scholarly journals Efficacy of two dosing schemes of a liquid containing ivy leaves dry extract EA 575 versus placebo in the treatment of acute bronchitis in adults

2019 ◽  
Vol 5 (4) ◽  
pp. 00019-2019 ◽  
Author(s):  
Axel Schaefer ◽  
Fanny Ludwig ◽  
Bruno M. Giannetti ◽  
Michael Bulitta ◽  
Anja Wacker
Keyword(s):  
Clinical Trial ◽  
Acute Bronchitis ◽  
Acute Cough ◽  
Observational Period ◽  
Double Blind ◽  
Dry Extract ◽  
Double Blind Clinical Trial ◽  
Efficacy Outcome ◽  
End Of Treatment ◽  
Verbal Category

IntroductionThe results of a clinical trial published in 2016 showed the efficacy of ivy leaves dry extract EA 575 versus placebo in the treatment of patients suffering from acute cough. A clinical trial with a very similar design was conducted to not only show the reproducibility of former results but also to investigate an alternative dosing scheme.MethodsThis randomised, placebo-controlled, multicentre, double-blind clinical trial was conducted to assess the efficacy and safety of a liquid containing EA 575 in the treatment of acute bronchitis. A total of 209 patients were treated with a liquid containing EA 575 as an active investigational medicinal product (verum) either two (7.5 mL) or three (5 mL) times a day or placebo in the respective dosing scheme for 1 week, with a total observational period of 2 weeks. The primary efficacy outcome was a change in Bronchitis Severity Score (BSS) of the pooled placebo and pooled verum groups between visits 1 and 5. Additional secondary parameters were assessed, including, for example, change in cough severity as assessed by a visual analogue scale (VAS) and the Verbal Category Descriptive (VCD) score.ResultsSuperiority of verum over placebo was during and at the end of treatment, as measured by BSS. No significant differences between the dosing schemes were observed. VCD scores and VAS measurements also showed the superiority of verum over placebo.ConclusionThe existing data on the clinical efficacy of EA 575 were confirmed. Furthermore, a new dosing scheme was shown to be noninferior to the currently used scheme while maintaining the safety and tolerability of the well-established cough liquid containing EA 575.

scholarly journals The efficacy, safety, and tolerability of levofloxacin quadruple therapy for helicobacter pylori eradication: a randomized, double-blind clinical trial

2020 ◽  
Author(s):  
Fariborz Mansour-Ghanaei ◽  
Behnam Masihypour ◽  
Mohammad Fathalipour ◽  
Soheil Hassanipour ◽  
Homayoon Sokhanvar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Alternative Therapy ◽  
Double Blind ◽  
Intention To Treat ◽  
Bismuth Subcitrate ◽  
Double Blind Clinical Trial ◽  
End Of Treatment ◽  
H Pylori ◽  
To Receive

Abstract BackgroundThe incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori.MethodsIn a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention.ResultsAccording to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1% (95% CI: 39.3–57.8) and 47.6% (95% CI: 39.7–58.4), respectively compared to the BPAL- 10 regimen 62.7% (95% CI: 53.6–72.8) and 62.4% (95% CI: 55.1–72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6%) and BPAL-10 (36.7%) groups.ConclusionAlthough the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19). This trial was retrospectively registered on July 10, 2015.

scholarly journals The Efficacy, Safety, And Tolerability of Levofloxacin Quadruple Therapy For Helicobacter Pylori Eradication: A Randomized, Double-Blind Clinical Trial

2021 ◽  
Author(s):  
Fariborz Mansour-Ghanaei ◽  
Behnam Masihypour ◽  
Mohammad Fathalipour ◽  
Soheil Hassanipour ◽  
Homayoon Sokhanvar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Alternative Therapy ◽  
Double Blind ◽  
Intention To Treat ◽  
Bismuth Subcitrate ◽  
Double Blind Clinical Trial ◽  
End Of Treatment ◽  
H Pylori ◽  
To Receive

Abstract The incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori. In a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention. According to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1 % (95 % CI: 39.3-57.8) and 47.6 % (95 % CI: 39.7-58.4), respectively compared to the BPAL- 10 regimen 62.7 % (95 % CI: 53.6-72.8) and 62.4 % (95 % CI: 55.1-72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6 %) and BPAL-10 (36.7 %) groups. Although the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19).

Analgesic Effect of Nebulized Versus Intravenous Fentanyl for Pain Relief of Limb Fracture: A Double-Blind Clinical Trial

2017 ◽  
Vol 11 (1) ◽  
pp. 101-106
Author(s):  
Mohammadreza Maleki Verki ◽  
Kambiz Masoumi ◽  
Hassan Motamed ◽  
Meisam Moezi ◽  
Arash Forouzan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Relief ◽  
Normal Saline ◽  
Pain Level ◽  
Fentanyl Citrate ◽  
Double Blind ◽  
Intravenous Fentanyl ◽  
Limb Fracture ◽  
Double Blind Clinical Trial ◽  
Fentanyl Group

Background:More than half of the patients attending emergency centers need analgesics. Injectable analgesics are currently the most common pain control strategy, but entail complications. Fentanyl is one of the most commonly used pain-relief opiates available in various forms.Objective:The present study aims to compare analgesic effects of nebulized against intravenous fentanyl for controlling pain due to limb fracture.Method:The present double-blind clinical trial recruited 213 patients presenting with fractured limbs to emergency departments. The first group of patients received 1 micg/kg of intravenous fentanyl citrate from a solution of 50 micg/ml and 5 ml of normal saline in nebulized form (group A), and the second group intravenously received 5 ml of normal saline and 4 micg/kg of 50 micg/ml solution of fentanyl citrate in nebulized form, whose volume reached 5 ml with the addition of normal saline (group B). Then, pain level was frequently measured and compared in the two groups for 20 minutes.Results:The results obtained showed reduced pain level in both the groups. However, point-by-point comparison of pain in the two groups revealed significantly greater pain reduction in intravenous fentanyl group (P<0.001). The need for adjuvant pain relief medication was 8.3% in intravenous fentanyl group and 24% in nebulized fentanyl group, with a significant difference between the two groups (P=0.002).Conclusion:According to the results, although nebulized fentanyl is effective in controlling pain due to limb fracture, it was less effective than intravenous type, and unable to control pain in many cases.

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