Effectiveness of modified Whitfield’s ointment with oral griseofulvin in the treatment of dermatophytosis poorly responsive to            standard antifungal therapy: a randomized, double blind, within patient placebo control

Background: Dermatophytosis is a superficial fungal infection found in hot and humid areas particularly in tropical regions and affects the keratinized regions of the body. It is usually treated with a combination of topical and systemic antifungal therapy as well as improved hygienic measures. Over the last few decades there has been an increase in the prevalence of dermatophyte infections which are poorly responding to standard antifungal therapy.Methods: Modified Whitfield’s ointment is a combination of 5%-5% Salicylic acid and Benzoic acid with an emulsifying ointment as a vehicle which has both a fungistatic and a keratolytic action. Oral Griseofulvin is a systemic antifungal agent which is a fungistatic agent. The combination of the above agents is synergistic. A randomized double blind, within-patient-placebo-controlled trial was designed for the treatment of dermatophytosis poorly responsive to standard antifungal therapy.Conclusions: This may shed light on the treatment of dermatophytosis poorly responsive to standard antifungal therapy.Trial Registration: This trial is registered with WHO trial registry number (Universal trial number): U111-1235-8791.

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

Nutrients ◽

10.3390/nu13124392 ◽

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.

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Evaluation of the safety and tolerability of a nutritional Formulation in patients with ANgelman Syndrome (FANS): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3996-x ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Donna L. Herber ◽

Edwin J. Weeber ◽

Dominic P. D’Agostino ◽

Jessica Duis

Keyword(s):

Angelman Syndrome ◽

Ketone Bodies ◽

Controlled Trial ◽

The Body ◽

Metabolic Efficiency ◽

Double Blind ◽

Carbohydrate Consumption ◽

Gastrointestinal Health ◽

Glucose Levels ◽

Beta Hydroxybutyrate

Abstract Background Ketogenic and low-glycemic-index diets are effective in treating drug-resistant seizures in children with Angelman syndrome. Cognition, mobility, sleep, and gastrointestinal health are intrinsically linked to seizure activity and overall quality of life. Ketogenic and low-glycemic diets restrict carbohydrate consumption and stabilize blood glucose levels. The ketogenic diet induces ketosis, a metabolic state where ketone bodies are preferentially used for fuel. The use of exogenous ketones in promoting ketosis in Angelman syndrome has not been previously studied. The study formulation evaluated herein contains the exogenous ketone beta-hydroxybutyrate to rapidly shift the body towards ketosis, resulting in enhanced metabolic efficiency. Methods/design This is a 16-week, randomized, double-blind, placebo-controlled, crossover study to assess the safety and tolerability of a nutritional formula containing exogenous ketones. It also examines the potential for exogenous ketones to improve the patient’s nutritional status which can impact the physiologic, symptomatic, and health outcome liabilities of living with Angelman syndrome. Discussion This manuscript outlines the rationale for a study designed to be the first to provide data on nutritional approaches for patients with Angelman syndrome using exogenous ketones. Trial registration ClinicalTrials.gov, ID: NCT03644693. Registered on 23 August 2018. Last updated on 23 August 2018.

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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.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.10103 ◽

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]

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The Evaluation of the Body Weight Lowering Effects of Herbal Extract THI on Exercising Healthy Overweight Humans: A Randomized Double-Blind, Placebo-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/758273 ◽

2013 ◽

Vol 2013 ◽

pp. 1-8 ◽

Cited By ~ 2

Author(s):

Soo Hyun Cho ◽

Yoosik Yoon ◽

Young Yang

Keyword(s):

Body Weight ◽

Controlled Trial ◽

Safety Evaluation ◽

Hdl Cholesterol ◽

Treated Group ◽

The Body ◽

Herbal Extract ◽

Double Blind ◽

The Difference ◽

Group 2

We investigated the effects of herbal extracts, a mixture of Scutellariae Radix and Platycodi Radix containing the active ingredients Baicalin and Saponin (target herbal ingredient (THI)), on lowering body weight. The present study was a prospective, randomized, double-blind, and placebo-controlled trial carried out at the outpatient department of a hospital over a period of 2 months. Group 1 patients (n=30) received THI, and group 2 patients (n=23) received placebo three times a day before meals. Weight, waist circumference, BMI, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and glucose were measured at baseline and again at the 2nd month. For safety evaluation, various hematological and biochemical parameters were assessed. Values of mean change of weight in the THI-treated group were−1.16±1.41 kg and in the placebo-treated group were−0.24±1.70 kg, respectively. The difference in mean change of weight in the THI-treated group compared with that in the placebo-treated group was statistically significant (P<0.05). The incidence of subjective and objective adverse drug reactions was insignificant (P>0.05). THI was statistically significant in its effectiveness on the weight loss.

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Raloxifene and body composition and muscle strength in postmenopausal women: a randomized, double-blind, placebo-controlled trial

Acta Endocrinologica ◽

10.1530/eje-09-0619 ◽

2010 ◽

Vol 162 (2) ◽

pp. 371-376 ◽

Cited By ~ 12

Author(s):

Didy E Jacobsen ◽

Monique M Samson ◽

Marielle H Emmelot-Vonk ◽

Harald J J Verhaar

Keyword(s):

Body Composition ◽

Placebo Group ◽

Muscle Strength ◽

Postmenopausal Women ◽

Controlled Trial ◽

Group Versus ◽

The Body ◽

Fat Free Mass ◽

Double Blind ◽

Double Blind Placebo

ObjectiveTo compare the effects of raloxifene and placebo on body composition and muscle strength.DesignRandomized, double-blind, placebo-controlled trial involving 198 healthy women aged 70 years or older conducted between July 2003 and January 2008 at the University Medical Centre, Utrecht, The Netherlands.MethodsParticipants were randomly assigned to receive raloxifene 60 mg or placebo daily for 12 months. Measurements were taken at baseline, 3, 6, and 12 months, and change from baseline was calculated. Main outcome measures were body composition (bioelectrical impedance analysis), muscle strength, and muscle power (maximum voluntary isometric knee extension strength, explosive leg extensor power, and handgrip strength).ResultsAt 12 months, the body composition of women taking raloxifene was significantly different from that of women taking placebo: fat-free mass (FFM) had increased by a mean of 0.83 (2.4) kg in the raloxifene group versus 0.03 (1.5) kg in the placebo group (P=0.05), and total body water had increased by a mean of 0.6 (1.8) litres in the raloxifene group versus a decrease of 0.06 (1.1) litres in the placebo group (P=0.02). Muscle strength and power were not significantly different.ConclusionRaloxifene significantly changed body composition (increased FFM; increased water content) compared with placebo in postmenopausal women.

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Evaluation of the Safety and Tolerability of a Nutritional Formulation in Patients with Angelman Syndrome (FANS): Study Protocol for a Randomized Controlled Trial

10.21203/rs.2.13020/v1 ◽

2019 ◽

Author(s):

Donna L. Herber ◽

Edwin J. Weeber ◽

Dominic P. D’Agostino ◽

Jessica Duis

Keyword(s):

Angelman Syndrome ◽

Ketone Bodies ◽

Controlled Trial ◽

The Body ◽

Metabolic Efficiency ◽

Double Blind ◽

Carbohydrate Consumption ◽

Gastrointestinal Health ◽

Glucose Levels ◽

Beta Hydroxybutyrate

Abstract Background Ketogenic and low glycemic index diets are effective in treating drug resistant seizures in children with Angelman syndrome. Cognition, mobility, sleep, and gastrointestinal health are intrinsically linked to seizure activity and overall quality of life. Ketogenic and low glycemic diets restrict carbohydrate consumption and stabilize blood glucose levels. The ketogenic diet induces ketosis, a metabolic state where ketone bodies are preferentially used for fuel. The use of exogenous ketones in promoting ketosis in Angelman syndrome has not been previously studied. The study formulation evaluated herein contains the exogenous ketone beta-hydroxybutyrate to rapidly shift the body towards ketosis, resulting in enhanced metabolic efficiency. Methods This is a 16 week, randomized, double blind, placebo-controlled crossover study to assess the safety and tolerability of a nutritional formula containing exogenous ketones. It also examines the potential for exogenous ketones to improve the patient’s nutritional status which can impact the physiologic, symptomatic, and health outcomes liabilities of living with Angelman syndrome. Discussion This manuscript outlines the rationale for a study designed to be the first to provide data on nutritional approaches for patients with Angelman syndrome using exogenous ketones. Trial Registration: ClinicalTrials.gov, identifier: NCT03644693; Registered on 23 August 2018. Last Updated on 23 August 2018.

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Metal excretion and magnesium retention in patients with intermittent claudication treated with intravenous disodium EDTA

Clinical Chemistry ◽

10.1093/clinchem/42.12.1938 ◽

1996 ◽

Vol 42 (12) ◽

pp. 1938-1942 ◽

Cited By ~ 13

Author(s):

B Guldager ◽

P J Jørgensen ◽

P Grandjean

Keyword(s):

Intermittent Claudication ◽

Controlled Trial ◽

Serum Zinc ◽

Blood Lead ◽

Treated Group ◽

The Body ◽

Control Group ◽

Disodium Edta ◽

Double Blind ◽

Blood Concentrations

Abstract Sixty patients with intermittent claudication participated in a double-blind placebo-controlled trial of 20 courses of intravenous chelation therapy with 3 g of disodium EDTA vs placebo during 5-9 weeks. After the first infusion, the 24-h urinary excretion of lead and zinc was approximately 25-fold higher in the EDTA-treated group; relative differences for copper and calcium were smaller. Urinary magnesium excretion in the EDTA-treated group was one-third less than in the control group. After the treatment period, the blood lead concentration had decreased by approximately 73% and the serum zinc concentration by approximately 34%; other changes in blood concentrations were negligible. The loss of essential minerals and the possible redistribution of lead in the body may constitute a disadvantage that should be taken into account in repeated intravenous EDTA treatment.

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LiMA: a study protocol for a randomised, double-blind, placebo controlled trial of lisdexamfetamine for the treatment of methamphetamine dependence

BMJ Open ◽

10.1136/bmjopen-2017-020723 ◽

2018 ◽

Vol 8 (7) ◽

pp. e020723 ◽

Cited By ~ 3

Author(s):

Nadine Ezard ◽

Adrian Dunlop ◽

Michelle Hall ◽

Robert Ali ◽

Rebecca McKetin ◽

...

Keyword(s):

Psychosocial Functioning ◽

Controlled Trial ◽

Self Report ◽

Transmission Risk ◽

Health Concern ◽

Placebo Control ◽

Physical And Mental Health ◽

Double Blind ◽

Methamphetamine Use ◽

Methamphetamine Dependence

IntroductionMethamphetamine dependence is a growing public health concern. There is currently no pharmacotherapy approved for methamphetamine dependence. Lisdexamfetamine (LDX) dimesylate, used in the treatment of attention-deficit hyperactivity disorder and binge eating disorder, has potential as an agonist therapy for methamphetamine dependence, and possible benefits of reduced risk of aberrant use due to its novel formulation.Methods and analysisA double-blind randomised controlled trial will be used to evaluate the efficacy of LDX in reducing methamphetamine use. The target sample is 180 participants with methamphetamine dependence of ≥2 years, using ≥14 days out of the previous 28, who have previously attempted but not responded to treatment for methamphetamine use. Participants will be randomly assigned to receive either a 15-week intervention consisting of induction (1 week of 150 mg LDX or placebo), maintenance (12 weeks of 250 mg LDX or placebo) and reduction (1 week of 150 mg LDX or placebo and 1 week of 50 mg LDX or placebo). All participants will be given access to four sessions of cognitive–behavioural therapy as treatment as usual and receive a 4-week follow-up appointment. The primary outcomes are efficacy (change from baseline in days of methamphetamine use by self-report for the last 28 days at week 13 and urinalyses confirmation of methamphetamine use) and safety (treatment-related adverse events). Secondary outcomes are total number of days of self-report methamphetamine use over the 12-week active treatment, longest period of abstinence during treatment period, percentage of achieving ≥21 days abstinence, craving, withdrawal, dependence, retention, bloodborne virus transmission risk behaviour, criminal behaviour, as well measures of abuse liability, physical and mental health, other substance use, cognitive performance, psychosocial functioning, treatment retention and satisfaction. Additionally, the study will assess the cost-effectiveness of LDX relative to the placebo control.Ethics and disseminationThe study has been approved by the Human Research Ethics Committee of St. Vincent’s Hospital, Sydney, Australia (HREC/16/SVH/222). Contact the corresponding author for the full trial protocol.Trial registration numberACTRN12617000657325; Pre-results.

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Adipose-Derived Cells

Cell Transplantation ◽

10.3727/096368907783338190 ◽

2007 ◽

Vol 16 (9) ◽

pp. 963-970 ◽

Cited By ~ 86

Author(s):

Emanuele Meliga ◽

Brian M. Strem ◽

H. J. Duckers ◽

Patrick W. Serruys

Keyword(s):

Stem Cells ◽

Adipose Tissue ◽

Growth Factor ◽

Progenitor Cells ◽

Developmental Plasticity ◽

Controlled Trial ◽

The Body ◽

Functional Improvement ◽

Great Promise ◽

Double Blind

Heart failure is by far the most common cause of hospitalization in Western countries, with onerous economic consequences. Cell therapy holds great promise for use in tissue regeneration and is increasingly used in an effort to improve outcomes in cardiac disease. Recently it has been shown that adipose tissue, in addition to committed adipogenic, endothelial progenitor cells and pluripotent vascular progenitor cells, also contains multipotent cell types (adipose-derived stem cells, ADSCs) that, in cell culture conditions, have shown to have an impressive developmental plasticity including the ability to undergo multilineage differentiation and self-renewal. ADSCs express multiple CD marker antigens similar to those observed on MSCs and are also capable of secreting a large number of angiogenesis-related cytokines, including vascular endothelial growth factor, granulocyte/macrophage colony stimulating factor, stromal-derived factor-1α, and hepatocyte growth factor. Adipose tissue can be harvested in large quantities with minimal morbidity in several regions of the body and, on average, 100 ml of human adipose tissue yields about 1 × 106 stem cells. Studies conducted in porcine AMI models have shown a significant LV functional improvement, with no report of any potentially fatal arrhythmias. The APOLLO trial, a prospective, double blind, randomized, placebo-controlled trial currently in the recruiting phase, is a “first-in-man” study that explores the safety and feasibility of ADSC transplantation in patients with acute MI.

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Serum Vascular Endothelial Growth Factor Levels Lack Predictive Value in Patients with Active Ankylosing Spondylitis Treated with Golimumab

The Journal of Rheumatology ◽

10.3899/jrheum.150897 ◽

2016 ◽

Vol 43 (5) ◽

pp. 901-906 ◽

Cited By ~ 8

Author(s):

Jürgen Braun ◽

Xenofon Baraliakos ◽

Kay-Geert A. Hermann ◽

Stephen Xu ◽

Benjamin Hsu

Keyword(s):

Vascular Endothelial Growth Factor ◽

Ankylosing Spondylitis ◽

Growth Factor ◽

Controlled Trial ◽

Placebo Control ◽

Vascular Endothelial ◽

Double Blind ◽

Link Type ◽

Increased Risk ◽

Endothelial Growth Factor

Objective.To assess vascular endothelial growth factor (VEGF) correlations with new bone formation and bone marrow edema in patients with ankylosing spondylitis (AS) treated with golimumab (GOL).Methods.Following placebo control (through weeks 16 and 24), GO-RAISE (A Multicenter Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNF-α Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis; ClinicalTrials.gov: NCT00265083) all patients received GOL; sera/images were available at weeks 0, 104, and 208. Lateral spinal radiographs and magnetic resonance imaging (MRI) were scored using the modified Stokes Ankylosing Spondylitis Spine Score (mSASSS) and the Ankylosing Spondylitis Spinal MRI activity score, respectively.Results.VEGF levels and the mSASSS did not significantly correlate. Logistic regression analyses showed no association between VEGF levels and an increased risk of syndesmophyte formation at weeks 104 and 208. Pretreatment/Week 14 VEGF did not predict MRI scores/changes at Week 104.Conclusion.Serum VEGF did not predict radiographic progression/spinal inflammation in patients receiving antitumor necrosis factor.

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