scholarly journals Comparison of the effect of polyethylene glycol and simultaneous administration of polyethylene glycol with probiotics in the treatment of chronic functional constipation: a clinical trial

2020 ◽  
Vol 22 (3) ◽  
pp. 135-140
Author(s):  
Karamali Kasiri ◽  
Morteza Sedehi ◽  
Sheida Mortazavi
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Polyethylene Glycol ◽  
Lactobacillus Rhamnosus ◽  
Functional Constipation ◽  
Water Soluble ◽  
Fecal Excretion ◽  
Simultaneous Administration ◽  
Double Blind ◽  
Significant Difference

Background and aims: Constipation is one of the most common issues in pediatrics. The aim of this study was to compare the effect of polyethylene glycol and the simultaneous administration of polyethylene glycol along with probiotics in the treatment of chronic functional constipation. Materials and Methods: In this randomized double-blind clinical trial, 150 children with chronic functional constipation referred to Imam Ali Clinic affiliated with Shahrekord University of Medical Sciences from 2017 to 2018 were included. The first group (A) consumed 1 g/ kg of body weight per day of water-soluble polyethylene glycol powder and the second group (B) consumed a probiotic powder and 1 g/kg of body weight of the water-soluble polyethylene glycol powder daily. In weeks 0, 1, and 2, questionnaires were filled out by the parents of the children and the data were analyzed. Results: The results showed that there was no significant difference in any of the variables between groups A and B (P=0.07) including the frequency of fecal excretion in week 1 (77% and 71%) and week 2 (4% and 5.4%) and stool consistency in week 1 (4% and 6.7%) and week 2 (86.7% and 92%). Moreover, there was no significant difference between groups A and B in any of the variables frequency of painful excretion in week 1 (74% and 73%, respectively) and week 2 (5.3% and 4%, respectively), frequency of abdominal pain in week 1 (61.3% and 49.3%, respectively) and week 2 (4% and 5.3%, respectively), and the frequency of fecal incontinence in week 1 (22.77% and 18.7%, respectively) and week 2 (6.7% and 1.3%) (P>0.05, respectively). Conclusion: Our results indicated that the administration of probiotic supplement (Lactobacillus Rhamnosus, Lactobacillus acidophilus, Lactobacillous Bulgaricus) has no effect on the improvement of symptoms in children with chronic constipation.

scholarly journals Single Dose or Divided Dose of Polyethylene Glycol in Treatment of Pediatric Functional Constipation: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Heidar Safarpour ◽  
Mohammad Hadi Imanieh ◽  
naser honar ◽  
sajad hekmati ◽  
Naeimehossadat Asmarian
Keyword(s):  
Clinical Trial ◽  
Single Dose ◽  
Polyethylene Glycol ◽  
Randomized Clinical Trial ◽  
Divided Dose ◽  
Functional Constipation ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Abstract BackgroundThis study aimed to compare different regimens of Polyethylene Glycol (PEG, single dose vs. divided dose) in the treatment of functional constipation among children aged 4-15 years.Materials and MethodsThis double-blind randomized clinical trial was conducted on the children (4-15 years old) with functional constipation who were visited in an outpatient pediatric clinic affiliated to Shiraz University of Medical Sciences between February and July 2021. Among the120 eligible patients, 80 ones who met the inclusion criteria were recruited. The patients were divided into two parallel groups; the children who received single-dose PEG (group A) and those who received PEG in divided doses (group B). The study was performed during 12 weeks and follow-up visits were scheduled at 1, 3, 6, and 12 weeks after enrollment. The outcomes were measured using the Bristol Stool Form Scale (BSFS).ResultsThe study was performed on 78 cases including 45 boys (57.7%) and 33 girls (42.3%) with the mean age of 5.52±1.79 years. After 12 weeks, a significant difference was observed between groups A and B regarding the mean of BSFS (4.94±0.52 vs. 4.50±0.88, p=0.008). However, no significant difference was observed between the two groups regarding the number of defecation times during the study. The detected complications included mild abdominal pain in eight children in group A (5.3%), fecal incontinency in six children in group B (3.8%), and painful defecation in six children in group B (3.8%).ConclusionThis study confirmed that the administration of the single dose (0.4 g/kg) of PEG early in the morning was more effective, well tolerated, and accompanied by fewer complications compared to the divided dose.

scholarly journals Efficacy of fructooligosaccharide versus placebo for treatment of acute diarrhea in children: A double-blind randomized clinical trial

2016 ◽  
Vol 45 (2) ◽  
pp. 65
Author(s):  
Reni Suryanty ◽  
Supriatmo Supriatmo ◽  
Berlian Hasibuan ◽  
Atan Baas Sinuhaji
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Placebo Group ◽  
Randomized Clinical Trial ◽  
Outpatient Clinic ◽  
Acute Diarrhea ◽  
Pediatric Patients ◽  
Inclusion Criteria ◽  
Double Blind ◽  
Significant Difference

Objective To compare the efficacy of fructooligosaccharide (FOS)versus placebo in pediatric patients with acute diarrhea with re-gard to duration and frequency of diarrhea and the volume andconsistency of the stools.Methods This double-blind randomized clinical trial was carriedout from July to November 2003 in the pediatric intensive careunit, outpatient clinic, and pediatric ward of Adam Malik Hospitaland Pirngadi Hospital, Medan. Subjects were children and infantsaged 4 to 24 months suffering from acute diarrhea without dehy-dration or with mild to moderate dehydration whose parents gaveconsent. Children included in this trial received tablets of either600 mg FOS or 761 mg fructulin as placebo. Patients with mild tomoderate dehydration were initially rehydrated according to theWHO protocol. Afterwards, 10 tablets of FOS or placebo were givento each subject to be taken twice daily. In subjects without dehy-dration, the tablets were given by their parents. Daily follow-upwas performed, in which body weight, temperature, duration andfrequency of diarrhea, and the volume and consistency of stoolswere recorded. For outpatients, home visits were made.Results Out of 142 children who met inclusion criteria, 135 com-pleted the study. These consisted of 68 children in the FOS groupand 67 in the placebo group. Subjects were mostly <12 months ofage (57.0%), male (57.8%), and moderately malnourished (34.1%).There was no statistically significant difference between both groupsin the duration and frequency of diarrhea and the volume and con-sistency of stools (P>0.05).Conclusion There is no effect of the administration of FOS assupplemental therapy on the duration and frequency of diarrheaand on the volume and consistency of stools in children with acutediarrhea

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

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
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.

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

Solumedrol Treatment for Severe Sepsis in Humans with a Blunted Adrenocorticotropic Hormone-Cortisol Response: A Prospective Randomized Double-Blind Placebo-Controlled Pilot Clinical Trial

2021 ◽  
pp. 088506662110388
Author(s):  
Divya Birudaraju ◽  
Sajad Hamal ◽  
John A. Tayek
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Adrenocorticotropic Hormone ◽  
Serum Cortisol ◽  
High Dose ◽  
Cortisol Response ◽  
Acth Stimulation ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive

Purpose To test the benefits of Solumedrol treatment in sepsis patients with a blunted adrenocorticotropic hormone (ACTH)-cortisol response (delta <13 µg/dL) with regard to the number of days on ventilator, days on intravenous blood pressure support, length of time in an intensive care unit (ICU), 14-day mortality, and 28-day mortality. The trial was prospective, randomized, and double-blind. As part of a larger sepsis trial, 54 patients with sepsis had an intravenous ACTH stimulation test using 250 µg of ACTH, and serum cortisol was measured at times 0, 30, and 60 min. Eleven patients failed to increase their cortisol concentration above 19.9 µg/dL and were excluded from the clinical trial as they were considered to have adrenal insufficiency. The remaining 43 patients had a baseline cortisol of 32 ± 1 µg/dL increased to 38 ± 3 µg/dL at 30 min and 40 ± 3 at 60 min. All cortisol responses were <12.9 µg/dL between time 0 and time 60, which is defined as a blunted cortisol response to intravenous ACTH administration. Twenty-one were randomized to receive 20 mg of intravenous Solumedrol and 22 were randomized to receive a matching placebo every 8 h for 7-days. There was no significant difference between the two randomized groups. Data analysis was carried out bya two-tailed test and P < .05 as significant. Results Results: The mean age was 51 ± 2 (mean ± SEM) with 61% female. Groups were well matched with regard to APACHE III score in Solumedrol versus placebo (59 ± 6 vs 59 ± 6), white blood cell count (18.8 ± 2.2 vs 18.6 ± 2.6), and incidence of bacteremia (29 vs 39%). The 28-day mortality rate was reduced in the Solumedrol treated arm (43 ± 11 vs 73 ± 10%; P < .05). There was no change in days in ICU, days on blood pressure agents, or days on ventilator. Seven days of high-dose intravenous Solumedrol treatment (20 mg every 8 h) in patients with a blunted cortisol response to ACTH was associated with an improved 28-day survival. This small study suggests that an inability to increase endogenous cortisol production in patients with sepsis who are then provided steroid treatment could improve survival.

scholarly journals A comparison of the effect of dexamethasone and pethidine for prevention of shivering after spinal anesthesia in caesarean section: randomization clinical trial

2018 ◽  
Vol 5 (9) ◽  
pp. 2646-2650 ◽  
Author(s):  
Hamideh Gholami ◽  
Yousef Moradi ◽  
Zaher Khazaei ◽  
Shahrzad Tehrani
Keyword(s):  
Clinical Trial ◽  
Caesarean Section ◽  
Spinal Anesthesia ◽  
Normal Saline ◽  
Saline Group ◽  
Elective Cesarean Section ◽  
Double Blind ◽  
Dexamethasone Group ◽  
Postanesthetic Shivering ◽  
Significant Difference

Background: Postanesthetic shivering is one of the most common complications and problems after operations. Medications and drugs can be used to prevent postanesthetic shivering. The aim of this study is to compare the effects of Dexamethasone and Pethidine in preventing postanesthetic shivering after spinal anesthesia in Iranian women undergoing caesarean section. Method: This double-blind randomized clinical trial was performed in 66 pregnant women who were referred to Ayatollah Moosavi Hospital in Zanjan, Iran for elective cesarean section, from December 2011 to November 2012. All participants who have ASA I-II were randomly classified into three groups: Dexamethasone receivers (Group A), Pethidine receivers (Group B), and Normal Saline receivers (Group C). Data were collected and analyzed using SPSS16 software. IRCT registration number of this study is IRCT201112198469N1. Conclusion: Although statistically there was no significant difference between the three groups of Dexamethasone, Pethidine and Normal Saline receivers regarding shivering reduction; clinical complication rate in Dexamethasone group was lower comparedto Pethidine and Normal Saline groups. Results: There was no significant difference between three groups regarding shivering reduction. There were 11 (72.5%) trembling cases in Normal Saline group, 6 cases (27.3%) in Dexamethasone group, and 12 cases (54.5%) in Pethidine group.

scholarly journals Propranolol versus topiramate in prophylaxis of migraines among children and adolescents: a randomized, double-blind clinical trial

2017 ◽  
Vol 5 (10) ◽  
pp. 4307 ◽  
Author(s):  
Ramakant Yadav ◽  
S. K. Shukla
Keyword(s):  
Clinical Trial ◽  
Children And Adolescents ◽  
International Headache Society ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Relative Reduction ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
Propranolol Group

Background: Migraine is a common health problem in children and adolescents. This study compares the efficacy and safety of propranolol and topiramate in preventing migraine among children and adolescents.Methods: Seventy-six patients (10-18 years of age) with migraine without auras defined by the 2004 International Headache society criteria were included in a prospective double blind clinical trial were allocated to receive propranolol (0.5-2mg/kg per day) or topiramate (1-2mg/kg per day). The primary outcome measure was reduction in 50 % or more headache days in comparison to baseline headache frequency per month. Secondary outcome measures were headache related disability, migraine intensity and duration. Efficacy measures were recorded at the baseline and at 12 weeks of prophylactic treatment.Results: In this study total of 76 patients with mean age of 12.43 years were evaluated, 40 in the propranolol group and 36 in the topiramate group. At the 12-week, the percentage of patients who had a relative reduction of 50% or more in the number of headache days were 67.5% patients in the propranolol group and 75.0% patients in the topiramate group. The monthly migraine frequency, headache related disability, intensity and duration were significantly decreased in both the propranolol and topiramate groups when compared to the baseline. No significant difference was observed between these two groups in term of reduction of frequency, headache related disability, severity and duration of attack. Fatigue, hypotension and exercise induced asthma were main side effects in propranolol group and weight loss, fatigue and loss of appetite, paresthesias in topiramate group.Conclusions: Propranolol and topiramate were found effective and safe for the prevention of paediatric migraines.

scholarly journals The effects of steamed ginger ethanolic extract on weight and body fat loss: a randomized, double-blind, placebo-controlled clinical trial

2019 ◽  
Vol 29 (2) ◽  
pp. 265-273 ◽  
Author(s):  
Soo-Hyun Park ◽  
Su-Jin Jung ◽  
Eun-Kyung Choi ◽  
Ki-Chan Ha ◽  
Hyang-Im Baek ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Body Mass Index ◽  
Body Weight ◽  
Body Mass ◽  
Body Fat ◽  
Ethanolic Extract ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Fat Loss

Abstract Steamed ginger ethanolic extract (SGE) is a product with a high 6-shogaol contents and is thought to be more potent than other ginger products. We conducted a 12-week, randomized, double-blind, placebo-controlled clinical trial to determine the effects of SGE on weight and body fat loss. Eighty healthy obese participants were recruited and randomly divided into the SGE and placebo groups. The outcome measures comprised indicators of efficacy (body weight, body mass index, body composition, and blood markers) and safety. Following the supplementation period, mean body weight, body mass index, and body fat level were significantly lower in the SGE group than in the placebo group. No clinically significant changes were observed for any safety parameter. These results suggest that SGE is a potent anti-obesity agent that does not cause significant side effects. Therefore, SGE supplementation combined with lifestyle modification could be effective in the management of body weight and fat mass.

scholarly journals A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

Sign in / Sign up

Export Citation Format

Share Document