scholarly journals Changes in the Diversity of Human Skin Microbiota to Cosmetic Serum Containing Prebiotics: Results from a Randomized Controlled Trial

2020 ◽  
Vol 10 (3) ◽  
pp. 91
Author(s):  
Ki-Bae Hong ◽  
Yang Hee Hong ◽  
Eun Young Jung ◽  
Kyungae Jo ◽  
Hyung Joo Suh
Keyword(s):  
Controlled Trial ◽  
Transepidermal Water Loss ◽  
Shannon Index ◽  
Water Holding Capacity ◽  
Controlled Clinical Trial ◽  
Skin Microbiota ◽  
Double Blind ◽  
Group Water ◽  
The Mean ◽  
Water Holding

Prebiotic treatment may rebalance the skin microbiota by regulating the growth of harmful and beneficial microorganisms. In this randomized, double-blind, placebo-controlled clinical trial (N = 60), we evaluated the effects of a cosmetic serum containing galacto-oligosaccharides (GOS) on the balance of the skin microbiota by measuring various skin parameters. The skin water-holding capacity between the control (ND) and experimental (NF) groups was significantly different after 8 weeks of serum treatment (p < 0.05). Similarly, changes in transepidermal water loss (TEWL) and the erythema index in the ND and NF groups were significantly different (p < 0.05). Furthermore, the wrinkle depth and Staphylococcus aureus population decreased in the NF group compared with those in the ND group (p < 0.05). The mean form factor, Shannon index, and Pediococcus population were significantly increased in the post-NF group compared with those in the post-ND group (p < 0.05). Finally, in the ND group, water-holding capacity was positively correlated with Enhydrobacter, whereas Enterobacteriaceae was negatively correlated with TEWL in the NF group. These results suggest that GOS inhibit the growth of harmful skin microbes and increase the population of beneficial microbes.

scholarly journals Changes in The Diversity of Human Skin Microbiota to Cosmetic Serum Containing Prebiotics: Results From A Randomized Controlled Trial

2020 ◽  
Author(s):  
Ki Bae Hong ◽  
Yang Hee Hong ◽  
Eun Young Jung ◽  
Kyungae Jo ◽  
Hyung Joo Suh
Keyword(s):  
Controlled Trial ◽  
Transepidermal Water Loss ◽  
Shannon Index ◽  
Water Holding Capacity ◽  
Controlled Clinical Trial ◽  
Skin Microbiota ◽  
Double Blind ◽  
Group Water ◽  
The Mean ◽  
Water Holding

Abstract Background: Prebiotic treatment may rebalance the skin microbiota by regulating the growth of harmful and beneficial microorganisms. Methods: In this randomized, double-blind, placebo-controlled clinical trial (N = 60), we evaluated the effects of a cosmetic serum containing galacto-oligosaccharides (GOS) on the balance of the skin microbiota by measuring various skin parameters. Results: The skin water-holding capacity between the control (ND) and experimental (NF) groups was significantly different after 8 weeks of serum treatment (p < 0.05). Similarly, changes in transepidermal water loss (TEWL) and the erythema index in the ND and NF groups were significantly different (p < 0.05). Furthermore, the wrinkle depth and Staphylococcus aureus population decreased in the NF group compared with those in the ND group (p < 0.05). The mean form factor, Shannon index, and Pediococcus population were significantly increased in the post-NF group compared with those in the post-ND group (p < 0.05). Finally, in the ND group, water-holding capacity was positively correlated with Enhydrobacter, whereas Enterobacteriaceae was negatively correlated with TEWL in the NF group. Conclusions: These results suggest that GOS inhibit the growth of harmful skin microbes and increase the population of beneficial microbes.

scholarly journals Effectiveness of Echium amoenum on premenstrual syndrome: a randomized, double-blind, controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Maryam Farahmand ◽  
Davood Khalili ◽  
Fahimeh Ramezani Tehrani ◽  
Gholamreza Amin ◽  
Reza Negarandeh
Keyword(s):  
Placebo Group ◽  
Premenstrual Syndrome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Estimating Equation ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Echium Amoenum ◽  
The Mean ◽  
And Control

Abstract Background The present study aimed to evaluate the effect of Echium amoenum (EA) on the severity of premenstrual syndrome (PMS) in comparison with placebo. Methods The present study was a randomized double-blind controlled clinical trial. A checklist questionnaire was completed by 120, 18 to 35-year-old, college students. And then, 84 eligible women (20 to 35 years old) were enrolled in the trial; they were randomly assigned to two groups of intervention (EA) and control (placebo), with 42 participants in each group. Participants in the intervention group received 450 mg capsules of EA per day (three times a day) from the 21st day of their menstrual cycle until the 3rd day of their next cycle for two consecutive cycles. The severity of PMS was measured and ranked using the premenstrual symptoms screening tool (PSST). The generalized estimating equation was used to compare the total score of the severity of PMS between the two groups. Results Sixty-nine women with regular menstrual cycles suffering from PMS completed the study. The mean scores of the symptoms in the EA group were 35.3 and 16.1 (P ≤ 0.001) at baseline and after 2 months, respectively, while the mean scores of the symptoms in the placebo group were 31.0 and 28.3 (P = 0.09) at baseline and after 2 months, respectively. The evaluation of the first and the second follow-ups in the intervention group showed that, after being adjusted for age and body mass index (P ≤ 0.001), the mean scores of the premenstrual syndrome, using GEE analysis, have decreased to 6.2 and 11.6, respectively. Conclusion Based on the results, in comparison with the placebo group, EA was found to be more effective in improving the symptoms of PMS, and is highly recommended for treatment of this syndrome. Trial registration IRCT2015110822779N3; Registration date: 2015–11–27.

A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

2011 ◽  
Vol 41 (10) ◽  
pp. 2159-2166 ◽  
Author(s):  
Y. Panahi ◽  
B. Rezazadeh Moghaddam ◽  
A. Sahebkar ◽  
M. Abbasi Nazari ◽  
F. Beiraghdar ◽  
...  
Keyword(s):  
Placebo Group ◽  
Post Traumatic Stress Disorder ◽  
Traumatic Stress ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Traumatic ◽  
The Mean

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

scholarly journals Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aziza Ajlan ◽  
Hassan Aleid ◽  
Tariq Zulfiquar Ali ◽  
Hala Joharji ◽  
Khalid Almeshari ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
De Novo ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind ◽  
Donor Specific Antibodies

Abstract Background Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated. Aims To compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol. Methods Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected outcomes 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. Secondary outcomes: a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) Trial registration The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.

TOP-PRO study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

Cephalalgia ◽  
2021 ◽  
pp. 033310242110474
Author(s):  
Debashish Chowdhury ◽  
Luv Bansal ◽  
Ashish Duggal ◽  
Debabrata Datta ◽  
Ankit Mundra ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Virus Disease ◽  
Controlled Trial ◽  
Preventive Treatment ◽  
Point Estimate ◽  
Tolerability Profile ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean

Objective The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine. Background Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence. Methods Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed. Results As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was −5.3 ± 1.2 vs −7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of −1.99 with a 95% confidence interval of −5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups. Conclusion Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile. Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Nalbuphine ER Tablets for Uremic Pruritus

2017 ◽  
Vol 46 (6) ◽  
pp. 450-458 ◽  
Author(s):  
Vandana S. Mathur ◽  
Jayant Kumar ◽  
Paul W. Crawford ◽  
Howard Hait ◽  
Thomas Sciascia ◽  
...  
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Hemodialysis Patients ◽  
Opioid Antagonist ◽  
Opioid Agonist ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Uremic Pruritus ◽  
The Mean

Background: Pruritus is a distressing hallmark of the uremic condition, affecting approximately 60% of hemodialysis patients. Abnormal endogenous opioid ligand activity at μ and κ-opioid receptors has been postulated as a mechanism in uremic pruritus. Nalbuphine is a μ-opioid antagonist and κ-opioid agonist. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 373 hemodialysis patients with moderate or severe uremic pruritus were randomized in a 1: 1:1 ratio to nalbuphine extended-release tablets 120 mg (NAL 120), 60 mg (NAL 60), or placebo and treated for 8 weeks. Three hundred seventy-one were analyzed for efficacy. The primary endpoint was the change from baseline to treatment weeks 7 and 8 in itching intensity on a Numerical Rating Scale (NRS, 0 [no itching]; 10 [worst possible itching]) using an intent-to-treat approach. The aim was to evaluate the safety and antipruritic efficacy of NAL. Results: The mean duration of itching was 3.2 years. From a baseline NRS of 6.9 (1.5), the mean NRS declined by 3.5 (2.4) and by 2.8 (2.2) in NAL 120 mg and the placebo groups, respectively (p = 0.017). There was no evidence of tolerance. A trend for less sleep disruption due to itching (p = 0.062, NAL 120 vs. placebo) was also observed. There were no significant differences between NAL 60 vs. placebo. Serious adverse events occurred in 6.7, 12.7, and 15.4% in the NAL 120, NAL 60, and placebo groups respectively. Conclusions: In this largest-to-date randomized controlled trial in uremic pruritus, NAL 120 durably and significantly reduced the itching intensity among hemodialysis patients.

scholarly journals Neurological Development and Iron Supplementation in Healthy Late-Preterm Neonates: A Randomized Double-Blind Controlled Trial

2021 ◽  
Author(s):  
Rita Luciano ◽  
Domenico Marco Romeo ◽  
Giuseppina Mancini ◽  
Serena Sivo ◽  
Carolina Dolci ◽  
...  
Keyword(s):  
Placebo Group ◽  
Iron Supplementation ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Neurological Development ◽  
Double Blind ◽  
Neurological Outcomes ◽  
Increased Risk ◽  
The Mean

Abstract ObjectiveLate-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelaeand iron deficiency. Aim of the study is to assess the positive effect of iron supplementation on neurological development in healthy LPT.DesignWe designed a perspective, randomized placebo-controlled double-blind trial. The newborns were randomized in two groups: thirty-three patients received martial prophylaxis, thirty-three placebo. Every patient was assessed using the Griffith Mental Development Scales (GMDS)-II edition at 12 months of post-conceptional age.SettingThe study was performed at the Neonatology Unit of Fondazione Policlinico Gemelli IRCCS.PatientsSixty-six healthy LPT infants born between 340⁄7 and 366⁄7 weeks of Gestational Age were enrolled in the study.InterventionsOne group received martial prophylaxis from the third week of life to six months of post-conceptional age (2 mg/kg/day of iron pidolate), the other received placebo.Main outcome measuresFifty-two of the enrolled infants were assessed using the GMDS at 12-month of post-conceptional age. Statistical analysis of the mean scores of the Griffith subscales was performed.ResultsThere was a difference in the mean Developmental Quotient (DQ) (p<0.01) between the two groups: Iron Group mean DQ 121.45+10.53 vs Placebo Group mean DQ 113.25+9.70. Moreover, mean scores of the Griffith subscales A, B and D showed significant differences between the two Groups (scale A p<0.05, scale B p<0.02, scale D p<0.01 respectively).ConclusionsOur data show that newborns who received iron supplementation during the first six months of life achieved significantly better neurological outcomes at GMDS than Placebo group.

scholarly journals Effect of antenatal dietary myo-inositol supplementation on the incidence of gestational diabetes mellitus and fetal outcome: protocol for a double-blind randomised controlled trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e055314
Author(s):  
Ibrahim Ibrahim ◽  
Hala Abdullahi ◽  
Yassin Fagier ◽  
Osman Ortashi ◽  
Annalisa Terrangera ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Controlled Trial ◽  
Tolerance Test ◽  
Dietary Advice ◽  
Controlled Clinical Trial ◽  
Oral Glucose ◽  
Double Blind ◽  
Registration Number

IntroductionGestational diabetes mellitus (GDM) affects 23.6% of Qatari women and is associated with maternal and perinatal morbidity and long-term risk of developing type 2 diabetes. A number of challenges exist with current interventions, including non-compliance with dietary advice, the reluctance of mothers to ingest metformin tablets or use insulin injections. These challenges highlight the importance of pursuing evidence-based prevention strategies. Myo-inositol is readily available as an US Food and Drug Administration-approved food supplement with emerging but limited evidence suggesting it may be beneficial in reducing the incidence of GDM. Further studies, such as this one, from different ethnic contexts and with differing risk factors, are urgently needed to assess myo-inositol effects on maternal and neonatal outcomes.Methods and analysisThis study is a prospective, randomised, double-blinded, placebo controlled clinical trial to either myo-inositol supplementation or placebo.We plan to enrol 640 pregnant women attending antenatal care at Sidra Medicine, Doha, Qatar, 320 in each arm. All participants will complete at least 12 weeks of supplementation prior to undertaking the Oral Glucose Tolerance Test at 24–28 weeks. The daily use of the trial supplementation will continue until the end of pregnancy. All outcome measures will be collected from the electronic medical records.Ethics and disseminationEthical approval for the study was obtained on 12 April 2021 from Sidra Medicine (IRB number 1538656). Results of the primary trial outcome and secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberProspectively registered on 26 May 2021. Registration number ISRCTN16448440 (ISRCTN registry).

scholarly journals A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

2021 ◽  
Author(s):  
Victor Ifeanyichukwu Modekwe ◽  
Jideofor Okechukwu Ugwu ◽  
Okechukwu Hyginus Ekwunife ◽  
Andrew Nwankwo Osuigwe ◽  
Jideofor Chukwuma Orakwe ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Categorical Variables ◽  
Paediatric Surgery ◽  
Peripheral Oxygen Saturation ◽  
Double Blind ◽  
Oral Ketamine ◽  
The Mean ◽  
Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

scholarly journals Treament and prevention of anemia with ferrous sulfate plus folic acid in children attending daycare centers in Goiânia, Goiás State, Brazil: a randomized controlled trial

2008 ◽  
Vol 24 (suppl 2) ◽  
pp. s259-s271 ◽  
Author(s):  
Maria Claret Costa Monteiro Hadler ◽  
Dirce Maria Sigulem ◽  
Maria de Fátima Costa Alves ◽  
Vinícius Montenegro Torres
Keyword(s):  
Folic Acid ◽  
Ferrous Sulfate ◽  
Controlled Trial ◽  
Acid Group ◽  
Hemoglobin Level ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Daycare Centers ◽  
Randomized Controlled

The objective of this study was to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid. A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goiás State, Brazil. The children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50µg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50µg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. Supplementation lasted approximately three months. Baseline anemia prevalence was 56.1% (95%CI: 48.9-63.1). After treatment, anemia prevalence in the folic acid group (14%) was lower than in the placebo group (34.9%) (p = 0.02). After prophylaxis in the non-anemic children, the incidence of anemia did not differ between the groups, but there was an increase in hemoglobin level in the folic acid group (p = 0.003). Iron plus folic acid was effective for the treatment of anemia and improvement of hemoglobin level in non-anemic children.

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