placebo control trial
Recently Published Documents


TOTAL DOCUMENTS

67
(FIVE YEARS 17)

H-INDEX

13
(FIVE YEARS 1)

2021 ◽  
Vol 8 (12) ◽  
pp. 530-534
Author(s):  
Ketki Jandial ◽  
Shagufta Tabassum

Background: Postoperative sore throat (POST) is considered to be quite common complaint. Its symptoms tend to improve with time, but use of oral zinc lozenge has been shown to reduce the incidence and severity of POST. The aim of the present study was to find the efficacy of oral zinc sulfate, given 30 min preoperatively, in reducing POST, primarily caused by endotracheal intubation, till 24 hours after surgery. Method: A prospective, randomized, double-blinded, placebo-control-trial study was conducted on 80 patients, further divided into two groups of 40 patients each, between the age group of 18-60 years, of either gender, in Super Specialty Hospital, GMC Jammu, over a period of 6-months. The two groups received either dispersible zinc tablet or a placebo. The severity of POST was graded on a 4-point scale ranging from 0 to 3 and evaluation was repeated at 30 min, 2, 4, and 24 hour, postoperatively. Results: The difference in severity of sore throat was found to be statistically significant at all evaluation time intervals, except at 24 hours, which was quite lower in Zinc group. The overall incidence of POST in Zinc group was 26.3%, which was significantly higher at 50% in placebo group. Conclusion: A dose 40 mg zinc dispersible tablet, equivalent to 40 mg elemental zinc, given 30 min before surgery, effectively reduced the incidence and severity of POST. Keywords: Post Operative Sore Throat, Oral Zinc Lozenge, Endotracheal Intubation.


Author(s):  
Marcela González-Gross ◽  
Carlos Quesada-González ◽  
Javier Rueda ◽  
Manuel Sillero-Quintana ◽  
Nicolas Issaly ◽  
...  

Recreational running (RR) is becoming a popular way to increase physical activity for improving health, together with a higher incidence of knee injuries. The aim was to analyze the effect of a four-week supplementation with a mixture of Harpagophytum procumbens, Zingiber officinale and Bixa orellana on males, middle-aged, RR with an undiagnosed knee discomfort. A randomized triple-blind placebo-control trial was conducted among male RR aged 40–60 years suffering from self-declared knee discomfort after training. Participants were assigned to supplementation (2 g/day in 6 doses; n  =  13; intervention group (IG)) or matched placebo (n  =  15; control group (CG)) for 4 weeks. At pre- and post-intervention, assessment of routine blood biomarkers, body composition, running biomechanics and body temperature was performed using standardized procedures. Machine learning (ML) techniques were used to classify whether subjects belonged to IG or CG. ML model was able to correctly classify individuals as IG or CG with a median accuracy of 0.857. Leg fat mass decreased significantly (p = 0.037) and a deeper reduction in knee thermograms was observed in IG (p < 0.05). Safety evaluation revealed no significant differences in the rest of parameters studied. Subjects belonging to IG or CG are clearly differentiated, pointing into an effect of the supplement of ameliorating inflammation.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12100-12100
Author(s):  
Chalermchai Lertanansit ◽  
Wasamol Mahaparn ◽  
Virote Sriuranpong ◽  
Piyada Sitthideatphaiboon ◽  
Nattaya Sintawichai ◽  
...  

12100 Background: Prevention of chemotherapy-induced nausea and vomiting (CINV) is vital in cancer treatment. Here, we compared the efficacy of netupitant-containing regimen; composed of NEPA, dexamethasone, and olanzapine (NEPAs), which is recommended for preventing CINV from high-emetogenic chemotherapy (HEC) to standard 3-drugs; ondansetron, dexamethasone, olanzapine for preventing CINV from high-dose cisplatin (≥75 mg/m2). Methods: This randomized, double-blind, placebo-control trial randomly assigned untreated patients who were received high-dose cisplatin in a 1:1 ratio to either NEPAs or standard 3-drugs combination regimen. Dose of dexamethasone in NEPAs regimen was modified after preplanned interim safety analysis to increase from 4 to 8 mg per day on days 2-4. The stratification factors were concurrent treatment with radiation and sex. The primary endpoint was the overall complete response (CR) rate defined as no vomiting and no use of rescue antiemetic drugs. The protocol allowed crossover to NEPAs for those who received standard 3-drugs and did not reach CR in the first cycle. We collected outcome in the first 2-cycle of treatment. Results: Between January 2019 and December 2020, hundred patients were randomly assigned to either NEPAs (n = 51) or in-house standard 3-drugs (n = 49). Demographic characteristics were well-balanced in both arms. Total events in both arms were 101 events for NEPAs and 78 events for standard 3-drug. Overall CR rate were 70% and 69% in NEPAs and standard 3-drugs, ( p-value 0.87) respectively. According to emesis phase, CR in acute (0- 24 hrs.) and delay phase (24-120 hrs.) were not different in both arms; 91% vs. 89% and 72% vs. 71% in NEPAs and standard 3-drugs respectively. However, mean nausea VAS score was significantly lower in NEPAs (1.63 vs. 2.02, p-value = 0.001). The ad hoc subgroup analysis shown similar efficacy between before and after protocol amendment of NEPAs regimen in term of delay emesis CR rate; 70.9% vs. 73.9% ( p-value 0.73). Conclusions: The NEPA-containing regimen did not show superiority compare to standard 3-drug in terms of complete response rate for CINV prevention among patients receiving high-dose cisplatin. Furthermore, the dexamethasone dosage of 4 vs. 8 mg per day might not affect the efficacy of delay emesis of the NEPAs regimen. Clinical trial information: TCTR20190508001. [Table: see text]


2021 ◽  
Author(s):  
Ramin Tolouian ◽  
Omid Moradi ◽  
Zuber D. Mulla ◽  
Shadi Ziaie ◽  
Mehrdad Haghighi ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document