The Study of Dachengqi Decoction Combined With Probiotic L92 to Improve the Prognosis of Patients With Severe Abdominal Hypertension

August 17, 2020 updated by: Chengjing Gao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Patients with severe infections, wounds (burns), and severe pancreatitis often have abdominal hypertension (IAH), which is an important objective manifestation of acute gastrointestinal failure in severe patients. Timely diagnosis and effective intervention can improve the treatment rate of patients. In the early stage, we conducted clinical exploration and observational research on the treatment of IAH with Dachengqi Decoction and Lactobacillus in the treatment of critically ill patients including the above diseases, and achieved significant clinical effects. On this basis, it is planned to verify the protective effect of Lactobacillus acidophilus L92, Dachengqi Decoction and the combination of the two on the gastrointestinal mucosal barrier function of patients with IAH and the regulation of the intestinal flora, and analyze the intestinal mucosal barrier The relationship between intestinal flora and the prognosis of IAH patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
752

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion and exclusion criteria and critically ill patients (acute severe pancreatitis, cervical spinal cord injury) who are 60 years old or older than 18 years old, expected to be mechanically ventilated in the ICU, and hospitalized for more than 48 hours, replaced intra-abdominal pressure monitoring with bladder pressure measurement, and repeated on admission The results of the three measurements are ≥12 mmHg.

Exclusion Criteria:

  • Patients who have not signed the informed consent; cannot tolerate intra-abdominal pressure monitoring; pregnant women; patients after bladder surgery; systemic diseases and recent use of related drugs; previous infections, such as history of tuberculosis or PPD positive; previous high History of blood pressure, poor blood pressure control (SBP/DBP>=140mmHg); patients with severe mental illness; long-term use of traditional Chinese medicine, probiotics, gastric mucosal protectors, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc., such as admission The drug was not discontinued within the previous month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Conventional treatment group
Control the primary disease, prevent infection, reduce gastrointestinal decompression, and actively maintain organ function.
Other: Conventional treatment
Conventional treatment
Experimental: Conventional treatment plus L92 group
Conventional treatment combined with L92
Other: Conventional treatment
Conventional treatment
Drug: probiotic L9
L92 2 tablets/time, tid, oral or nasal feeding
Experimental: Conventional treatment plus Dachengqi decoction group
Conventional treatment combined with Dachengqi Decoction
Other: Conventional treatment
Conventional treatment
Drug: Dachengqi decoction
Raw rhubarb 30g, Glauber's salt 30g, Citrus aurantium 20g, Magnolia officinalis 20g. The decoction was decocted uniformly in the decoction room of Xinhua Hospital, Shanghai Jiaotong University School of Medicine, and decocted 200 mL thickly, fed via nasogastric tube/nasal intestine tube and enema, 1 dose/d, and continued treatment until the end of the trial
Other Names:
  • probiotic L92
Experimental: Conventional treatment plus Dachengqi decoction plus L92 group
Conventional treatment combined with L92 and Dachengqi Decoction
Other: Conventional treatment
Conventional treatment
Drug: probiotic L9
L92 2 tablets/time, tid, oral or nasal feeding
Drug: Dachengqi decoction
Raw rhubarb 30g, Glauber's salt 30g, Citrus aurantium 20g, Magnolia officinalis 20g. The decoction was decocted uniformly in the decoction room of Xinhua Hospital, Shanghai Jiaotong University School of Medicine, and decocted 200 mL thickly, fed via nasogastric tube/nasal intestine tube and enema, 1 dose/d, and continued treatment until the end of the trial
Other Names:
  • probiotic L92

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of sepsis within 7 days
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XH-20-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dachengqi Decoction

Clinical Trials on Conventional treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings