scholarly journals Does atorvastatin have augmentative effects with sodium valproate in prevention of migraine with aura attacks? A triple-blind controlled clinical trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Reza Ganji ◽  
Nastaran Majdinasab ◽  
Saeed Hesam ◽  
Nazanin Rostami ◽  
Mehdi Sayyah ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Sodium Valproate ◽  
Migraine With Aura ◽  
Vitamin D3 ◽  
Vascular Function ◽  
Intervention Group ◽  
Pain Severity ◽  
Controlled Clinical Trial ◽  
Prophylactic Regimen

Abstract Background Migraine is a painful and disabling nervous disorder which negatively affects the quality of life. Migraineurs may suffer from a generalized vasomotor dysfunction. Statins improve vasomotor and vascular function, with their pleiotropic effects. We aimed to assess efficacy and safety of adding Atorvastatin to prophylactic regimen in better control of migraine with aura. Methods This triple-blind controlled clinical trial was on 68 patients with migraine with aura. An interval of at least 1 month was given to evaluate vitamin D3 level and eligibility. In patients with vitamin D3 deficiency, the correction with vitamin D supplementation was provided. The patients were randomly assigned to receive atorvastatin 20 mg plus sodium valproate 500 mg or placebo plus sodium valproate 500 mg once a day for 2 months. The patients were evaluated based for the number of attacks and pain severity based on Visual Analogue Scale. Results There was a significant (p = 0.0001) improvement in severity of pain and number of migraine attacks by adding Atorvastin to the prophylactic regimen of patients with migraine with aura. After controlling for variable parameters, the differences between two arms of the study was yet statistically significant (p = 0.0001). A significant number of participants in intervention group were satisfied by their treatment (p = 0.001) with no remarkable side effects (P = 0.315). Conclusions Adding atorvastatin to migraine with aura preventive regimen may help reduce the number of acute attacks and pain severity without causing considerable side effects and led to a better patient satisfaction. Trial registration IRCT20180106038242N1. Registered: 7 February 2018.

scholarly journals Does Atorvastatin Help Prevent Classic Migraine Attacks? A Triple-Blind Controlled Clinical Trial

2020 ◽  
Author(s):  
Reza Ganji ◽  
Nastaran Majdinasab ◽  
Saeed Hesam ◽  
Nazanin Rostami ◽  
Mehdi Sayyah ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Sodium Valproate ◽  
Vitamin D3 ◽  
Vascular Function ◽  
Intervention Group ◽  
Vitamin D Supplementation ◽  
Pain Severity ◽  
Controlled Clinical Trial ◽  
Prophylactic Regimen

Abstract Background: Migraine is a painful and disabling nervous disorder which negatively affects the quality of life. Migraineurs may suffer from a generalized vasomotor dysfunction. Statins improve vasomotor and vascular function, with their pleiotropic effects. We aimed to assess efficacy and safety of adding Atorvastatin to prophylactic regimen in better control of classic migraine.Methods: This triple-blind controlled clinical trial was on 68 consecutive patients with history of classic migraine. An interval of at least one month was given to evaluate vitamin D3 level and eligibility. In patients with vitamin D3 deficiency, the correction was provided by administration of soft gelatin capsule of vitamin D supplementation. The patients were randomly assigned to receive atorvastatin 20mg plus sodium valproate 500mg or placebo plus sodium valproate 500mg once a day for two months. The patients were evaluated based for the number of attacks and pain severity based on Visual Analogue Scale. Results: There was a significant (p = 0.0001) improvement in severity of pain and number of migraine attacks by adding Atorvastin to the prophylactic regimen of patients. After controlling for variable parameters, the differences between two arms of the study was yet statistically significant (p = 0.0001). A significant number of participants in intervention group were satisfied by their treatment (p = 0.001). There was no remarkable difference in two arms of the study in terms of possible side effects (P =0.315).Conclusions: The results of present study suggested that adding atorvastatin to migraine preventive regimen may help reduce the number of acute attacks and pain severity. This modality did not cause considerable side effects and led to a better patient satisfaction.

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.

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

BMJ Open ◽  
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.

scholarly journals Effects of a Single Oral Megadose of Vitamin D3 on Inflammation and Oxidative Stress Markers in Overweight and Obese Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2021 ◽  
Vol Volume 14 ◽  
pp. 525-534
Author(s):  
Laine de Carvalho Guerra Pessoa Mamede ◽  
Rafaela Lira Formiga Cavalcanti de Lima ◽  
Alexandre Sérgio Silva ◽  
João Carlos Lima Rodrigues Pita ◽  
Nadjeanny Ingrid Galdino Gomes ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Clinical Trial ◽  
Vitamin D3 ◽  
Controlled Clinical Trial ◽  
Oxidative Stress Markers ◽  
Obese Women ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Stress Markers ◽  
And Oxidative Stress

scholarly journals The Effect of Rhythmic Breathing on the Severity of Sternotomy Pain after Coronary Artery Bypass Graft Surgery: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Hassan Babamohamadi ◽  
Masoumeh Karkeabadi ◽  
Abbasali Ebrahimian
Keyword(s):  
Clinical Trial ◽  
Pain Control ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Artery Bypass Graft ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Mean

Background. Moderate-to-severe pain is reported in up to 75% of the patients in the first 48 hours after cardiac surgery. Evidence suggests that distraction is an effective nursing intervention for controlling short-term and transient pain. Distraction can be achieved by various techniques, including progressive muscle relaxation, meditation, and rhythmic breathing (RB). The present research aimed at evaluating the impacts of RB on the severity of sternotomy pain after Coronary Artery Bypass Graft (CABG). Methods. This randomized, controlled clinical trial was conducted on 60 patients after CABG surgery at the open-heart surgery Intensive Care Unit (ICU) of Kowsar Hospital, affiliated to Semnan University of Medical Sciences in Semnan, Iran. The patients were selected through convenience sampling and randomly assigned to two groups, including (1) intervention or RB and (2) control groups. RB was performed in the intervention group every 12 hours (9 a.m. and 9 p.m.) for three consecutive days after the surgery. The control group received only routine care for pain control (opioid analgesics) with no additional interventions. The severity of pain was measured every day in both groups of patients before and after the interventions using the Visual Analog Scale (VAS). Results. The mean postintervention pain scores were significantly different from the mean preintervention scores in the intervention group ( p  < 0.05). The changes in the mean pain score in the intervention group were also significantly different from the corresponding changes in the controls ( p  < 0.05). Conclusion. Based on the results, the severity of pain after the intervention was significantly lower in the RB group compared to the control. RB was found to be an effective technique for reducing the patients’ pain and is therefore recommended as a post-CABG pain control technique. Iranian Registry of Clinical Trials: this trial is clinically registered with IRCT20120109008665N7, registered 3 September 2018.

Rosa Damascena Improved Sexual Dysfunction in Males Under Methadone Treatment – Results from a Double-Blind, Randomized, Placebo-Controlled Clinical Trial

2017 ◽  
Vol 41 (S1) ◽  
pp. S281-S281
Author(s):  
V. Farnia ◽  
F. Tatari ◽  
M. Alikhani ◽  
J. Shakeri ◽  
M. Taghizadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Sexual Dysfunction ◽  
Methadone Treatment ◽  
Controlled Clinical Trial ◽  
Rosa Damascena ◽  
Placebo Condition ◽  
Double Blind ◽  
Male Patients ◽  
Competing Interest

IntroductionPatients with severe opioid dependency might be treated with methadone, a pure μ-opioid-receptor, with promising results. Though, as for opioids, side effects are high, and among those, sexual dysfunction is among the most disturbing side effects.AimsInvestigating the influence of Rosa Damascena oil to improve sexual dysfunction among male methadone users.MethodsA total of 60 male patients (mean age: 30 years) with diagnosed opioid dependence and currently under treatment of methadone were randomly assigned either to the verum (Rosa Damascenca oil drops) or placebo condition. At baseline, and four and eight weeks later, patients completed self-rating questionnaires covering sexual dysfunction and happiness.ResultsOver time sexual dysfunction decreased and happiness increased in the verum, but not in the placebo condition.ConclusionsResults from this double blind, randomized, and placebo-controlled clinical trial showed that Rosa Damascena oil improved sexual dysfunction and happiness among male opioid addicts while under substitution treatment with methadone.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Abstract 16567: Long-Term Vascular Function in CTO Recanalization. A Randomized Clinical Trial of Ticagrelor vs. Clopidogrel

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Juan Jose Rodriguez Arias ◽  
Josep Gomez-Lara ◽  
Juan Caballero-Borrego ◽  
Luis Ortega-Paz ◽  
Luis Teruel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vascular Function ◽  
Drug Loading ◽  
Controlled Clinical Trial ◽  
Loading Dose ◽  
Clinical Value ◽  
Open Label ◽  
Total Occlusion

Background: Coronary vascular function of a chronic coronary total occlusion (CTO) immediately after recanalization is known to be poor and to be partially improved by pre-treatment with loading dose of ticagrelor vs. clopidogrel. It is unknown if this vascular dysfunction is maintained at long-term follow-up and may be improved by 1-year dual antiplatelet therapy (DAPT) with ticagrelor vs. clopidogrel. Methods: The TIGER is a prospective, open-label, two parallel-group controlled clinical trial, which 1:1 randomized 50 CTO patients to pre-PCI loading dose and subsequent 1-year DAPT with ticagrelor vs. clopidogrel. Coronary blood flow (CBF) under stepwise adenosine infusion was assessed after drug loading dose and at follow-up and compared between the two drug groups, adjusting for time of follow-up. Results: Out of 50 patients with index CBF evaluation, 38 (76%) patients underwent angiographic follow-up (23 and 15 at 1 and 3-year, respectively). A higher CBF area under the curve (AUC), already observed after loading dose in ticagrelor vs. clopidogrel group (p=0.027), was maintained at follow-up (AUC 34815.22±24206.06 vs. AUC 22712.47±13768.95; p=0.071). Specifically, whereas high ticagrelor loading dose-related CBF was sustained at follow-up (p=0.933), clopidogrel loading dose-related CBF increased at follow-up (p=0.039). Conclusion: The TIGER trial showed that DAPT with ticagrelor may maintain a higher CBF in a recanalized CTO as compared to clopidogrel, whose treated patients exhibit a lower CBF immediately after PCI with slight increase at follow-up. The clinical value of such sustained higher coronary flow should be evaluated in a larger group of patients.

scholarly journals Effect of hand reflexology on anxiety and physiological variables among patients hospitalized in the cardiac care unit: A randomized placebo controlled clinical trial

2017 ◽  
Vol 8 (4) ◽  
pp. 35 ◽  
Author(s):  
Zohre Rahmani ◽  
Nahid Rejeh ◽  
Majideh Heravi-Karimooi ◽  
Seyed Davood Tadrisi ◽  
Mojtaba Vaismoradi
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Intervention Group ◽  
Anxiety Level ◽  
Cardiac Care ◽  
Controlled Clinical Trial ◽  
Female Patients ◽  
Coronary Syndrome ◽  
Physiological Variables ◽  
Cardiac Care Unit

Background and objective: Admission to the cardiac care unit may cause physiological and psychological problems in patients. This study aimed to investigate the effect of hand reflexology on anxiety and physiological variables among female patients with acute coronary syndrome hospitalized in the cardiac care unit.Methods: This randomized placebo controlled clinical trial was conducted on 90 female patients hospitalized in the cardiac care unit in an urban area of Iran. The patients were chosen using a convenient sampling method and then were randomly assigned into intervention (n = 45) and placebo (n = 45) groups. While the intervention group received hand reflexology for 20 minutes, the placebo group received a simple touch of hand without the stimulation of reflexology points.  Demographic data was collected at the beginning of the study using face-to-face interviews with the patients. The anxiety level was assessed using the Spielberger’s State-Trait Anxiety Inventory (STAI) immediately after the intervention and 30 min after the intervention. Also, physiological variables including respiratory rate, heart rate, blood pressure and oxygen saturation were measured before, immediately after the intervention and 30 minutes after the intervention. Descriptive and inferential statistics were used for data analysis.Results: There was no statistically significant difference between the intervention and placebo groups before the intervention (p > .05). The anxiety level in the intervention group was significantly lower than that of the placebo group immediately after the intervention and 30 minutes after the intervention (p < .05, η = 0.090). However, no statistically significant differences in physiological variables between the groups were observed (p > .05).Conclusions: Hand reflexology influenced the level of anxiety. Therefore, nurses can use hand reflexology as a method for reducing patients’ anxiety along with other nursing interventions.

scholarly journals Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

2019 ◽  
Vol 53 ◽  
Author(s):  
Luciana Regina Ferreira da Mata ◽  
Cissa Azevedo ◽  
Mariana Ferreira Vaz Gontijo Bernardes ◽  
Tânia Couto Machado Chianca ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Home Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Teaching Program ◽  
Significant Difference ◽  
The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

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