Effects of Dose Titration on Dipyridamole-Induced Headache: A Randomized, Double-Blind Clinical Trial

2022 ◽  
pp. 1-6
Author(s):  
Min Kyoung Kang ◽  
Jae-Kwan Cha ◽  
Dae-il Chang ◽  
Hyun Young Kim ◽  
Jong-Won Chung ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Primary Endpoint ◽  
Dose Titration ◽  
Control Group ◽  
Standard Group ◽  
Double Blind ◽  
Once Daily ◽  
Double Blind Clinical Trial ◽  
Ischemic Attack

<b><i>Purpose:</i></b> The aim of this study is to investigate the effect of gradual dipyridamole titration and the incidence of dipyridamole-induced headache in patients with ischemic stroke or transient ischemic attack (TIA). <b><i>Methods:</i></b> A randomized, double-blind, double-placebo, parallel group, phase 4 clinical trial (KCT0005457) was conducted between July 1, 2019, and February 25, 2020, at 15 medical centers in South Korea. The study included patients aged &#x3e;19 years diagnosed with a noncardioembolic ischemic stroke or TIA within the previous 3 weeks. The participants were randomized 1:1:1 to receive Adinox® (aspirin 25 mg/dipyridamole 200 mg) and aspirin (100 mg) once daily for the first 2 weeks followed by Adinox® twice daily for 2 weeks (titration group), Adinox® twice daily for 4 weeks (standard group), and aspirin 100 mg once daily for 4 weeks (control group). The primary endpoint was incidence of headache over 4 weeks. The key secondary endpoint was mean cumulative headache. <b><i>Results:</i></b> Ninety-six patients were randomized into the titration (<i>n</i> = 31), standard (<i>n</i> = 32), and control (<i>n</i> = 33) groups. The titration and standard groups (74.1% vs. 74.2%, respectively) showed no difference in the primary endpoint. However, the mean cumulated headache was significantly lower in the titration group than in the standard group (0.31 ± 0.46 vs. 0.58 ± 0.51, <i>p</i> = 0.023). Further, adverse drug reactions were more common in the standard group than in the titration group (28.1% vs. 9.7%, respectively, <i>p</i> = 0.054), although not significantly different. <b><i>Conclusion:</i></b> The titration strategy was effective in lowering the incidence of cumulative dipyridamole-induced headache.

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

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.

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

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.

scholarly journals Effects of an iron supplementation trial on the Fe status of Thai schoolchildren

1992 ◽  
Vol 68 (1) ◽  
pp. 245-252 ◽  
Author(s):  
Phongjan Hathirat ◽  
Aree Valyasevi ◽  
Nittaya J. Kotchabhakdi ◽  
Nipa Rojroongwasinkul ◽  
Ernesto Pollitt
Keyword(s):  
Clinical Trial ◽  
Serum Ferritin ◽  
Iron Supplementation ◽  
Transferrin Saturation ◽  
Control Group ◽  
Iron Supplement ◽  
Double Blind ◽  
Free Erythrocyte Protoporphyrin ◽  
Double Blind Clinical Trial ◽  
Hb H Disease

A double-blind clinical trial was conducted among 9- to 11-year-old children in sixteen schools in the Chon Buri province of Thailand to assess the effects of an iron supplement combined with an anthelminthic agent (i.e. albendazole). In addition to the albendazole, Fe or placebo tablets were distributed to 2268 children enrolled in grades three to five without knowledge of the Fe status of the children. Criteria for case inclusion were: (a) absence of A E Bart's or haemoglobin (Hb) H disease, (b) absence of abnormal Hb EE, and (c) age, 108–144 months. The results showed a significant improvement in the Fe status of the children after 16 weeks of treatment. The increments were: Hb from 124 to 128 g/l, serum ferritin from 34.54 to 104.72 μg/l, transferrin saturation from 24.09 to 35.05%; free erythrocyte protoporphyrin decreased from 444.7 to 281.4 μg/l erythrocytes. These changes were significantly greater than in the control group that received only the anthelminthic agent. However, the administration of albendazole only also resulted in significant changes in the same Fe indicators.

scholarly journals Clinical effect of a herbal dentifrice on the control of plaque and gingivitis: a double-blind study

2003 ◽  
Vol 17 (4) ◽  
pp. 314-318 ◽  
Author(s):  
Claudio Mendes Pannuti ◽  
Joyce Pereira de Mattos ◽  
Paula Nini Ranoya ◽  
Alberto Martins de Jesus ◽  
Roberto Fraga Moreira Lotufo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Effect ◽  
Test Group ◽  
Control Group ◽  
Double Blind Study ◽  
Gingival Index ◽  
Control Groups ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference

The aim of this randomized, double-blind clinical trial was to evaluate the effect of the Paradontax dentifrice on the reduction of plaque and gingivitis. Subjects were randomly allocated into either the test group (n = 15, Paradontax) or the control group (n = 15, standard dentifrice with fluoride). Plaque levels were measured using the Turesky modification of the Quigley & Hein Plaque Index (PI), and gingivitis was evaluated with the Gingival Index (GI). Subjects were asked to brush their teeth with the allocated dentifrice, three times a day, for 21 days. There was no significant difference between groups in relation to the PI and GI medians, at baseline and at the end of the 21-day period. There was no significant reduction in PI in either the test or control groups. There was a significant decrease in GI in the test group. The authors concluded that there was no difference between the dentifrices in the reduction of plaque and gingivitis.

Effect of Fenticonazole in Vaginal Candidiasis: A Double-Blind Clinical Trial versus Clotrimazole

1986 ◽  
Vol 14 (6) ◽  
pp. 306-310 ◽  
Author(s):  
Earl Brewster ◽  
Piero Monici Preti ◽  
Ralf Ruffmann ◽  
John Studd
Keyword(s):  
Clinical Trial ◽  
Previous History ◽  
Vaginal Candidiasis ◽  
Control Group ◽  
Apparent Difference ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Antimycotic Activity ◽  
Objective Evidence ◽  
History Of

Fenticonazole is an imidazole derivative which possesses a broad spectrum antimycotic activity, including activity against Candida albicans. Its therapeutic activity and tolerability have been evaluated, in a double-blind clinical trial versus clotrimazole, in 54 patients affected by mycologically confirmed symptomatic vaginal candidiasis. Both drugs were administered intravaginally as a cream once a day for 7 days. Assessment was by laboratory mycological investigations and symptomatic evaluation. Patients ‘cured’ at the end of the trial were re-evaluated after 4–6 weeks for possible relapses. Both treatments resulted in a progressive, statistically significant reduction in vaginal symptoms (itching and discharge) and in elimination of Candida in more than 95% of patients. When ‘cured’ patients were reassessed 4–6 weeks after therapy, relapses occurred in four patients after fenticonazole treatment, but in none following clotrimazole treatment. This apparent difference between treatments is far from being statistically significant and, therefore, may have been a chance occurrence. It should also be noted that patients from the fenticonazole group had a previous history of significantly more frequent episodes of candidiasis suggesting that they may have been at greater risk of re-infection than patients from the control group. The tolerance of both treatments was excellent since no local or systemic signs or symptoms of toxicity were reported. An equally high efficacy and safety for both drugs in the elimination of symptoms and objective evidence of vaginal candidiasis is indicated.

scholarly journals The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial

2020 ◽  
Vol 20 (1) ◽  
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 ◽  
Link Type ◽  
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 3 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 = 0.025). 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.

scholarly journals Effect of allopurinol on diabetic nephropathy; a double-blind clinical trial study

2020 ◽  
Vol 10 (1) ◽  
pp. e03-e03
Author(s):  
Saeed Mardani ◽  
Farzaneh Kadkhodaei-Elyaderani ◽  
Ali Momeni ◽  
Maryam Saeedi
Keyword(s):  
Clinical Trial ◽  
Diabetic Nephropathy ◽  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Urinary Protein ◽  
Control Group ◽  
Double Blind ◽  
Diabetic Kidney ◽  
Lymphocyte Ratio ◽  
Double Blind Clinical Trial

Introduction: Diabetic nephropathy (diabetic kidney disease) is the most common cause of renal failure. Objectives: Regarding the role of allopurinol in the improvement of diabetic kidney disease, this study aimed to investigate the ameliorative effect of allopurinol in diabetic nephropathy patients. Patients and Methods: This double-blind clinical trial study was performed on 60 patients with diabetic kidney disease referenced to nephrology clinic during 2019-2020. Patients were divided into case (treated with allopurinol 100 mg/d) and control (received placebo pill) groups. Three and six months of intervention, complete blood count (CBC), fasting blood sugar levels (FBS), serum blood urea nitrogen (BUN) levels, creatinine (Cr) and uric acid (UA) levels, 24 hours urinary protein, glomerular filtration rate (GFR), neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) were measured and compared between the two groups. Results: After six months, reduction of UA and 24 hours urinary protein were not significant in the control group (P > 0.05) but it was significant in the allopurinol group (P < 0.05). In the allopurinol group, NLR and PLR levels decreased significantly during the six months (P < 0.01) however there was no significant change in the control group (P > 0.05). Conclusion: Low dosage of allopurinol (100 mg/d) reduces UA, proteinuria, NLR and PLR in patients after six months. Therefore it can be used for diabetic nephropathy patients as a supplementary, inexpensive and safe treatment.

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