scholarly journals A randomized open label parallel group study comparing the safety, effectiveness and adherence between 2% fusidic acid cream versus 1% retapamulin ointment in children with impetigo

2019 ◽  
Vol 8 (3) ◽  
pp. 446
Author(s):  
Jeevimani Venkata Subba Reddy ◽  
Vijaya Mohan Rao ◽  
Buchineni Madhavulu ◽  
B. L. Kudagi ◽  
Pathapati Rama Mohan
Keyword(s):  
Fusidic Acid ◽  
Skin Infection ◽  
Rating Scale ◽  
Clinical Success ◽  
Signs And Symptoms ◽  
Cost Effective ◽  
Open Label ◽  
Severity Of Disease ◽  
Parallel Group ◽  
Adults And Children

Background: Impetigo is a contagious bacterial skin infection that affects both adults and children. Topical antibacterials such as mupirocin and fusidic acid are the most commonly used in both primary and secondary impetigo. Clinical trials have shown high efficacy of retapamulin in the treatment of secondary impetigo. However, its use in primary impetigo is limited. To this purpose, we compared the safety, efficacy and adherence to treatment of fusidic acid with retapamulin in primary impetigo.Methods: A total of 50 patients with a clinical diagnosis of primary impetigo, between 2-12 years of age, having <10 lesions, 3/5 signs and symptoms, skin infection rating score ≥4 and pus score ≥ one were involved. Patients who were having secondary impetigo leions were excluded.  Twenty-five patients received 2% fusidic acid cream three times a day, and the remaining 25 patients received 1% retapamulin ointment two times a day for seven days. Skin Infection Rating Scale (SIRS) was used to assess the severity of disease at baseline and end of treatment. Clinical success was considered when SIRS score of zero each for pus, crust and pain and 0/1 each for erythema and itching. Clinical failure is a SIRS score of ≥1 for pus.Results: Baseline disease characteristics such as a number of lesions, the severity of disease (SIRS) and pus scores were statistically similar between the two groups. The clinical improvement observed with both fusidic acid and Retapamulin (20/25, 80%) and (21/25, 84%) treatments was not statistically different (p>0.05). Both drugs were well tolerated.Conclusions: Both fusidic and retapamulin showed similar clinical success in patients with primary impetigo. Since fusidic acid has anti-inflammatory property and its treatment is cost-effective, it can be considered as first-line treatment and retapamulin in fusidic acid-resistant impetigo.

scholarly journals A randomised open label comparative study evaluating the effectiveness, adherence and safety between 2% mupirocin ointment and 2% fusidic acid cream in children with impetigo

2019 ◽  
Vol 5 (3) ◽  
pp. 511
Author(s):  
Ravichandran Velappan ◽  
Sindhuja Ramasamy ◽  
Shridhar Venu ◽  
Muthusubramanian Chandrasekar
Keyword(s):  
Fusidic Acid ◽  
Skin Infection ◽  
Clinical Success ◽  
Cost Effective ◽  
Open Label ◽  
College Hospital ◽  
Medical College ◽  
Disease Characteristics ◽  
Mupirocin Ointment ◽  
Systemic Antibiotics

<p class="abstract"><strong>Background:</strong> Impetigo is a superficial bacterial skin infection that affects mainly children, which is highly contagious. Topical anti-bacterials are most commonly used in both primary and secondary impetigo. Clinical trials have shown high efficacy of these topicals along with systemic antibiotics in both complicated and uncomplicated impetigo. However use of these topical modalities alone in uncomplicated primary impetigo is limited. The aim of the study was to compare the efficacy, safety and adherence to treatment of mupirocin with fusidic acid in primary impetigo.</p><p class="abstract"><strong>Methods:</strong> A total of 60 patients with a clinical diagnosis of primary impetigo, between 2-14 years of age, having &lt;10 lesions, skin infection rating score &gt;4 and pus score equal to or more than one who attended Dermatology OPD, in Chengalpattu Medical College Hospital from February 2018 to March 2019. Study design was a comparative analytical study.<strong></strong></p><p class="abstract"><strong>Results:</strong> Baseline disease characteristics such as number of lesions, the severity of disease (SIRS), and pus scores were statistically similar between the two groups. The clinical improvement observed with mupirocin (25/30) and fusidic acid (24/30) treatment in primary impetigo was not statistically significant (p&gt;0.05). Both drugs were tolerated well.</p><p><strong>Conclusions:</strong> Both mupirocin and fusidic acid showed similar clinical success in patients with primary impetigo. Though fusidic acid has additional anti-inflammatory property and its treatment is cost effective, but irritant effects observed in some patients, which reduces the compliance, lead to consider mupirocin as first line treatment in primary impetigo. </p>

scholarly journals Tolerability and Efficacy of Vortioxetine Versus SSRIs in Elderly With Major Depression. Study Protocol of the VESPA Study: A Pragmatic, Multicentre, Open-Label, Parallel-Group, Superiority, Randomized Trial

2020 ◽  
Author(s):  
Giovanni Ostuzzi ◽  
Chiara Gastaldon ◽  
Angelo Barbato ◽  
Barbara D’Avanzo ◽  
Mauro Tettamanti ◽  
...  
Keyword(s):  
Major Depression ◽  
Randomized Trial ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Rating Scales ◽  
Rating Scale ◽  
The Elderly ◽  
Tolerability Profile ◽  
Open Label ◽  
Parallel Group

Abstract Introduction. Depression is a highly prevalent condition in the elderly, with a vast impact on quality of life, life expectancy, and medical outcomes. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed agents in this condition and, although generally safe, tolerability issues cannot be overlooked. Vortioxetine is an antidepressant with a novel mechanism of action. Based on available studies, it may have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance, and does not alter cardiovascular and endocrine parameters. The present study aims to assess the tolerability profile of vortioxetine in comparison with the SSRIs considered as a single group in elderly participants with depression. The rate of participants withdrawing from treatment due to adverse events after six months of follow-up will be the primary outcome. Methods and analysis. This is a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial funded by the Italian Medicines Agency (AIFA - Agenzia Italiana del Farmaco ). Thirteen Italian Community Psychiatric Services will consecutively enrol elderly participants suffering from an episode of major depression over a period of 12 months. Participants will be assessed at baseline and after 1, 3 and 6 months of follow-up. At each time point, the following validated rating scales will be administered: Montgomery–Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Short Blessed Test (SBT), and Charlson Age-Comorbidity Index (CACI). Outcome assessors and the statistician will be masked to treatment allocation. A total of 358 participants (179 in each group) will be enrolled. Ethics and dissemination. This study will fully adhere to the ICH E6 Guideline for Good Clinical Practice. Participants’ data will be managed and safeguarded according to the European Data Protection Regulation 2016/679. An external Ethical Advisory Board will help guarantee high ethical standards. Trial registration number. EudraCT number: 2018-001444-66; Clinicaltrials.gov: NCT03779789, first submitted on December 12, 2018 and first posted on December 19 th trial status: protocol version 1.5; 09/06/2018. Recruitment started on February 2019 and it is ongoing. It is expected to end approximately on September 30 th 2021.

scholarly journals A comparative prospective open label randomized controlled 8 week study in patients of depression treated with vilazodone and sertraline

2020 ◽  
Vol 7 (4) ◽  
pp. 643
Author(s):  
Nirmal Arya ◽  
Anuradha Nischal ◽  
Anil Nischal ◽  
Manu Agarwal
Keyword(s):  
Side Effect ◽  
Rating Scale ◽  
Sexual Experience ◽  
Open Label ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Treatment Of Depression ◽  
Group A ◽  
Hamilton Anxiety Rating Scale ◽  
Group B

Background: Depression is a mood disorder treated with various antidepressant such as SSRIs due to lesser toxicity and improved safety profile.Methods: This was an eight week randomised active controlled parallel group study. 54 patients were allocated in two group. Group A received vilazodone while group B received sertraline. Assessment done at baseline, 2, 4 and 8 weeks on the basis of clinical efficacy, sexual dysfunction, side effects and weight gain using Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Arizona Sexual Experience Scale (ASEX) and UKU Side Effect Rating Scale.Results: HAM-D score of group A was 18.78±1.78 and 7.67±1.66 while in group B was 19.04±2.12 and 8.15±1.77 at baseline and 8 weeks respectively. HAM-A score of group A was 15.44±1.50 and 6.63±1.39 while in group B was 15.26±1.83 and 7.07±1.14 at baseline and 8 weeks. ASEX total score of group A was 15.63±1.28 and 14.63±1.33 while group B was 15.52±1.37 and 16.41±1.12 at baseline and 8 weeks. ASEX desire score of group A was 9.63±0.93 and 8.67±0.88 while of group B was 9.59±0.93 and 10.07±0.92 at baseline and 8 weeks. UKU side effect rating at 2 and 8 weeks of group A was 0.22±0.42, 1.04±0.76 while in group B was 0.37±0.49, 1.89±0.85.Conclusions: Vilazodone and Sertraline are equally efficacious in treatment of depression and associated anxiety. When side effect profile were compared Vilazodone is found superior to Sertraline

scholarly journals Comparison of efficacy of topical alcaftadine (0.25%) versus olopatadine (0.1%) in allergic conjunctivitis

2022 ◽  
Vol 7 (4) ◽  
pp. 630-633
Author(s):  
Kiran Kumar L ◽  
M S Smitha Gowda
Keyword(s):  
Allergic Conjunctivitis ◽  
Treatment Options ◽  
Signs And Symptoms ◽  
Outcome Variable ◽  
Eye Drops ◽  
Open Label ◽  
Parallel Group ◽  
Significant Efficacy ◽  
Group B ◽  
Olopatadine Hydrochloride

The most common atopic ocular condition in clinical practice is allergic conjunctivitis. One of the preferred treatment options for allergic Conjunctivitis is anti histamines eye drops. The study purpose is to compare the clinical efficacy between topical alcaftadine 0.25% and olopatadine hydrochloride 0.1% in allergic conjunctivitis patients.A prospective, randomized, open label, parallel group, comparative study was conducted on 60 Patients with bilateral allergic conjunctivitis (30 in each group) after taking an informed written consentand was evaluated from May 2018 to November 2018. Patients were randomized into 2 groups of 30 each, group A received topical Alcaftadine 0.25% twice daily and patients in Group B received topical olopatadine hydrochloride 0.1% twice daily for 2 weeks. The patients were evaluated on first visit (baseline) followed by 7 and 14 day after starting the treatment. At each visit signs and symptoms were evaluated and rated using a scale from 0-3(0-Absent, 1- mild, 2 moderate and 3- severe). The change from baseline in the mean scores of itching, hyperemia, photophobia and tearing on day 14 is the primary outcome variable.: The signs and symptoms of allergic conjunctivitis were reduced by 2 weeks from baseline after using both the drugs. Relative significant efficacy was achieved in alcaftadine group for Itching, hyperemia and photophobia, but not for tearing (p=0.3). When compared to 0.1% olopatadine hydrochloride, 0.25% alcaftadine is more effective in reducing the symptoms of all types of allergic conjunctivitis except those mentioned in exclusion criteria.

scholarly journals A Randomized Open Label Parallel Group Clinical Study to Evaluate the Efficacy and Safety of Clevira in Fever of Viral Origin

2019 ◽  
Vol 4 (09) ◽  
Author(s):  
Ramesh Kannan S. ◽  
Sivraman V. ◽  
Vanitha R. Muralikumar ◽  
Sakthibalan M. ◽  
Jayashree S. ◽  
...  
Keyword(s):  
Clinical Signs ◽  
Signs And Symptoms ◽  
Treated Group ◽  
Control Group ◽  
Efficacy And Safety ◽  
Structural Protein ◽  
Open Label ◽  
Serious Adverse Events ◽  
Viral Origin ◽  
Parallel Group

Objective: To evaluate the efficacy and safety of Clevira, an ayurvedic formulation in fever of viral origin. Methods: This was a prospective, randomised, multicentre, open label, parallel group interventional clinical end point study. Patients attending general outpatient department, were screened for viral fever including Dengue by using the haematological, Biochemical and microbiological anti body assay for Dengue and NS1 (Non-structural protein) antigen testing. Forty eight patients who satisfied the selection criteria were enrolled in the study. Participants were randomized into 4 groups with 12 patients in each group. Patients were given standard treatment. In addition, Tab. Clevira of Apex laboratories Pvt. Ltd., was administered to test groups. Results: There is highly significant improvement (P<0.001) in the subjects Temperature, fever score, arthralgia score, Myalgia score, Headache and loss of appetite, suggesting a good Analgesic and anti pyretic activity of Clevira. There is a significant improvement in platelet count in the Clevira treated group (P<0.01) when compared to the control group, proving its efficacy in treating thrombocytopenia. The improvement (P<0.01) in the WBC count in the Clevira treated group depicts the anti viral property of Clevira. The overall quality of life was better in Clevira treated group compared to the control group. There were no serious adverse events reported. Conclusion: Clevira is safe and efficacious in reversing thrombocytopenia and thus normalizing the platelet counts and relieving the clinical signs and symptoms (fever, myalgia, arthralgia, headache) of Viral fever associated with thrombocytopenia and other cases of viral fever without thrombocytopenia. Clevira is having good anti-viral, antipyretic, analgesic and immunomodulatory property. Hence, Clevira should be used as an add on drug in patients with viral fever with or without thrombocytopenia for a rapid recovery without any adverse effects.

The Feasibility of Optimal Surgical Result Prediction according to the Centre of Rotation Shift after Multilevel Cervical Total Disc Replacement

2018 ◽  
Vol 1 (2) ◽  
pp. 6
Author(s):  
Jun Ho Lee
Keyword(s):  
Rating Scale ◽  
Clinical Success ◽  
Total Disc Replacement ◽  
Numeric Rating Scale ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Consecutive Series ◽  
Cervical Total Disc Replacement ◽  
Successful Group ◽  
Centre Of Rotation

Objective: This study investigates the relation between shifted locations of centre of rotation (COR) at each cervical level and subsequent surgical outcomes after multilevel cervical total disc replacement (MCTDR) and identifies radiological parameter that corresponded to change of COR after MCTDR. Methods: The study included a consecutive series of 24 patients who were treated with MCTDR following diagnosis of multilevel cervical disc herniation or stenosis. Numeric rating scale (NRS), range of motion (ROM) at both C2-7 segment and TDR implanted levels, and the location of COR at TDR implanted level were evaluated at pre- and post-MCTDR. These parameters were compared between patients who experienced successful and unsuccessful pain relief.Results: The inherent CORs relatively at ventro-cranial coordinates have demonstrated significant migrations to dorso-caudal locations at each cervical levels, more prominent shifts for the successful group, after MCTDR switch. The unsuccessful group showed markedly reduced C2-7 ROM and reduced angular improvement at C2-7 as well as MCTDR level after surgery in comparison with the successful group. Postoperative C2-7 ROM was related to postoperative COR along the X-axis.Conclusions: The crucial determinants for clinical success after MCTDR, other than mere preservation of the ROM both at C2-7 and TDR implanted levels, was the restoration of COR from ventro-cranial location at degenerated cervical motion segment close to normal coordinates by posterior and inferior shifts after MCTDR. The position of COR along the X-axis after MCTDR was an important factor to determine maintenance of C2-7 RO.

Assessing the Knowledge, Attitude and Practice (KAP) among the newly diagnosed Prediabetes screened in selected districts of South India

2020 ◽  
Vol 11 (3) ◽  
pp. 4836-4846
Author(s):  
Mohsina Hyder K ◽  
Raja D ◽  
Jithin Mohan ◽  
Ponnusankar S
Keyword(s):  
Positive Attitude ◽  
Healthy Lifestyle ◽  
Negative Attitude ◽  
Cost Effective ◽  
High Risk Population ◽  
Newly Diagnosed ◽  
Lifestyle Modifications ◽  
Open Label ◽  
Attitude And Practice ◽  
Knowledge Attitude And Practice

Currently, 314 million people in the world are Prediabetes, and it is predicted that around 500 million would be burdened by the year 2025. Continuing education of diabetes and its complications is crucial, but it should be accompanied with regular assessment of Knowledge Attitude and Practice (KAP) among the high-risk population. That would play a cost-effective role in prevention and control of the disease.This study was carried out to assess the Knowledge, Attitude and Practice among the newly diagnosed Prediabetes screened over selected districts of South India.This study was conducted through prediabetes screening camps over districts of Calicut, Wayanad and Malappuram in Kerala and The Nilgiris district in Tamilnadu from September 2017 to October 2019. A questionnaire survey was done as a part of a prospective open-label interventional study with 308 prediabetes individuals. Baseline characteristics of the participants were obtained, and their knowledge, attitude and practice regarding Prediabetes were assessed. The finding of the present study revealed 90% of the respondents had poor knowledge, 9% had average knowledge, and only 1% had good knowledge of Prediabetes. In the attitude assessment, only 1.9% had a strongly positive attitude, 14% had a positive attitude, 54% had neutral attitude while 17% had a negative attitude and 13% had a strongly negative attitude. Regarding healthy lifestyle practices, 35.4% had a deplorable practice that scored below 6. Around half of the population, 52.3% had poor practice, 12% had proper training, while only 0.3% had a perfect practice.Knowledge and practice regarding lifestyle modifications among prediabetes participants were found to be reduced. 

Daily consumption of fermented soymilk helps to improve facial wrinkles in healthy postmenopausal women in a randomized, parallel-group, open-label trial

2018 ◽  
Vol 8 (2) ◽  
pp. 107 ◽  
Author(s):  
Mitsuyoshi Kano ◽  
Kazuyoshi Haga ◽  
Kouji Miyazaki ◽  
Fumiyasu Ishikawa
Keyword(s):  
Postmenopausal Women ◽  
Maximum Depth ◽  
Liquid Chromatography Mass Spectrometry ◽  
Daily Consumption ◽  
Open Label ◽  
Facial Wrinkle ◽  
Crow’S Feet ◽  
Parallel Group ◽  
Secondary Endpoints ◽  
Open Label Trial

Background: Soymilk fermented by lactobacilli and/or bifidobacteria is attracting attention due to the excellent bioavailability of its isoflavones. We investigated the effects of fermented soymilk containing high amounts of isoflavone aglycones on facial wrinkles and urinary isoflavones in postmenopausal women in a randomized, parallel-group, open-label trial. Healthy Japanese women were randomly divided into active (n = 44, mean age 56.3 ± 0.5) or control (n = 44, mean age 56.1 ± 0.5) groups, who consumed or did not consume a bottle of soymilk fermented by Bifidobacterium breve strain Yakult and Lactobacillus mali for 8 weeks. Maximum depth of wrinkles around the crow’s feet area and other wrinkle parameters were evaluated as primary and secondary endpoints respectively at weeks 0, 4, and 8 during the consumption period. Urinary isoflavone levels were determined by liquid chromatography-mass spectrometry. Results: The active group demonstrated significant improvements in the maximum depth (p=0.015) and average depth (p=0.04) of wrinkles, and significantly elevated urinary isoflavones (daidzein, genistein, and glycitein; each p < 0.001) compared with the control during the consumption period. No serious adverse effects were recorded.Conclusion: These findings suggest that fermented soymilk taken daily may improve facial wrinkles and elevate urinary isoflavones in healthy postmenopausal women.Key words: postmenopausal women; isoflavone; fermented soymilk; phytoestrogen; facial wrinkle 

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