scholarly journals Evaluation of Hilo® Versus Daflon® in Patients Suffering from Hemorrhoids: A Randomized, Controlled, Open-labelled, Multicentric Study

2019 ◽  
pp. 1-12
Author(s):  
Bhupesh Dewan ◽  
Sarita Prabhu
Keyword(s):  
Treatment Duration ◽  
Clinical Symptoms ◽  
Research Centre ◽  
Proctoscopic Examination ◽  
Multicentric Study ◽  
Randomized Controlled ◽  
End Of Treatment ◽  
The Mean ◽  
To Receive ◽  
Major Adverse Events

Aims: To evaluate and compare the efficacy of Hilo® and Daflon® 500 mg, in the treatment of hemorrhoids. Study Design: It is a multicentric, randomized, comparative clinical trial conducted for the period of 15 days. Place and Duration of Study: Janta Hospital and Maternity Centre, Varanasi; King George Memorial Hospital, Lucknow; Vijan Hospital and Research Centre, Nasik and Santosh Hospital, Bangalore between May 2018 and December 2019. Methodology: 201 patients were screened and 200 patients with hemorrhoids (proctoscopy proven Grade I to III) were randomly assigned to receive either Hilo® capsules (n = 99) or Daflon® 500 mg tablets (n = 101). Assessment of hemorrhoidal symptoms was carried out in all patients on Day 7 and Day 15. Proctoscopic examination was carried out before the start of treatment i.e. on day 0 and at the end of treatment duration i.e. on day 15. Results: The patients treated with Hilo® showed a statistically significant improvement in the clinical symptoms of bleeding, pain, itching, soiling, tenesmus, irritation after defecation and constipation on day 7 and day 15 as compared to baseline. The “mean total symptom score” reduced by 4.55 ± 2.07 vs 3.44 ± 2.00; P < .0001 on day 7 and 7.56 ± 2.40 vs 6.22 ± 2.55; P < .0001 on day 15 in the patients treated with Hilo® and Daflon® respectively. In Hilo® Group, 82.83% of patients assessed that the treatment with Hilo® made them ‘A lot better’ as compared to only 48.51% in Daflon® group. In the Hilo® group 20.2% of patients’ treatment outcome was assessed as ‘Excellent’ by the investigators as compared to only 0.99% of patients in Daflon® group. No major adverse events were reported in the study with the use of either product. Conclusion: Hilo® is found to provide better reduction in clinical symptoms of patients suffering from hemorrhoids as compared to Daflon®.

scholarly journals Effects of Rivastigmine on Memory and Cognition in Multiple Sclerosis

2008 ◽  
Vol 35 (4) ◽  
pp. 476-481 ◽  
Author(s):  
Vahid Shaygannejad ◽  
Mohsen Janghorbani ◽  
Fereshteh Ashtari ◽  
Hamid Afshar Zanjani ◽  
Naser Zakizade
Keyword(s):  
Multiple Sclerosis ◽  
Cognitive Dysfunction ◽  
Clinical Symptoms ◽  
Placebo Response ◽  
Response To Treatment ◽  
Double Blind ◽  
Wechsler Memory Scale ◽  
Memory Score ◽  
The Mean ◽  
To Receive

Background:Cognitive dysfunction is one of the common clinical symptoms in multiple sclerosis (MS), but there is no effective treatment for it.Objective:The aim of this study was to evaluate the effect of rivastigmine in treating memory and cognitive dysfunction in MS.Methods:A single-center double-blind placebo-controlled randomized clinical trial conducted from October 2005 to February 2007. Sixty definite MS patients with cognitive impairment age 16 to 54 years were randomly allocated to receive a 12-week treatment course of either rivastigmine (1.5 mg once a day increment over 4 weeks to 3 mg twice daily) or placebo. Response to treatment was assessed by the Wechsler Memory Scale (WMS) at baseline and 12 weeks after start of therapy.Results:A slight, but significant memory improvement occurred in both groups. Of the 30 patients treated with rivastigmine, the mean (SD) WMS general memory score increased from 60.3 (4.2) at baseline to 64.9 (5.3) at the end of study period (P<0.001). Correspondingly, in the 30 patients treated with placebo, the mean (SD) WMS general memory score increased from 60.5 (4.9) to 64.5 (3.7) (P < 0.001). The average WMS general memory score at the end of trial did not changed between rivastigmine and placebo group (mean difference, 0.4; 95% CI, -2.0, 2.8).Conclusion:No significant differences were seen between rivastigmine and placebo on the mean (SD) WMS general memory score. A larger multicenter study of rivastigmine in MS is warranted in order to more definitely assess the efficacy of this intervention.

scholarly journals Clinical efficacy of nutraceutical diet for cats with clinical signs of cutaneus adverse food reaction (CAFR)

2017 ◽  
Vol 20 (2) ◽  
pp. 269-276 ◽  
Author(s):  
F. Mazzeranghi ◽  
C. Zanotti ◽  
A. Di Cerbo ◽  
J.P. Verstegen ◽  
R. Cocco ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Clinical Signs ◽  
Skin Lesions ◽  
Food Allergies ◽  
Toxic Compounds ◽  
Adverse Food Reaction ◽  
Group A ◽  
The Mean ◽  
To Receive ◽  
Lesion Severity

Abstract Food allergies and food intolerances are clinically difficult to discriminate. Most often, along with cutaneous adverse food reactions or CAFR, they are classified as adverse food reactions, whose causes are numerous, including toxic compounds. Eighteen indoor-housed domestic cats with evident clinical symptoms related to CAFR (drooling, back and neck intense itching, neck eczema, chronic conjunctivitis and stomatitis) involving skin lesions were studied. Cytological evaluations of ear, skin and gingival swabs revealed an increased turnover of keratinocytes while the oxytetracycline ELISA determination showed an unexpected high amount of oxytetracycline in all cats at the first visit. All cats were then randomly assigned to receive a standard (SD group) or a nutraceutical diet (ND group) for 60 days. In the ND group a significant reduction of the mean serum concentration of oxytetracycline, pruritus intensity and skin lesion severity (**p<0.01, ***p<0.001, and ***p<0.001, respectively) was observed after 60 days, and associated with a significant improvement in the clinical picture. Although a direct correlation between oxytetracycline presence within cat sera and CAFR-related symptoms has never been described, this study highlights the benefit of a specific nutraceutical diet supplementation in improving clinical symptoms and skin lesions in cats with CARF.

scholarly journals Effectiveness Of Fiberoptic Phototherapy Compared To Conventional Phototherapy In Treating Hyperbilirubinemia Amongst Term Neonates: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Helvi Ndeshihala Joel ◽  
Deborah Mchaile ◽  
Rune Philemon ◽  
Ronald Mbwasi ◽  
Levina Msuya
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Blue Light ◽  
White Light ◽  
Treatment Duration ◽  
Controlled Trial ◽  
Reduction Rate ◽  
Term Neonates ◽  
Randomized Controlled ◽  
The Mean

Abstract Background: Neonatal jaundice is one of the most common problems in newborns. Effective treatment of jaundice requires therapeutic intervention with phototherapy. Over recent years, several studies reported fiberoptic phototherapy to be less effective than conventional phototherapy in term neonates. Our study aimed to compare the effectiveness of fiberoptic phototherapy with a larger illuminated area and higher irradiance to conventional phototherapy methods. Methods: This was a randomized controlled trial conducted at Kilimanjaro Christian Medical Centre (KCMC). A total of 41 term neonates, less than 7 days of age with unconjugated hyperbilirubinemia were randomized. Thirteen (13) newborns were allocated to receive fiberoptic phototherapy, 13 to blue light conventional phototherapy and 15 to white light conventional phototherapy. Effectiveness was assessed by comparing the duration of phototherapy, bilirubin reduction rate and side effects of treatment. The data was analyzed with the independent t-test.Results: The mean overall bilirubin reduction rate was comparable in the fiberoptic phototherapy group (0.74%/h) and the blue light conventional phototherapy group (0.84%/h), with no statistically significant difference (p-value 0.124). However, white light conventional phototherapy had a significantly lower mean overall bilirubin reduction rate (0.29%/h) as compared to fiberoptic phototherapy (p-value <0.001). The mean treatment duration of phototherapy was 69 h, 68 h and 90 h in the fiberoptic, blue light conventional and white light conventional phototherapy groups respectively. Side effects such as loose stool and skin rash were noted in some participants who received conventional phototherapy. No side effects of treatment were noted in the fiberoptic phototherapy group.Conclusion: The effectiveness of fiberoptic PT and blue light conventional PT were comparable in terms of bilirubin reduction rate and treatment duration, whereas fiberoptic phototherapy was more effective than white light conventional PT, with a significantly lower bilirubin reduction rate and treatment duration. Fiberoptic phototherapy may mitigate side effects caused by conventional phototherapy.Trial registration: The Pan African Clinical Trial Registry, PACTR202004723570110. Registered 22nd April 2020- Retrospectively registered, http://www.pactr.org/

scholarly journals Memantine Augmentation Improves Symptoms in Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder: A Randomized Controlled Trial

2017 ◽  
Vol 51 (06) ◽  
pp. 263-269 ◽  
Author(s):  
Atieh Modarresi ◽  
Mehdi Sayyah ◽  
Setareh Razooghi ◽  
Kaveh Eslami ◽  
Mohammadreza Javadi ◽  
...  
Keyword(s):  
Treatment Response ◽  
Controlled Trial ◽  
Large Body ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Randomized Controlled ◽  
Clinical Benefits ◽  
The Mean ◽  
To Receive

Abstract Introduction There is a large body of evidence on the clinical benefits of augmentation therapy with glutamate-modulating agents, such as memantine in reducing OCD symptoms. Methods A double-blind, placebo-controlled trial was conducted on SRIrefractory OCD patients. Thirty-two patients were randomized to receive either 20 mg/day memantine or placebo augmentation and were visited at baseline and every 4 weeks for 12 weeks. Results were measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Results The Y-BOCS total score was significantly reduced in the memantine group at the end of weeks 8 and 12, while no improvement was observed in the placebo group throughout the trial. A reduction of 40.9% in the mean Y-BOCS total score by week 12 in the memantine group resulted in 73.3% of patients achieving treatment response. The findings showed that a time to effect of 8 weeks was necessary to observe significant improvement in OCD symptoms, while treatment response was only seen after 12 weeks of memantine augmentation. Discussion Memantine is an effective and well-tolerated augmentation in severe OCD patients refractory to SRI monotherapy.

scholarly journals Association of kidney function with effectiveness of procalcitonin-guided antibiotic treatment: a patient-level meta-analysis from randomized controlled trials

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Eva Heilmann ◽  
Claudia Gregoriano ◽  
Yannick Wirz ◽  
Charles-Edouard Luyt ◽  
Michel Wolff ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Kidney Function ◽  
Antibiotic Treatment ◽  
Treatment Duration ◽  
Infection Type ◽  
Meta Analysis ◽  
Standard Of Care ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
To Receive

AbstractObjectivesPatients with impaired kidney function have a significantly slower decrease of procalcitonin (PCT) levels during infection. Our aim was to study PCT-guided antibiotic stewardship and clinical outcomes in patients with impairments of kidney function as assessed by creatinine levels measured upon hospital admission.MethodsWe pooled and analyzed individual data from 15 randomized controlled trials who were randomly assigned to receive antibiotic therapy based on a PCT-algorithms or based on standard of care. We stratified patients on the initial glomerular filtration rate (GFR, ml/min/1.73 m2) in three groups (GFR >90 [chronic kidney disease; CKD 1], GFR 15–89 [CKD 2–4] and GFR<15 [CKD 5]). The main efficacy and safety endpoints were duration of antibiotic treatment and 30-day mortality.ResultsMean duration of antibiotic treatment was significantly shorter in PCT-guided (n=2,492) compared to control patients (n=2,510) (9.5–7.6 days; adjusted difference in days −2.01 [95% CI, −2.45 to −1.58]). CKD 5 patients had overall longer treatment durations, but a 2.5-day reduction in treatment duration was still found in patients receiving in PCT-guided care (11.3 vs. 8.6 days [95% CI −3.59 to −1.40]). There were 397 deaths in 2,492 PCT-group patients (15.9%) compared to 460 deaths in 2,510 control patients (18.3%) (adjusted odds ratio, 0.88 [95% CI 0.78 to 0.98)]. Effects of PCT-guidance on antibiotic treatment duration and mortality were similar in subgroups stratified by infection type and clinical setting (p interaction >0.05).ConclusionsThis individual patient data meta-analysis confirms that the use of PCT in patients with impaired kidney function, as assessed by admission creatinine levels, is associated with shorter antibiotic courses and lower mortality rates.

scholarly journals Comparing the efficacy of 7%, 5% hypertonic saline and 0.9% normal saline in acute bronchiolitis: a randomized controlled trial

2018 ◽  
Vol 7 (5) ◽  
pp. 819
Author(s):  
Adel Ahadi ◽  
Manouchehr Barak ◽  
Fatemeh Amani
Keyword(s):  
Randomized Controlled Trial ◽  
Hypertonic Saline ◽  
Normal Saline ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Study Groups ◽  
Acute Bronchiolitis ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
The Mean

Background: The study aimed to investigate the effect of nebulized 5% and 7% Hypertonic Saline (HS) versus Normal Saline (NS) in acute viral bronchiolitis.Methods: This is a prospective, randomized controlled trial study that has been done on 90 infants presenting with acute bronchiolitis. All infants divided randomly in three equal size and matched groups (n=30). Subjects received 4ml nebulized 5% and 7% HS along with 0.15mg/kg Adrenaline or 4 ml 0.9%NS every 6 hours from enrolment until hospital discharge. For all patients, clinical symptoms such as sputum, wheezing, retraction rate, heart rate, fever, crackle, irritability, week nutrition and breathing were recorded in baseline and length of wheezing, cough, and crackle, length of stay (LOS), fever and sputum based on days in the end of study. Collected data analyzed by statistical methods in SPSS.19.Results: At baseline, study groups were similar in demographic and clinical characteristics. The mean age of all patients was 5.5±3.6 months, and 59 (65.6%) were male. The length of cough and crackle, and the length of LOS in 5% and 7% HS groups was significantly lower than NS group.Conclusions: Among infants admitted to the hospital with viral bronchiolitis, treatment with nebulized 5% HS and 7% HS had significant effect on decreasing clinical symptoms length and LOS when compared with NS.

scholarly journals Undermining during cutaneous wound closure for wounds less than 3 cm in diameter: a randomized split wound comparative effectiveness trial

2021 ◽  
Author(s):  
Jayne Joo ◽  
Aunna Pourang ◽  
Catherine N. Tchanque-Fossuo ◽  
April W. Armstrong ◽  
Danielle M. Tartar ◽  
...  
Keyword(s):  
Comparative Effectiveness ◽  
Wound Closure ◽  
Anatomic Site ◽  
Randomized Controlled ◽  
Scar Assessment ◽  
Significant Difference ◽  
The Mean ◽  
To Receive ◽  
Component Scores

AbstractUndermining is thought to improve wound outcomes; however, randomized controlled data regarding its efficacy are lacking in humans. The objective of this randomized clinical trial was to determine whether undermining low to moderate tension wounds improves scar cosmesis compared to wound closure without undermining. Fifty-four patients, 18 years or older, undergoing primary linear closure of a cutaneous defect with predicted postoperative closure length of ≥ 3 cm on any anatomic site were screened. Four patients were excluded, 50 patients were enrolled, and 48 patients were seen in follow-up. Wounds were divided in half and one side was randomized to receive either no undermining or 2 cm of undermining. The other side received the unselected intervention. Three months, patients and 2 masked observers evaluated each scar using the Patient and Observer Scar Assessment Scale (POSAS). A total of 50 patients [mean (SD) age, 67.6 (11.5) years; 31 (64.6%) male; 48 (100%) white] were enrolled in the study. The mean (SD) sum of the POSAS observer component scores was 12.0 (6.05) for the undermined side and 11.1 (4.68) for the non-undermined side (P = .60). No statistically significant difference was found in the mean (SD) sum of the patient component for the POSAS score between the undermined side [15.9 (9.07)] and the non-undermined side [13.33 (6.20)] at 3 months. For wounds under low to moderate perceived tension, no statistically significant differences in scar outcome or total complications were noted between undermined wound halves and non-undermined halves.Trail Registry: Clinical trials.gov Identifier NCT02289859. https://clinicaltrials.gov/ct2/show/NCT02289859.

scholarly journals Effectiveness Of Fiberoptic Phototherapy Compared To Conventional Phototherapy In Treating Hyperbilirubinemia Amongst Term Neonates: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Helvi Ndeshihala Joel ◽  
Deborah Mchaile ◽  
Rune Philemon ◽  
Ronald Mbwasi ◽  
Levina Msuya
Keyword(s):  
Side Effects ◽  
Blue Light ◽  
White Light ◽  
Treatment Duration ◽  
Controlled Trial ◽  
Reduction Rate ◽  
P Value ◽  
Term Neonates ◽  
Randomized Controlled ◽  
The Mean

Abstract Background: Neonatal jaundice is one of the most common problems in newborns. Effective treatment of jaundice requires therapeutic intervention with phototherapy. Over recent years, several studies reported fiberoptic phototherapy to be less effective than conventional phototherapy in term neonates. Our study aimed to compare the effectiveness of fiberoptic phototherapy with a larger illuminated area and higher irradiance to conventional phototherapy methods. Methods: This was a randomized controlled trial conducted at Kilimanjaro Christian Medical Centre (KCMC). A total of 41 term neonates, less than 7 days of age with unconjugated hyperbilirubinemia were randomized. Thirteen (13) newborns were allocated to receive fiberoptic phototherapy, 13 to blue light conventional phototherapy and 15 to white light conventional phototherapy. Effectiveness was assessed by comparing the duration of phototherapy, bilirubin reduction rate and side effects of treatment. The data was analyzed with the independent t-test. Results: The mean overall bilirubin reduction rate was comparable in the fiberoptic phototherapy group (0.74%/h) and the blue light conventional phototherapy group (0.84%/h), with no statistically significant difference ( p -value 0.124). However, white light conventional phototherapy had a significantly lower mean overall bilirubin reduction rate (0.29%/h) as compared to fiberoptic phototherapy ( p -value <0.001). The mean treatment duration of phototherapy was 69 h, 68 h and 90 h in the fiberoptic, blue light conventional and white light conventional phototherapy groups respectively. Side effects such as loose stool and skin rash were noted in some participants who received conventional phototherapy. No side effects of treatment were noted in the fiberoptic phototherapy group. Conclusion: The effectiveness of fiberoptic PT and blue light conventional PT were comparable in terms of bilirubin reduction rate and treatment duration, whereas fiberoptic phototherapy was more effective than white light conventional PT, with a significantly lower bilirubin reduction rate and treatment duration. Fiberoptic phototherapy may mitigate side effects caused by conventional phototherapy. Trial registration: The Pan African Clinical Trial Registry, PACTR202004723570110. Registered 22 nd April 2020- Retrospectively registered, http://www.pactr.org/

scholarly journals Effect of Sulodexide on Urinary Biomarkers of Kidney Injury in Normoalbuminuric Type 2 Diabetes: A Randomized Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Bancha Satirapoj ◽  
Wisit Kaewput ◽  
Ouppatham Supasyndh ◽  
Prajej Ruangkanchanasetr
Keyword(s):  
Type 2 Diabetes ◽  
Placebo Group ◽  
Primary Outcome ◽  
Early Stage ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Randomized Controlled ◽  
The Mean ◽  
To Receive

Glycosaminoglycans or sulodexide has shown benefits in early experimental diabetic nephropathy (DN) models, but its efficacy in patients with early stage of DN is unknown.Methods. Twenty patients were randomly assigned to the placebo group and another 20 patients were randomly assigned to receive sulodexide 100 mg/day for 14 weeks. Primary outcome was a change of urinary TGF-beta1, albuminuria, and glomerular filtration rate (GFR). All patients had stable metabolic profiles for at least 90 days before randomization.Results. Urinary TGF-beta1 increased significantly in the placebo group but did not change significantly in the sulodexide group. Additionally, the mean change of urine TGF-beta1 in the placebo group was significantly higher than that in the sulodexide group (8.44±9.21versus2.17±6.96 pg/mg Cr,P=0.02). Mean changes of urinary albumin were15.05±30.09 μg/mg Cr (P=0.038) in the placebo group and13.89±32.25 μg/mg Cr (P=0.069) in the sulodexide group. No consistent patterns of side effects were observed.Conclusion. In this 14-week trial, benefits of sulodexide in preventing the increase of urinary TGF-beta1 were observed in patients with normoalbuminuric type 2 diabetes. The study suggests that sulodexide treatment may provide additional renoprotection in early stage DN. This trial is registered withTCTR20140806001.

scholarly journals Comparative outcomes of foot cast and short leg cast in pseudo-Jones avulsion fracture: a single blinded randomized controlled trial

2019 ◽  
Vol 12 (1) ◽  
Author(s):  
Peerapong Piyapittayanun ◽  
Kanakij Mutthakalin ◽  
Alisara Arirachakaran ◽  
Jatupon Kongtharvonskul
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Randomized Controlled ◽  
Metatarsal Bones ◽  
Significant Difference ◽  
Metatarsal Fractures ◽  
The Mean ◽  
Foot Fractures ◽  
To Receive

Abstract Background Fractures of the metatarsal bones account for 35% of all foot fractures. Conservative management of fractures proximal to the metaphyseal-diaphyseal junction of the fifth metatarsal bone (pseudo-Jones) is by protected weight bearing. The methods of protected weight bearing include short-leg casting and splinting (boot cast, Jones’s bandage and elastic bandage). However, currently there is no consensus as to which method is the most suitable. Method We have conducted a randomized controlled trial to compare outcomes of foot casting (FC) and short leg casting (SLC) to assess pain, function and complication outcomes for the treatment of pseudo-jones metatarsal fractures. This single-center, single blind,randomized controlled trial was conducted between 1 June 2016–1 July 2018 at Police General Hospital, Bangkok, Thailand. Result A total of 72 pseudo-jones metatarsal fracture participants were randomly allocated to treatment by foot cast or short leg cast. The primary outcomes were pain VAS, AOFAS and complications measured at 2, 4, 6 and 8 weeks after receiving the treatment. Seventy-two patients (36 paticipants per group) were enrolled to receive either FC or SLC. The mean VAS measured at baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks were 7.36, 1.97, 0.58, 0.17 and 0.08 respectively in the FC group; and 6.09, 2.91, 1.23, 0.37 and 0.11 respectively in the SLC group. The mean AOFAS at baseline, 2, 4, 6 and 8 weeks were 33.60, 68.22, 82.72, 91.75 and 98.11 respectively in the FC group; and 32.60, 60.20, 70.20, 92.24 and 99.13 in the SLC group. The estimated mean difference of pain VAS and AOFAS at 2 weeks and 4 weeks were − 0.94 (95% CI: − 1.53, − 0.34), − 0.65 (95%CI: − 1.24, − 0.05), 8.02 (95%CI: 3.74, 12.10) and 12.52 (95%CI: 8.27, 16.78), which were statistically significantly better in the FC groups when compared to the SLC groups. However, there were no statistically significant difference between the two groups at 6 and 8 weeks. Conclusion This study demonstrated that the application of foot casting can improve pain VAS and AOFAS function at 2 and 4 weeks in the treatment of pseudo-jones metatarsal fractures when compared to short leg casting. However, at 6 and 8 weeks, there were no statistically significantly different between the two groups.

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