scholarly journals An open-label, multicentre, randomized comparative study of efficacy, safety and tolerability of the 5 plant - extract BNO 1012 in the Delayed Antibiotic Prescription Method in children, aged 6 to 11 years with acute viral and post-viral rhinosinusitis

2020 ◽  
Vol 41 (5) ◽  
pp. 102564 ◽  
Author(s):  
Vasyl I. Popovych ◽  
Halyna V. Beketova ◽  
Ivana V. Koshel ◽  
Olha A. Tsodikova ◽  
Tetiana A. Kriuchko ◽  
...  
2021 ◽  
Author(s):  
V. I. Popovych ◽  
I. V. Koshel ◽  
O. N. Malofiichuk ◽  
L. I. Pyletska ◽  
O. A. Semeniuk ◽  
...  

AbstractAcute bacterial tonsillitis occurs in 20 –30 % of immunocompetent children; however, the frequency of antibacterial drug prescriptions reaches up to 90 %. Delayed antibiotic prescription is recommended by current guidelines. The study objective was to determine the efficacy of phytoneering extract BNO 1030 in the technology of delayed antibiotic prescription in patients with severe acute tonsillitis.MethodsIn the multicenter, randomized, open-label, comparative study, 182 out of 200 randomized children with acute tonsillitis aged 6 –12 years completed the study. Evaluation criteria: a reduced severity of sore throat when swallowing and at rest, throat irritation at rest, hyperemia of the tonsils assessed by a physician according to a 4-point scale at each visit compared to Visit 1, dynamics of self-assessment of general well-being, intensity of sore throat and difficulty swallowing according to a 10-point visual analogue scale, frequency of antibiotic prescriptions, therapeutic benefit from BNO 1030 in days.ResultsThe use of phytotherapeutic medicinal product BNO 1030 in addition to the standard symptomatic treatment of severe acute tonsillitis provides a clinically significant, adequate reduction in the symptom severity assessed by a physician at V2 (p < 0.005). There are significant differences in the patient’s self-assessment of the symptoms from treatment Day 2 (p < 0.005). This allows to significantly reduce the duration of systemic antipyretic administration (p < 0.005). In the first days of treatment, when a decision on delay of antibiotic prescription is made, a therapeutic benefit in two days in patients of the treatment group was observed compared to the control group. The use of BNO 1030 in patients with severe acute tonsillitis significantly reduces, by 43.7 % or 2.3 times, the need for prescribing antibiotic therapy as part of the technology of delayed antibiotic prescription (p < 0.005). During treatment, no side effects and complications of the disease were recorded.ConclusionBNO 1030 is a safe and effective medicinal product for the treatment of severe acute tonsillitis in children aged 6 –12 years. It provides a significant therapeutic benefit when administered in addition to standard symptomatic therapy and reduces the irrational antibiotic prescription.Trial registrationClinicalTrials.gov Identifier: NCT04537819https://clinicaltrials.gov/ct2/show/NCT04537819?term=ATi-2&draw=2&rank=1


2020 ◽  
Vol 12 (1) ◽  
pp. 59-68
Author(s):  
Alex Souto Maior ◽  
Marcio Tannure ◽  
Fábio Eiras ◽  
Arthur de Sá Ferreira

SummaryStudy aim: This study compared the effects of intermittent negative pressure therapy (INPT) vs. active recovery therapy (ART) on post-match physiological parameters such as serum CK level and skin temperature of the lower limbs in elite soccer players.Material and methods: Twenty healthy male professional soccer players from a Brazilian first division soccer club were enrolled in this randomized, parallel arm, open label, comparative study. After participating in 2 soccer matches, they were randomly assigned to two groups (n = 10) to receive a 30-min session of INPT (intermittent exchange of hypobaric pressure range 33 to 51 mmHg) or ART (self-myofascial release, mobility and stability exercises, and cycle ergometer exercise). The intervention was conducted after a match with assessments immediately before and after the intervention and again 24 h after the intervention.Results: A significant interaction effect (F2,36 = 4.503, p = 0.018, η2 = 0.130) was observed, indicating that the decrease of CK from pre-intervention to 24 h post-intervention was greater in the INPT than in the ART group. Lower limb skin temperature was significantly lower after INPT than after ART (p < 0.003).Conclusions: Serum CK level and skin temperature of lower limbs showed better recovery up to 24 h after the intervention with INPT in elite soccer players.


Author(s):  
VASUNDHARA BHOPLE ◽  
DEEPAK BHOSLE

Objective: The objective of this study was to compare the effect of chitosan, lifestyle modification, and combination of chitosan and lifestyle modification on body mass index (BMI) in obese patients. Methods: A prospective, randomized, open-label comparative study conducted for the period of 24 weeks. The study population was enrolled in three groups (chitosan 500 mg BD, lifestyle modification, and chitosan 500 mg BD and lifestyle modification). Data were analyzed using “t”-test and ANOVA. Results: There is a reduction in BMI in all the three groups. However, when we combined chitosan and lifestyle modification, there is pronounced reduction in BMI, which is statistically significant (p<0.0001). Conclusions: Chitosan and lifestyle modification have more pronounced effect on reduction on BMI as compared to monotherapy alone.


Author(s):  
Saravanan Periyannan ◽  
Chenthamarai G

Objective: To evaluate the efficacy and tolerability of lysine cream in patients with second-degree superficial burns.Methods: In this randomized, open label, comparative study patients with second degree superficial burns received either combination of lysine cream 15% and silver sulfadiazine cream 1% or sulfadiazine cream 1% alone, twice daily for period of 4 weeks. The primary outcome, pain, discharge, size and total body surface area (TBSA) were assessed in each visits.Results: Patients in the study group showed significant change than the control group in pain, discharge, size, and TBSA during the first 4 weeks after treatment. In addition, significantly more patients in lysine group had adequate relief of itching and increased epithelialization.Conclusions: Combination of lysine cream and silver sulfadiazine cream for 4 weeks provided significant relief of pain, discharge, size, TBSA, and itching. Lysine cream was well tolerated.Keywords: Growth factor, Angiogenesis, Lysine, Body surface area.


Sign in / Sign up

Export Citation Format

Share Document