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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dachengqi Decoction Probiotic L92

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Conventional treatment group

Control the primary disease, prevent infection, reduce gastrointestinal decompression, and actively maintain organ function.

Group Type SHAM_COMPARATOR

Conventional treatment

Intervention Type OTHER

Conventional treatment

Conventional treatment plus L92 group

Conventional treatment combined with L92

Group Type EXPERIMENTAL

probiotic L9

Intervention Type DRUG

L92 2 tablets/time, tid, oral or nasal feeding

Conventional treatment

Intervention Type OTHER

Conventional treatment

Conventional treatment plus Dachengqi decoction group

Conventional treatment combined with Dachengqi Decoction

Group Type EXPERIMENTAL

Dachengqi decoction

Intervention Type DRUG

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

Conventional treatment

Intervention Type OTHER

Conventional treatment

Conventional treatment plus Dachengqi decoction plus L92 group

Conventional treatment combined with L92 and Dachengqi Decoction

Group Type EXPERIMENTAL

Dachengqi decoction

Intervention Type DRUG

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

probiotic L9

Intervention Type DRUG

L92 2 tablets/time, tid, oral or nasal feeding

Conventional treatment

Intervention Type OTHER

Conventional treatment

Interventions

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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

Intervention Type DRUG

probiotic L9

L92 2 tablets/time, tid, oral or nasal feeding

Intervention Type DRUG

Conventional treatment

Intervention Type OTHER

Other Intervention Names

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probiotic L92

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No