Effect of Lactocare® Synbiotic on Disease Severity in Ulcerative Colitis: A Randomized Placebo-Controlled Double-Blind Clinical Trial

BACKGROUND Inflammatory bowel diseases are managed by different methods, which may not be well tolerated because of their side effects. Recently, pro-prebiotics are considered as a supplementary treatment in gastrointestinal diseases. In this study, the effect of Lactocare® (ZistTakhmir Company) was investigated on the disease severity in mild to moderate ulcerative colitis. METHODS In this randomized, double-blind clinical trial (Iranian Registry of Clinical Trials number: IRCT201407271264N5), 60 patients with mild to moderate ulcerative colitis were included. An 8-week trial was carried out comparing Lactocare® as a supplement with standard therapy against placebo. Simple Clinical Colitis Activity Index (SCCAI) was measured at baseline and after 8 weeks. Statistical analysis was performed using paired ttest to assess the temporal changes (before and after the treatment) in the mean of SCCAI in each group. Chi-square test was used to compare the response rates. Odds ratios (OR) and the 95% confidence intervals (95%CI) were also calculated. p values of less than 0.05 were considered significant. RESULTS A significant decreased mean SCCAI was seen in the intervention group (4.56 ± 2.56) vs. placebo group (6.54 ± 2.47) (p < 0.05). Response to treatment was seen in 64.3% of the treatment group vs. 47% in the placebo group (p = 0.18). Response to treatment was observed in 90.9% of patients with ulcerative colitis for more than 5 years compared with 44.4% of the control group (p = 0.01). CONCLUSION Regarding the effectiveness of pre-probiotics in mitigating symptoms in patients with ulcerative colitis, it could be suggested to try pre-probiotics in the standard treatment particularly in those with more than five years ofthe disease.

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Effect of Nebulized Eucalyptus for Preventing Ventilator-Associated Pneumonia in Patients under Mechanical Ventilation: A Randomized Double Blind Clinical Trial

10.21203/rs.1.15/v1 ◽

2018 ◽

Author(s):

HasanAli Karimpour ◽

Behzad Hematpour ◽

Saeed Mohammadi ◽

Javad Aminisaman ◽

Maryam Mirzaei ◽

...

Keyword(s):

Clinical Trial ◽

Intensive Care Unit ◽

Intensive Care ◽

Intervention Group ◽

Control Group ◽

Pulmonary Infections ◽

Double Blind ◽

Double Blind Clinical Trial ◽

And Control ◽

And Staphylococcus Aureus

Abstract Background: Pneumonia caused by the ventilator is the most common acquired infection in the intensive care unit, which increases the morbidity and mortality of the patients. Eucalyptus plant has antiseptic properties. Therefore, the present study investigates the effect of eucalyptus incense on prevention of pneumonia in patients with endotracheal tube in the intensive care unit. Methods: This clinical trial study was performed on 100 patients under ventilation in two intervention and control groups in Imam Reza Hospital, Kermanshah, Iran in 2018. The patients in the intervention group, Eucalyptus solution 2% and in the control group received 10 cc distilled water as an inhaler three times a day. The results of the two groups were compared to the incidence of pulmonary infections based on CPIS criteria and compared with SPSS version 19 software. Results: The incidence of late pneumonia was significantly lower in the intervention group (P=0.02). The onset of pneumonia significantly later in the intervention group than the control group (P=0.01). The prevalence of Klebsiella, Candida albicans, and Staphylococcus aureus was significantly decreased in the intervention group (P=0.02) (P=0.04) (P=0.01). Conclusion: The results of this study showed that eucalyptus inhalation is effective in reducing the incidence of pulmonary infection in patients under ventilation. It is recommended that these products be used to prevent pulmonary infections in these patients.

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Bone Texture Fractal Dimension Analysis of Ultrasound-Treated Bone around Implant Site: A Double-Blind Clinical Trial

International Journal of Dentistry ◽

10.1155/2018/2672659 ◽

2018 ◽

Vol 2018 ◽

pp. 1-10 ◽

Cited By ~ 4

Author(s):

Elaf Akram Abdulhameed ◽

Natheer Hashim Al-Rawi ◽

Asmaa Tahseen Uthman ◽

Ab Rani Samsudin

Keyword(s):

Clinical Trial ◽

Fractal Dimension ◽

Intervention Group ◽

High Specificity ◽

Control Group ◽

Implant Stability ◽

Double Blind ◽

Cutoff Value ◽

Double Blind Clinical Trial ◽

Standard Implant

Objectives. To evaluate the efficacy of bone texture fractal dimension (FD) analysis method in predicting implant stability from intraoral periapical radiographs using two implant protocols. Materials and Methods. A double-blind clinical trial was conducted on 22 subjects who needed dental implants. The participants were randomized into two groups, the control group with standard implant protocol treatment and the intervention group with added low-intensity power ultrasound treatment (LIPUS) besides the standard implant protocol. The FD values of bone density were carried out on the mesial and distal sides of the implant on digital intraoral radiographs using the box-counting method. Both resonance frequency (RF) and fractal dimension (FD) were assessed in three time intervals: after surgery and before and after loading. Results. FD on both the mesial and distal sides serve as very good-to-excellent tests with high validity (ROC area exceeding 0.8) in predicting high implant stability (ISQ ≥ 70). The mesial side measurements were consistently better than the distal side among the intervention groups. The optimum cutoff value for the FD-mesial side that predicts a highly stable implant (ISQ ≥ 70) is ≥1.505. At this optimum cutoff value, the mesial side FD is associated with a perfect sensitivity (100%) and fairly high specificity (86.5%). Conclusion. The FD analysis could be recommended as an adjunctive quantitative method in prediction of the implant stability with very high sensitivity and specificity. This trial is registered with ISRCTN72648040.

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Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽

10.1136/bmjopen-2020-041958 ◽

2020 ◽

Vol 10 (10) ◽

pp. e041958

Author(s):

Nirmani Yasara ◽

Nethmi Wickramarathne ◽

Chamila Mettananda ◽

Aresha Manamperi ◽

Anuja Premawardhena ◽

...

Keyword(s):

Clinical Trial ◽

Sri Lanka ◽

Intervention Group ◽

Primary Outcome Measure ◽

Control Group ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Scientific Publications ◽

Double Blind ◽

Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

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Value of Whole-Body Washing With Chlorhexidine for the Eradication of Methicillin-ResistantStaphylococcus aureus:A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

Infection Control and Hospital Epidemiology ◽

10.1086/519929 ◽

2007 ◽

Vol 28 (9) ◽

pp. 1036-1043 ◽

Cited By ~ 88

Author(s):

C. Wendt ◽

S. Schinke ◽

M. Württemberger ◽

K. Oberdorfer ◽

O. Bock-Hensley ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Treatment Group ◽

Solution Treatment ◽

University Hospital ◽

Whole Body ◽

Double Blind ◽

Antiseptic Solution ◽

Double Blind Clinical Trial ◽

Double Blinded

Background.Whole-body washing with antiseptic solution has been widely used as part of eradication treatment for colonization with methicillin-resistantStaphylococcus aureus(MRSA), but evidence for the effectiveness of this measure is limited.Objective.To study the efficacy of whole-body washing with chlorhexidine for the control of MRSA.Design.Randomized, placebo-controlled, double-blinded clinical trial.Setting.University Hospital of Heidelberg and surrounding nursing homes.Patients.MRSA carriers who were not treated concurrently with antibiotics effective against MRSA were eligible for the study.Intervention.Five days of whole-body washing with either 4% chlorhexidine solution (treatment group) or with a placebo solution. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9, and 30 days after treatment with swab samples taken from several body sites.Results.Of 114 patients enrolled in the study (56 in the treatment group and 58 in the placebo group), 11 did not finish treatment (8 from the treatment group and 3 from the placebo group [P= .02]). At baseline, the groups did not differ with regard to age, sex, underlying condition, site of MRSA colonization, or history of MRSA eradication treatment. Eleven patients were MRSA-free 30 days after treatment (4 from the treatment group and 7 from the placebo group [P= .47]). Only groin-area colonization was significantly better eradicated by the use of chlorhexidine. The best predictor for total eradication was a low number of body sites positive for MRSA. Adverse effects were significantly more frequent in the treatment group than in the placebo group (any symptom, 71% vs 33%) but were reversible in most cases.Conclusion.Whole-body washing can reduce skin colonization, but it appears necessary to extend eradication measures to the gastrointestinal tract, wounds, and/or other colonized body sites if complete eradication is the goal.Trial Registration.ClinicalTrials.gov identifier: NCT00266448.

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The efficacy of trimethoprim-sulfamethoxazole treatment in children with acute bloody diarrhea

Paediatrica Indonesiana ◽

10.14238/pi47.1.2007.17-20 ◽

2007 ◽

Vol 47 (1) ◽

pp. 17

Author(s):

Selvi Nafianti ◽

Oke R. Ramayani ◽

Dedy G. Daulay ◽

Supriatmo Supriatmo ◽

Berlian Hasibuan ◽

...

Keyword(s):

Clinical Trial ◽

Developing Countries ◽

Placebo Group ◽

Campylobacter Jejuni ◽

Bloody Diarrhea ◽

Fecal Analysis ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Stool Analysis

Background The etiologies of bloody diarrhea are shigella,amoeba, enterocolitis, trichuriasis, and other causes i.e, EIEC,Campylobacter jejuni or rotavirus. In developing countries,trimetroprim-sulfamethoxazole (TMP-SMP) is effective in 80%of children with bloody diarrhea.Objective To determine the efficacy of trimethoprim-sulfa-methoxazole (TMP-SMX) treatment in children with acute bloodydiarrhea.Methods A randomized double blind clinical trial was conductedin Adam Malik Hospital and Dr. Pirngadi Hospital Medan duringSeptember 2003-March 2004. Children aged 2-24 months oldwith diagnosis of acute bloody diarrhea were randomized into twogroups to either receive TMP-SMX or placebo for 5 days.Microscopic fecal analysis was performed on the first, second,fifth and twelfth day, and the results were compared.Results A total of 68 children consisted of 48 (71%) boys and 20(29%) girls were enrolled. Each group had 34 participants.Analysis of the first day showed leukocyte and erythrocyte in thestool specimens, which were all absent on the twelfth day in bothgroups. There was no difference in stool analysis between TMP-SMX and placebo group in day two (P=0.758), day five (P=0.341)and day twelve. Diarrhea duration in TMP-SMX and placebogroup was 7.18 days and 6.65 days, respectively. This differentwas statistically not significant (P=0.385).Conclusion There is no difference in the efficacy of trimethoprim-sulfamethoxazole treatment compared to placebo in children withacute bloody diarrhea.

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Results of a randomized double-blind clinical trial of Shugan-liangxue prescription for relieving hot flashes in breast cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.9086 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 9086-9086

Author(s):

P. Li ◽

H. Sun

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Hot Flashes ◽

Oral Solution ◽

Endocrine Treatment ◽

Common Side Effect ◽

Breast Cancer Patients ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Report Symptom

9086 Background: Hot flashes are a common side effect for BC pts during endocrine treatment. An oral solution of TCM is prescribed for the purpose of clearing heat and cooling blood. There is no phytoestrogen in TCM compound and each herbal with luciferase activity detection. 66 patients involved in the study from October 2004 to November 2006. Methods: A placebo controlled randomized double blind clinical trial was designed. The endpoint is hot flashes relieving. The second point is improving the sleeping disturbance. Sample numbers designed by statistician. Daily average of hot flashes was recorded by pts for a week as a baseline. The age, ER and PR status, hot flashes scores were distributed approximately equal between the two groups. Hot flashes scores were evaluated according to Kupperman menopausal index (KI). TCM or placebo liquid (100ml) was administrated orally three times a day for 3 weeks by a randomized envelope method. Results: Total 66 patients were evaluated. For hot flashes in placebo group 69.7%(23/33) no change, 30.3%(10/33) relieved, no pts report symptom disappear. There are 42.4%(14/33) hot flashes no change, 42.4 % (14/33) relieved, 15.2 %(5/33) hot flashes disappearance in TCM group (P=0.006). For sleeping disturbance in placebo group is 60.6%(20/33) no change, 39.4%(13/33) sleep improvement. In TCM group is 36.4%(12/33) no change, 63.6%(21/33) sleep improvement (P=0.049). Conclusions: According to the principle of TCM treatment hot flashes and ER and/or PR positive BC endocrine treatment characteristic, the TCM prescription is effective in alleviating tamoxifen-induced hot flashes and sleep disturbance while there is no phytoestrogen. No significant financial relationships to disclose.

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Cannabis is associated with clinical but not endoscopic remission in ulcerative colitis: A randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0246871 ◽

2021 ◽

Vol 16 (2) ◽

pp. e0246871

Author(s):

Timna Naftali ◽

Lihi Bar-Lev Schleider ◽

Fabiana Scklerovsky Benjaminov ◽

Fred Meir Konikoff ◽

Shelly Tartakover Matalon ◽

...

Keyword(s):

Quality Of Life ◽

Ulcerative Colitis ◽

Placebo Group ◽

Activity Index ◽

Controlled Trial ◽

Clinical Effects ◽

Short Term Treatment ◽

Double Blind ◽

Endoscopic Score

Background Cannabis is often used by patients with ulcerative colitis, but controlled studies are few. We aimed to assess the effect of cannabis in improving clinical and inflammatory outcomes in ulcerative colitis patients. Methods In a double-blind, randomized, placebo-controlled trial, patients received either cigarettes containing 0.5 g of dried cannabis flowers with80mgTetrahydrocannabinol (THC)or placebo cigarettes for 8 weeks. Parameters of disease including Lichtiger disease activity index, C reactive protein (CRP), calprotectin, Mayo endoscopic score and quality of life (QOL) were assessed before, during and after treatment. Results The study included 32 patients. Mean age was 30 years, 14 (43%) females. Lichtiger index improved in the cannabis group from 10.9 (IQR 9–14) to5 (IQR 1–7), (p<0.000), and in the placebo group from 11 (IQR 9–13) to 8 (IQR 7–10)(p = 0.15, p between groups 0.001). QOL improved in the cannabis group from 77±4 to 98±20 (p = 0.000) but not in the placebo group (78±3 at week 0 and 78±17 at week 8;p = 0.459; p between groups 0.007). Mayo endoscopic score changed in the cannabis group from 2.13±1 to 1.25±2 (p = 0.015) and in the placebo group from 2.15±1to 1.69±1 (p = 0.367, p between groups 0.17). Conclusion Short term treatment with THC rich cannabis induced clinical remission and improved quality of life in patients with mild to moderately active ulcerative colitis. However, these beneficial clinical effects were not associated with significant anti-inflammatory improvement in the Mayo endoscopic score or laboratory markers for inflammation.(clinicaltrials.gov NCT01040910).

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Comparing the Efficacy of Topical Metformin and Placebo in the Treatment of Melasma: A Randomized, Double-blind, Clinical Trial

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v30i430276 ◽

2019 ◽

pp. 1-8

Author(s):

Mohammad Ali Mapar ◽

Ali Asghar Hemmati ◽

Ghazal Namdari

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Double Blind ◽

Laboratory Findings ◽

Double Blind Clinical Trial ◽

Metformin Group ◽

Significant Difference ◽

Before And After ◽

P 16 ◽

The Mean

Introduction: Generally affecting women, melasma is the acquired disorder of hyperpigmentation, and researches are still ongoing to find an effective, fast, and low-side-effect drug treating this disease. The present study is aimed at comparing the efficacy of topical metformin and placebo in the treatment of melasma. Methods: Sixty patients with melasma were treated in placebo and topical metformin recipient groups in a double-blind clinical trial. In addition to the demographic and laboratory findings of patients before and after the intervention, the MASI Score of patients in weeks 0, 4, 8, and 12 of the study and then one month after the study were analyzed using SPSS version 20 software. Results: The mean age of the studied patients was 35.25 ± 7.11 years. No significant difference was observed between the phenotypes (P= .49) and the type of melasma (P= .63) in the two groups. The mean MASI score of patients at the time of being included in the study in the placebo group was 10.47 ± 3.08; and in the metformin group, it was 11.93 ± 4.64 (P = .16). Compared to the beginning of the study, the MASI scores were significantly decreased in both groups of placebo (P = .00) and metformin (P = .00) one month after the end of the study; nevertheless, no statistically significant difference was observed between the MASI Scores of two groups in any of the study periods (P > .05). Conclusion: The results of the present study showed that metformin cream significantly declines the patients’ MASI score and does not have any effect on patients’ laboratory markers. Of course, no significant difference was observed between the MASI scores of the patients receiving metformin and the placebo group; however, the MASI score decrease trend continued until the 12th week; while in the placebo group, no significant decrease was seen after eight weeks.

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The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: A randomised placebo-controlled double-blind clinical trial

10.21203/rs.3.rs-40899/v3 ◽

2020 ◽

Author(s):

Naser Gharebaghi ◽

Rahim Nejadrahim ◽

Seyed Jalil Mousavi ◽

Seyyed-Reza Sadat-Ebrahimi ◽

Reza Hajizadeh

Keyword(s):

Clinical Trial ◽

Mortality Rate ◽

Hospital Mortality ◽

Intravenous Immunoglobulin ◽

Initial Treatment ◽

Control Group ◽

Double Blind ◽

Reduce Mortality Rate ◽

Double Blind Clinical Trial ◽

Laboratory Test Results

Abstract Background: Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.Methods: This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for three days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded.Results: Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042).Conclusions: Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment.Trial registration: A study protocol was registered at the Iranian Registry of Clinical Trials (www.IRCT.ir), number IRCT20200501047259N1. It was registered retrospectively on May 17th, 2020.

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