent late phase response. Nasal provocation to antigen challenge is a useful method of evaluating this dual response. Several H1 antagonists may exhibit antiinflammatory properties by diminishing histamine release or inhibiting eosinophil chemotaxis. To determine whether astemizole has any anti-inflammatory characteristics, we studied 20 patients with allergic rhinitis in a double-blind placebo-controlled fashion after a 4-week course of treatment with this H1 antagonist. Nasal provocation over 30 minutes was performed out of season using increasing concentrations of grass or ragweed extract from 10–1000 PNU. Patients were evaluated for their clinical response, and nasal lavage secretions were analyzed over 6 hours by ELISA for alpha interleukin-1, interleukin-8, albumin, and histamine levels. Total sneezing and other symptom scores for rhinorrhea, nasal congestion, and pruritus were decreased in astemizole-treated compared to placebo-treated patients both at 30 minutes (early phase), and at 3 and 6 hours (late phase) after nasal provocation. However, these results did not reach statistical significance. Nasal α IL-1 levels diminished from diluent control lavage to a significantly greater degree in astemizole than in placebo-treated patients (P < 0.05). This diminution in late phase α IL-1 suggests that astemizole may possess anti-inflammatory properties.

scholarly journals Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017652 ◽  
Author(s):  
Christelle Nguyen ◽  
Isabelle Boutron ◽  
Gabriel Baron ◽  
Emmanuel Coudeyre ◽  
Francis Berenbaum ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
The Mean ◽  
Anti Inflammatory

IntroductionOsteoarthritis (OA) pathophysiology is driven in part by joint inflammation. Resveratrol has in vitro anti-inflammatory properties. We aim to assess the efficacy of oral resveratrol for knee pain at 3 months in people with knee OA.Methods and analysisWe will conduct a randomised double-blind placebo-controlled trial. Overall, 164 individuals with knee OA fulfilling 1986 American College of Rheumatology criteria will be recruited in three tertiary care centres in France and randomised to receive oral resveratrol, 40 mg (two caplets) two times per day for 1 week, then 20 mg (one caplet) two times per day or a matching placebo for a total of 6 months. Randomisation will be centralised and stratified by centre. The allocation ratio of assignments will be 1:1. The primary outcome will be the mean change from baseline in knee pain on a self-administered 11-point pain Numeric Rating Scale at 3 months. Secondary outcomes will be the mean change in knee pain at 6 months, the function subscore of the Western Ontario and McMaster Universities Arthritis Index score, patient global assessment, proportion of responders according to the Osteoarthritis Research Society International–Outcome Measures in Rheumatology criteria at 3 and 6 months, and self-reported number of intra-articular injections of corticosteroids or hyaluronic acid and consumption of analgesics and non-steroidal anti-inflammatory drugs since the last contact. Other interventions will be allowed and self-reported. Adherence will be monitored by capsule counts and a booklet and adverse events recorded at 3 and 6 months. Statisticians, treating physicians and participants will be blinded to the allocated treatment.Ethics and disseminationThe oral resveratrol in knee osteoarthritis (ARTHROL) trial has been authorised by theAgenceNationale de Sécurité du Médicament et des Produits de Santéand ethics were approved by theComité deProtection des Personnes Île-de-FranceIII. The findings of the study will be published in a peer-reviewed journal and disseminated at conferences. The design of ARTHROL will warrant the translation of its findings into clinical practice.Trial registration numberClinicalTrials.gov identifier:NCT02905799. Pre-results. First received: 14 September 2016. Last updated: 16 September 2016. Status: not yet recruiting.

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