scholarly journals Acetaminophen Induced Transient Hypothermia in Pediatrics Population Undergoing General Anesthesia; a Double Blinded Randomized Controlled Clinical Trial

2021 ◽  
Vol 6 (2) ◽  
pp. 1-6
Author(s):  
Kafrouni HF
Keyword(s):  
Clinical Trial ◽  
General Anesthesia ◽  
Core Temperature ◽  
Core Body Temperature ◽  
Pediatric Population ◽  
Temperature Drop ◽  
Critical Time ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Double Blinded

Background: Perioperative hypothermia has been strongly associated with poor outcomes in children undergoing general anesthesia. Methods: This study consisted of a monocentric, block randomized, double blinded, placebo-controlled clinical trial over a period of 3 months at a tertiary referral center. Non-febrile patients with no significant medical history younger than 3 years and having surgery for a minimum duration of one hour under General Anesthesia were chosen. Thirty minutes prior to emergence, patients received either IV Acetaminophen (Group P) or a placebo solution of normal saline (Group N). The temperature was recorded at T0, T15, T30, T45 and T60 intervals. Results: 60 out of 84 patients were enrolled, the sample consisted of 58.3% (n=35) males and 41.7% (n=25) females with a mean age 1.16 ± 0.92 years. When using a t test to compare the mean core temperature, at a 95% Confidence Interval and ±=0.05, data showed that in Group P (35.52 ±0.68 oC < 36°C) and in Group N (36.07 ±0.71 oC > 36°C) were significantly different at T30 (p<0.005). A similar significance was observed at T45 yet not at T60. Conclusion: Acetaminophen seems to have induced a significant transient hypothermia at T30 in the pediatric population, which coincides in this study with the critical time of emergence. At T60, no significant difference was observed, suggesting that patients’ core body temperature values returned to normality. Therefore, it is recommended to administer Acetaminophen at least 60 minutes prior to emergence to avoid a core temperature drop during this critical phase.

scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. e1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Common Cold ◽  
Primary Outcome Measure ◽  
Drug Group ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Preventive Efficacy ◽  
Double Blinded ◽  
Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]  

scholarly journals Synbiotics and Treatment of Asthma: A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial

2019 ◽  
Vol 8 ◽  
pp. 1350
Author(s):  
Maryam Hassanzad ◽  
Keyvan Maleki Mostashari ◽  
Hosseinali Ghaffaripour ◽  
Habib Emami ◽  
Samane Rahimi limouei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Positive Effects ◽  
Outpatient Visits ◽  
Significant Difference ◽  
Asthma In Children ◽  
Double Blinded ◽  
Experimental Group

Background: We examined the efficiency and safety of a specific synbiotic compound, brand name Kidilact®, in the treatment of asthma in children 12 years of age or younger. Materials and Methods: This double-blinded, randomized, placebo-controlled clinical trial was conducted in Tehran, Iran, from May 22, 2016, to May 21, 2017. One hundred children, 12 years of age or younger, who suffered from mild to moderate asthma were recruited in this study. The subjects were randomly divided into two groups; the experimental group received a sachet of Kidilact®, and the control group received a sachet of placebo once a day for six months. Both groups were compared in terms of the frequency of asthma attacks that were severe enough to require administration of fast-acting medications, the number of outpatient visits for asthma-related problems, and the frequency of hospitalization due to exacerbated symptoms of asthma. Results: There were fewer complaints of drug-induced side effects, e.g., vomiting, headache, stomachache, and diarrhea, exacerbated cough, and constipation in the experimental group than in the control group. Overall, a significantly greater number of participants in the experimental group were satisfied with the therapeutic intervention than those in the control group, as verified by the participants and their parents/guardians self-report. There was no significant difference between both groups in the frequency of asthma attacks and hospitalization due to exacerbated symptoms of asthma. The only significant difference between both groups was the count of outpatient visits. While the control group made 55 outpatient visits to the hospital, participants in the experimental group visited the hospital only 19 times (P=0.001). Conclusion: Results of our study indicates that synbiotic compound Kidilact® generally alleviates the symptoms of asthma in children of 12 years of age or younger, resulting in less frequent outpatient visits to the hospital due to asthma-related problems while rarely causing any side effects. Due to ease of use, the rarity of side effects, and their indirect positive effects on quality of life of asthmatic patients, we recommend that synbiotics be incorporated in regular treatment and management of children with asthma. [GMJ.2019;8:e1350]

scholarly journals The Effect of Lactobacillus acidophilus YT1 (MENOLACTO) on Improving Menopausal Symptoms: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 (7) ◽  
pp. 2173
Author(s):  
Eun Yeong Lim ◽  
So-Young Lee ◽  
Hee Soon Shin ◽  
Jaekwang Lee ◽  
Young-Do Nam ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Lactobacillus Acidophilus ◽  
Menopausal Symptoms ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Sexual Symptoms ◽  
Significant Difference ◽  
Double Blinded

This study evaluated the efficacy of Lactobacillus acidophilus YT1 (MENOLACTO) for alleviating menopausal symptoms. This study was a multi-center, randomized, double-blinded, placebo-controlled clinical trial involving female subjects (ages: 40–60 years) with menopausal symptoms and a Kupperman index (KMI) score ≥ 20. Subjects were administered 1 × 108 CFU/day MENOLACTO or placebo, with the primary endpoint being total KMI score, and the effect of secondary endpoints on alleviating menopausal symptoms according to individual categories of the modified KMI, as well as a quality of life questionnaire (MENQOL questionnaire). After 12 weeks, total KMI scores decreased significantly, demonstrating improved menopausal symptoms relative to placebo along with improved modified KMI scores. Additionally, quality of life, according to the MENQOL questionnaire, significantly improved in all four symptoms—physical, psychosocial, vasomotor, and sexual symptoms. Moreover, we observed no significant difference between the two groups or significant changes in blood follicle-stimulating hormone and estradiol levels or endometrial thickness. These results demonstrated that MENOLACTO alleviated menopausal symptoms without notable side effects and improved quality of life, suggesting its efficacy as an alternative supplement to alleviate menopausal symptoms in women ineligible for hormonal therapy.

scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. 1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Common Cold ◽  
Primary Outcome Measure ◽  
Drug Group ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Preventive Efficacy ◽  
Double Blinded ◽  
Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]

scholarly journals Efficacy of Topical Tranexamic Acid in Reducing Blood Loss after Laminectomy and Posterolateral Fusion of the Spine: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2021 ◽  
Author(s):  
Moslem Shakeri ◽  
Mansour Valaie ◽  
Farhad Mirzaei ◽  
Ramyar Hariri ◽  
Ehsan Jangholi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tranexamic Acid ◽  
Posterolateral Fusion ◽  
Controlled Clinical Trial ◽  
Bleeding Rate ◽  
Intergroup Comparison ◽  
Significant Difference ◽  
The Mean ◽  
Double Blinded ◽  
Topical Tranexamic Acid

Background: Multi-level spine surgeries are associated with high bleeding during and after surgery. A majority of studies have previously evaluated the effect of tranexamic acid (TXA) in reducing bleeding with a focus on intravenous (IV) administration. The aim of the study was to evaluate the efficacy of topical TXA in decreasing bleeding after laminectomy and spinal fusion. Methods: In this randomized, double-blinded, placebo-controlled clinical trial, 80 patients were enrolled from January 2017 to January 2019. The patients were eligible for laminectomy (2 or more levels) and posterolateral fusion with a pedicle screw. Patients were randomly divided into two equal groups; single-dose TXA (1 g/50 ml) and normal saline. Intergroup comparison was performed for the amount of bleeding during and after surgery, received packed cells, and the number of hospitalization days. Results: The mean age of the patients was 55.51 ± 10.27 years, and 50 of them were women. 18 and 20 patients in control and TXA groups had intraoperative bleeding more than 400 ml, respectively (P ˃ 0.05). The only significant difference was observed in the first and second 12 hours, and total bleeding after surgery in patients who had bleeding above 400 ml (P = 0.011, P = 0.039, P = 0.015, respectively). Conclusion: The application of topical TXA was effective in patients with high amount of hemorrhage during spine surgery for reducing the bleeding rate in the first and second 12 hours, as well as the mean total bleeding rate after surgery. It had no significant effect on total intraoperative hemorrhage, total packed cells, and total hospitalization length.  

Liraglutide as an Additional Treatment to Insulin in Patients with Type 1 Diabetes Mellitus—A 52-Week Randomized Double-Blinded Placebo-Controlled Clinical Trial

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 3-LB ◽  
Author(s):  
PARESH DANDONA ◽  
HUSAM GHANIM ◽  
NITESH D. KUHADIYA ◽  
TANVI SHAH ◽  
JEANNE M. HEJNA ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Trial ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Additional Treatment ◽  
Controlled Clinical Trial ◽  
Double Blinded

scholarly journals Administration of Apple Polyphenol Supplements for Skin Conditions in Healthy Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1071
Author(s):  
Toshihiko Shoji ◽  
Saeko Masumoto ◽  
Nina Moriichi ◽  
Yasuyuki Ohtake ◽  
Tomomasa Kanda
Keyword(s):  
Clinical Trial ◽  
Uv Irradiation ◽  
Skin Pigmentation ◽  
Controlled Clinical Trial ◽  
Continuous Administration ◽  
Double Blind ◽  
Healthy Women ◽  
Dependent Relationship ◽  
Skin Conditions ◽  
Double Blinded

This clinical study was performed to evaluate the effects of continuous apple polyphenol (AP) administration on facial skin conditions and pigmentation induced by ultraviolet (UV) irradiation in healthy women participants. Participants (n = 65, age 20–39 years) were randomized to receive tablets containing AP (300 or 600 mg/day) or placebo in a double-blinded, placebo-controlled clinical trial. Continuous administration of AP for 12 weeks significantly prevented UV irradiation induced skin pigmentation (erythema value, melanin value, L value), although a dose-dependent relationship was not clearly observed. In contrast, no significant differences were detected between the groups with regard to water content and trans-epidermal water loss. Our study demonstrated that APs and their major active compounds, procyanidins, have several health benefits. Here, we report that continuous administration of AP for 12 weeks alleviated UV irradiation induced skin pigmentation, when compared with placebo, in healthy women.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

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