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Trial size herbal supplements -

Findings In this randomized clinical trial that included patients with sepsis, the day mortality rate was Meaning Among patients with sepsis, treatment with XBJ, compared with the placebo group, resulted in lower day mortality.

Importance Previous research has suggested that Xuebijing injection XBJ , an herbal-based intravenous preparation, may reduce mortality among patients with sepsis. Objective To determine the effect of XBJ vs placebo on day mortality among patients with sepsis.

Design, Setting, and Participants The Efficacy of Xuebijing Injection in Patients With Sepsis EXIT-SEP trial was a multicenter, randomized double-blind, placebo-controlled trial conducted in intensive care units at 45 sites and included randomized patients with sepsis sepsis 3.

Patients aged 18 to 75 years with a Sequential Organ Failure Assessment score of 2 to 13 were enrolled. The study was conducted from October to June The final date of follow-up was July 26, Data analysis was performed from January to August Main Outcomes and Measures The primary outcome was day mortality.

Results Among the patients who were randomized mean [SD] age, In these patients, the day mortality rate was significantly different between the placebo group and the XBJ group of patients [ The absolute risk difference was 7.

The incidence of adverse events was of patients Conclusions and Relevance In this randomized clinical trial among patients with sepsis, the administration of XBJ reduced day mortality compared with placebo. Trial Registration ClinicalTrials. gov Identifier: NCT Sepsis, a systemic disease that deteriorates rapidly with multiple organ dysfunction, is caused by dysregulated inflammatory response to infection and remains one of the leading causes of mortality worldwide.

Xuebijing injection XBJ , an herbal-based intravenous preparation, was licensed in by the National Medical Products Administration NMPA, China for the treatment of sepsis and multiple organ dysfunction syndrome. Previous studies have suggested that XBJ could also increase the activity of superoxide dismutase, regulate hypersensitive or hyposensitive immune responses, and prevent the development of organ dysfunction in acute insults.

A well-conducted randomized study of patients with severe pneumonia showed that treatment with XBJ had impressive benefit. To our knowledge, this is the largest study yet to show there is benefit to using this herbal-based preparation.

Two independent systematic reviews with meta-analyses patients and patients, respectively also suggested, with a moderate certainty level of evidence, that XBJ was significantly associated with favorable outcomes and survival in patients with sepsis.

Accordingly, this double-blind, placebo-controlled, multicenter study was conducted to determine the efficacy and the adverse effects of XBJ in addition to the standard care for patients with sepsis.

The Efficacy of Xuebijing Injection in Patients With Sepsis EXIT-SEP trial was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial. The trial protocol Supplement 1 has been previously published 18 and is also available at ClinicalTrials.

gov NCT The trial followed the principles of the Declaration of Helsinki and was conducted in accordance with the Good Clinical Practices and Chinese regulations. This trial was approved by the Ethics Committee of Zhongda Hospital, Southeast University ZDSYLLP01 , and the institutional review board or independent ethics committee at each participating site.

Written informed consent was obtained from all patients or legally authorized representatives. Any study-specific procedures were performed in accordance with all applicable ethical, regulatory, and local requirements.

The trial was overseen by a blinded steering committee and an independent data and safety monitoring board. The steering committee oversaw the conduct and decision-making during the trial and made recommendations to the principal investigator.

The data and safety monitoring board oversaw the safety of the trial. This study followed the Consolidated Standards of Reporting Trials CONSORT reporting guideline. The trial was conducted in the intensive care units ICUs at 45 sites across China between October and June , and final follow-up occurred in July All consecutive adult patients admitted in the ICUs and diagnosed with sepsis 3.

Patients aged 18 to 75 years were eligible for enrollment if they had a Sequential Organ Failure Assessment SOFA score of 2 to Concealment of the randomized assignment was ensured by means of a centralized, secure, web-based system. These professionals had no interactions with the investigators, and the investigators were not aware of the block sizes and stratification.

The patients who met all the inclusion criteria and had none of the exclusion criteria were assigned randomly, in a ratio, to receive mL of XBJ manufactured by Tianjin Chase Sun Pharmaceutical Co, Ltd, Z mixed with mL of normal saline every 12 hours or matching placebo mL for 5 consecutive days.

The chemical composition of XBJ is listed in the eAppendix in Supplement 2. These interventions were administered by a dedicated study nurse or a trained ICU nurse. The placebo and XBJ were supplied in identical labels.

Opaque tubing and the covering of infusion bag with plastic sleeves were used to obscure any identifying features of the infusion. During the study, only the drug managers and study nurses who prepared the study drugs were aware of the allocation information of the patients, but these drugs managers and nurses did not participate in the data collection and outcome evaluation.

The investigators followed the local sepsis management guidelines and the international guideline for management of sepsis and septic shock Details of sepsis management were recorded in the case report form. The primary outcome was all-cause mortality 28 days after the randomization.

The key secondary outcomes included were ICU and hospital mortality, ICU and hospital length of stay, day ICU-free days with a maximum of 28 days [best] and a minimum of 0 days [worst] , day cumulative mechanical ventilation—free days, and change in Acute Physiology and Chronic Health Evaluation APACHE II score and the SOFA score change at day 3 and day 6.

The SOFA scores in the trial ranged from 0 normal organ function to 24 worst organ dysfunction. The change in the SOFA score was defined as a fixed-day SOFA score minus initial-day SOFA score.

SOFA scores were calculated on days 3 and 6 in the EXIT-SEP trial. Detailed definitions of the outcomes are provided in the study protocol in Supplement 1.

The safety outcomes included any adverse events AEs and severe adverse events SAEs through 28 days of follow-up. The clinically significant laboratory abnormalities were required to be captured as AEs. These reports were analyzed by the study coordinating center together with the investigators.

The patients, their surrogates, or their primary care physicians were contacted if additional data were needed. The trial data were monitored by independent monitors, and the data were monitored centrally by the staff from the coordinating center according to a prespecified monitoring plan in the study protocol in Supplement 1.

Based on the previous Chinese Epidemiological Study of Sepsis CHESS study 20 conducted in China, a day all-cause mortality rate of The primary outcome was assessed by fitting a generalized linear model with a binomial distribution and identity link. The patients with an unknown mortality status at day 28 were not imputed for testing of the primary outcome.

The same model was applied for other categorical variables, such as mortality ICU, hospital. The Kaplan-Meier method and log-rank test were used to compare survival curves from randomization until 28 days. The results of these subgroup analyses are presented in a forest plot in eFigure 2 in Supplement 2.

Changes in the SOFA score and APACHE II score from baseline were analyzed by fitting linear mixed-effects models using the baseline value, treatment, visit, and treatment-by-visit interaction as fixed effects. The same approach without baseline adjustment was used for the other continuous variables, such as ICU-free days, mechanical ventilation—free days, and length of stay ICU, hospital.

The AE data were provided for descriptive purposes only. To assess the robustness of the primary analyses, sensitivity analyses were performed. First, missing data for the primary outcome were imputed using the multiple imputation method under the missing-at-random assumption.

Second, a prespecified analysis used a control-based pattern model to evaluate sensitivity to missing data departure from the assumption. A worse-case analysis and a tipping point analysis for the primary outcome were also performed. All the efficacy analyses were performed in the intention-to-treat ITT population, which is defined as all randomized participants.

Safety analyses were conducted for the patients in the ITT group who received at least 1 treatment session. Statistical analyses were performed using SAS, version 9. No adjustment was made for multiple comparisons; therefore, the secondary outcomes should be interpreted as exploratory.

Between October 20, , and June 29, , participants from 45 ICUs across 22 provinces in China were screened for eligibility, and The follow-up continued through July 26, Of the remaining participants, The reasons for discontinuation of the treatment are provided in Figure 1.

The baseline demographics, severity of illness, and comorbidities were well balanced between the study groups Table 1. In both groups, the mean baseline SOFA score was approximately 7. The mean APACHE II score range, ; a higher score indicates greater severity of illness and higher risk of death was approximately 12 in both groups.

The mean time from sepsis identification to randomization was 1. The primary sites of infection at baseline were comparable in the 2 groups Table 1. The 2 most common sites of infection were the lung of , New infection after admission occurred in As a concomitant medication, glucocorticoids were administered to approximately a quarter of the patients in both groups eTable 1 in Supplement 2.

The day mortality rate was of patients The Kaplan-Meier survival curve for the full analysis set is shown in Figure 2. Fifty-seven patients 33 in the XBJ group and 24 in the placebo group had an unknown mortality status at day 28 and were assessed as assumed alive by the investigators.

Similar results were confirmed in the 2 sensitivity analyses eTable 2 in Supplement 2 , worse-case analysis eTable 3 in Supplement 2 , and tipping point analysis eFigure 1 in Supplement 2. There was a significant between-group difference in the ICU mortality after randomization placebo, The results of the secondary outcomes were considered exploratory only.

We performed efficacy analyses across subgroups by age, baseline SOFA score, baseline APACHE II scores, mechanical ventilation, septic shock, ICU types, and continuous renal replacement therapy. In subgroup analyses, the difference in the day mortality rates between the placebo and XBJ groups was 7.

The findings were broadly consistent between the ITT population and subgroup analyses. Overall, patients The non—end point AEs are enumerated in eTable 4 in Supplement 2.

The most common AE in the XBJ group was elevated alanine aminotransferase level 51 of , 5. Other AEs in the XBJ group included elevated aspartate aminotransferase level 38 of , 4.

There were similar distributions of AEs in the XBJ and placebo groups with no reports of drug-related SAEs. There were no treatment discontinuations due to drug toxicity.

This large-scale randomized clinical trial found that patients with sepsis treated with XBJ had significantly lower mortality at 28 days compared with placebo. The main findings from the subgroup analyses were consistent with the primary analysis.

In addition, XBJ could also reduce ICU mortality and was associated with cumulative mechanical ventilation—free days and ICU-free days in patients with sepsis during the day follow-up period, as compared with placebo.

While this study was powered to detect differences in the secondary outcomes, the statistically significant difference in these secondary outcomes should be cautiously interpreted considering that there were 10 secondary outcomes without adjustment for multiple comparisons. There were no statistically significant differences in the occurrence of AEs between the 2 groups.

Progress in the development of novel therapeutics to treat sepsis has come to a virtual standstill. The trial was prospectively powered to detect a 6-percentage-point difference in day survival based on the results of the CHESS analysis. Notably, a clear mortality difference between other countries and China was again shown in the EXIT-SEP trial.

The mortality finding of the placebo group is strongly consistent with that of the nationwide CHESS study. There are several possible reasons for this finding. Sepsis trials are particularly challenging due to the heterogeneity of the patient population. Based on the previous analyses, the entry criteria written into the current clinical trial protocol was a SOFA score of 2 to The mortality rate was Considering the above reasons, the present study further quantified the consistency of SOFA change to reflect the treatment effects on mortality.

Additionally, the experience of vasopressin and septic shock trials suggested that the sepsis 3. The mortality rate in the placebo group Recent studies have indicated that there are anti-inflammatory, anticoagulation, and immunoregulatory effects of moderate XBJ in animal models of sepsis.

In patients with sepsis, independent meta-analysis found significant association with XBJ use; however, the small sample sizes and limited methodological quality may have affected the robustness and credibility of these findings.

All of these factors were successfully implemented in the current trial. One of the main results of our study was the similar rate of AEs in the XBJ group compared with the placebo group.

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