A double blind, randomised placebo controlled trial evaluating the effect of a pholyphenolic rich plant based nail bed balm on the severity of chemotherapy-induced onycholysis.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10103-10103
Author(s):  
Robert J. Thomas ◽  
Madeleine M A Williams ◽  
Masoom Mutilib ◽  
Saul Berkovitz ◽  
Fawzi Attia ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Placebo Control ◽  
Severity Scale ◽  
Double Blind ◽  
Significance Level ◽  
Nail Bed ◽  
Published Evidence ◽  
Related Quality ◽  
Future Evaluation

10103 Background: Nail damage is common amongst patients receiving chemotherapy, especially taxanes, causing pain, distress, disfigurement, infection and restricted daily activities. Cooling the nail beds helps but there has been no published evidence for the effectiveness of nail balms, despite their popular use. We investigated whether a topical nail bed balm containing bioactive polyphenolic rich African salvia officinalis, gaultheria procumbens in a natural base of olea europaea, butyrospermun parkii, cera alba and theobroma cacao protected the nail beds via their reported anti-inflammatory, analgesic, anti-oxidant and anti-microbial properties. Methods: 60 patients (23 male, 37 female) were randomized to apply to their nail bed (tds) the natural balm or a petroleum balm suitably scented for a placebo control. Demographics, type and number of chemotherapy cycles did not differ between the two groups, recruited between Sept 2016-Sept 2017. At baseline and at the end of chemotherapy both patients and physicians measured outcomes of nail health. Patients completed a Dermatology Life Quality questionnaire and a linear severity scale; physician completed a Nail Psoriasis Index (NPSI) and a linear severity scale based on clinical examination and photographs. Differences were analyzed using an unpaired t-test; significance level α = 0.05 at 95% confidence intervals (CI); probability (p). Results: The mean change in nail health outcomes over the course of chemotherapy were: (see table). Conclusions: The polyphenolics rich essential oils and plant-based waxes in this nail bed balm profoundly reduced chemotherapy related nail damage and improved nail related quality of life compared to a plain petroleum based balm. A future evaluation combining nail bed cooling and this natural balm is planned. Clinical trial information: 015-001866-24. [Table: see text]

scholarly journals Multi-Strain Probiotic Supplementation with a Product Containing Human-Native S. salivarius K12 in Healthy Adults Increases Oral S. salivarius

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4392
Author(s):  
Karina Cernioglo ◽  
Karen M. Kalanetra ◽  
Anna Meier ◽  
Zachery T. Lewis ◽  
Mark A. Underwood ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Amplicon Sequencing ◽  
Healthy Adults ◽  
Oral Microbiome ◽  
Placebo Control ◽  
Upper Respiratory Tract ◽  
Double Blind ◽  
16S Rrna Amplicon Sequencing ◽  
Supplementation Period ◽  
Tract Infections

Streptococcus salivarius (S. salivarius) K12 supplementation has been found to reduce the risk of recurrent upper respiratory tract infections. Yet, studies have not reported the effect of supplementation on oral S. salivarius K12 levels or the salivary microbiome. This clinical trial was designed to determine how supplementation with S. salivarius K12 influences the oral microbiome. In a randomized, double-blind, placebo-controlled trial, 13 healthy adults received a probiotic powder (PRO) containing Lactobacillus acidophilus, Bifidobacterium lactis, and S. salivarius K12 and 12 healthy adults received a placebo-control powder (CON) (n = 12) for 14 consecutive days. Oral S. salivarius K12 and total bacteria were quantified by qPCR and the overall oral microbiome was measured using 16S rRNA amplicon sequencing. Supplementation significantly increased mean salivary S. salivarius K12 levels by 5 logs compared to baseline for the PRO group (p < 0.0005), which returned to baseline 2 weeks post-supplementation. Compared with the CON group, salivary S. salivarius K12 was 5 logs higher in the PRO group at the end of the supplementation period (p < 0.001). Neither time nor supplementation influenced the overall oral microbiome. Supplementation with a probiotic cocktail containing S. salivarius K12 for two weeks significantly increased levels of salivary S. salivarius K12.

scholarly journals Efficacy of a spatial repellent for control of malaria in Indonesia: a cluster-randomized controlled trial

2019 ◽  
Author(s):  
Din Syafruddin ◽  
Puji BS Asih ◽  
Ismail Ekoprayitno Rozi ◽  
Dendi Hadi Permana ◽  
Anggi Puspa Nur Hidayati ◽  
...  
Keyword(s):  
Protective Effect ◽  
Protective Efficacy ◽  
Controlled Trial ◽  
Effective Means ◽  
Placebo Control ◽  
Radical Cure ◽  
Significance Level ◽  
Spatial Repellent ◽  
Cluster Randomized ◽  
First Time

AbstractA cluster randomized, double-blinded, placebo-controlled trial was conducted to estimate protective efficacy of a spatial repellent against malaria infection at Sumba, Indonesia. Following radical cure in 1,341 children aged ≥ 6 months - ≤5 years in 24 clusters, households were given transfluthrin or placebo passive emanators (devices designed to release vaporized chemical). Monthly blood screening and biweekly human-landing mosquito catches were performed during 10-months baseline (June 2015 to March 2016) and a 24-month intervention period (April 2016 to April 2018). Screening detected 164 first-time infections and an accumulative total of 459 infections in 667 subjects in placebo-control households; and 134 first-time and 253 accumulative total infections among 665 subjects in active intervention households. The 24-cluster protective effect of 27.7% and 31.3%, for time to first-event and overall (total new) infections, respectively, was not statistically significant. Purportedly, this was due in part to zero to low incidence in some clusters, undermining the ability to detect a protective effect. Subgroup analysis of 19 clusters where at least one infection occurred during baseline showed 33.3% (p-value = 0.083) and 40.9% (p-value = 0.0236, statistically significant at the 1-sided 5% significance level) protective effect to first-infection and overall infections, respectively. Among 12 moderate-to high-risk clusters, a statistically significant decrease on infection by intervention was detected (60% protective efficacy). Primary entomological analysis of impact was inconclusive. While this study suggests spatial repellents prevent malaria, additional evidence is required to demonstrate the product class provides an operationally feasible and effective means of reducing malaria transmission.

scholarly journals Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Su Li ◽  
Cang Zhang ◽  
Hong-Ya Zhang ◽  
Meng Zhou ◽  
Si-Nong Wang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Severity Index ◽  
Placebo Treatment ◽  
International Standards ◽  
Physician Global Assessment ◽  
Double Blind ◽  
Objective Evidence ◽  
Multicenter Randomized Controlled Trial ◽  
Heat Syndrome

Introduction. The etiology and pathogenesis of psoriasis are complex. Blood-heat syndrome is the core pathogenesis of psoriasis. Based on theories of Chinese medicine (CM), heat-clearing and blood-cooling (HCBC) are the primary treatment. Very few studies have investigated the pharmacological mechanism of the CM HCBC method for treating psoriasis. This multicenter randomized controlled trial will focus on treating psoriasis blood-heat syndrome with the HCBC method using Jueyin granules (JYKL). This will be an objective and standardized evaluation of the efficacy, safety, and reproducibility of the HCBC method to obtain objective evidence meeting international standards that aim to establish a clinical standard suitable for the popular application of CM for treating psoriasis. Methods and Analysis. A five-center randomized double-blind placebo-controlled clinical design will be used in this study. At least 196 participants will be randomly assigned to receive either JYKL or placebo treatment approximately 30 minutes after meals in the morning and evening (one sachet per time, twice daily for 8 consecutive weeks). The study duration will be 17 weeks, including 1 week of screening, 8 weeks of intervention, and 8 weeks of follow-up. The patients will be evaluated every 2 weeks, and the measures will be compared with baseline values. The primary outcome measure will be the psoriasis lesion area severity index. We will also observe the recurrence rate, body surface area, physician global assessment, dermatology life quality index, quality of life index, visual analogue scale score, CM symptom score, combined drug use, and adverse events. This trial is registered with NCT03961230.

Randomized phase II trial of the neurokinin-1 receptor antagonist (NK-1 RA) casopitant mesylate with ondansetron (ond)/dexamethasone (dex) for chemotherapy-induced nausea/vomiting (CINV) in patients (pts) receiving highly emetogenic chemotherapy (HEC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8513-8513 ◽  
Author(s):  
J. Rolski ◽  
R. Ramlau ◽  
M. Dediu ◽  
M. W. Russo ◽  
G. A. Ross ◽  
...  
Keyword(s):  
Receptor Antagonist ◽  
Complete Response ◽  
Trend Test ◽  
Placebo Control ◽  
Double Blind ◽  
Therapy Regimen ◽  
Armitage Trend Test ◽  
Neurokinin 1 ◽  
Intent To Treat ◽  
Future Evaluation

8513 Background: A combination of a 5-HT3 receptor antagonist (5-HT3 RA) + dex is standard for prevention of CINV due to HEC. However, NK-1 RAs are now also of interest. The current trial evaluated casopitant mesylate, a potent, oral, selective NK-1 RA, in a triple therapy regimen with a 5-HT3 RA and dex in pts receiving HEC. Methods: In this multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study, pts receiving HEC were stratified by gender and randomized among six arms. HEC consisted of regimens including cisplatin ≥ 70 mg/m2 IV over 1–4 hours (h) day 1 (D1). All pts received ond 32mg IV D1 and dex PO D1–4 with either placebo control, casopitant 50mg QD D1–3, casopitant 100mg QD D1–3, or casopitant 150mg QD D1–3. Pts on exploratory arms received ond/dex plus either casopitant 150 mg D1 only or aprepitant 125mg D1 and 80mg D2–3. The primary endpoint was complete response (CR) rate (no vomiting, retching, rescue medications or premature withdrawals) during the first 120 h following initiation of HEC. Target intent-to-treat (ITT) group enrollment was 82 pts per arm. Results: 493 enrolled patients comprised the ITT group. CR rate was 60% in the control arm; 76% for casopitant 50mg; 86% for 100mg; and 77% for 150mg (p=.0036, Cochran-Armitage trend test). CR rate was 75% with casopitant 150 mg D1 and 72% for 3-day aprepitant. CR rates at 24 h were similar in all groups (86%-96%). Casopitant prolonged time to emesis (p=.0029) and increased the proportion of pts without vomiting (p=.0122) relative to control. There were no differences in rates of nausea or use of rescue medication among groups. Adverse events were similar across all arms, with neutropenia, nausea, and hiccups (≤ 17%) as most common. All casopitant doses were generally well tolerated. Conclusions: The addition of casopitant to ond/dex at all doses tested and in 1- or 3-day administration regimens was well tolerated and significantly reduced CINV rates over a 5-day period in pts receiving HEC. The results of the exploratory 1-day regimen are of particular interest for future evaluation. [Table: see text]

A prospective multicenter trial of S-1 with lafutidine vs S-1 as adjuvant chemotherapy for gastric cancer in Japan: AEOLUS.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 91-91
Author(s):  
Nozomu Machida ◽  
Masanori Terashima ◽  
Keisei Taku ◽  
Takashi Daimon ◽  
Masashi Kimura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Chemotherapy ◽  
Dose Reduction ◽  
Treatment Completion ◽  
Multicenter Trial ◽  
Completion Rate ◽  
Placebo Control ◽  
Double Blind ◽  
Cytologic Examination ◽  
Significance Level

91 Background: From the result of ACTS-GC study, adjuvant chemotherapy with S-1 for one year is standard therapy of gastric cancer in Japan. In this study, completion rate of pre-planned S-1 treatment was 65.8% and there is still room for improvement on this rate. Lafutidine is a H2 blocker and enhances submucosal blood flow via capsaicin-sensitive afferent neurons. Alleviating effect of lafutidine on toxicity of 5FU leading to discontinuation of adjuvant treatment could be expected. Methods: Patients with histologically confirmed stage II (excluding T1 cases), IIIA, or IIIB (Japanese Classification of Gastric Carcinoma 13th) who underwent gastrectomy with D2 lymphadenectomy were randomly assigned to receive S-1 with lafutidine(L) or S-1 (S). All patients were given S-1 (40mg/m2) for 4 weeks with 2 weeks rest, repeated for 1 year after surgery. Patients of L group received lafutidine (20mg/day) every day for 1 year with S-1. The primary end point was treatment completion rate (TCR) of S-1. Definition of treatment completion was S-1 continuation for 1 year with over 70% planned dose. The secondary end points were toxicity (CTCAE v3.0) and relative total administration dose (RD) of S-1. Results: We randomly assigned 101 patients to the L group and 101 patients to the S group between February 2010 and December 2012 from 17 centers in Japan. After randomization, two patients were found to be ineligible in L group (the absence of cytologic examination of the peritoneal fluid, stageIB) and 1 in S group (allocation violation). TCR was 68.3% in the L group and 60.4% in the S group (p = 0.072, Cochran-Mantel-Haenzel test at a pre-specified one-sided significance level of 0.1). Adverse events of grade 3/4 excluding ineligible example was 30.0% in the L group, and 36.0% in the S group. Patients who require a dose reduction and/or delay of S-1 was 41.6% in the L group, and 51.5% in the S group. RD was 83.9% (range: 1.6-103.7) in the L group, and 84.0% (range: 1.7-103.8) in the S group. No any toxicity of lafutidine was observed. Conclusions: Lafutidine may increase a completion rate of adjuvant chemotherapy using S-1 within a 30% dose reduction for gastric cancer. This result need to be confirmed in double-blind placebo control study. Clinical trial information: UMIN000002703.

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