The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function Failure

Study Overview
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Brief Summary
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Random grouping by computer, divided into two groups, a group of rhubarb treatment group, another group for the placebo group.

Detailed Description
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Patients were randomly divided into two groups, using rhubarb powder or placebo. Rhubarb is commercially certified rhubarb(Rheum palmatum, Sichuan origin, provided by the pharmacy of my hospital), ground into a powder, over 80 mesh steel mesh, Two days before 6g, three times / day, oral or nasal feeding, two days later reduced to 3g, three times / day, oral or nasal feeding; Another group of patients taking placebo, with the same dose of Rhubarb; The overall course of the two drugs was a week.

Official Title
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The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function

Conditions
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Sepsis

Intervention / Treatment
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* Drug: Rheum Palmatum Root
* Drug: Starch Corn


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18-65 year old; Diagnosis: sepsis with gastrointestinal dysfunction (II-III grade AGI); gastrointestinal dysfunction after trauma (II-III AGI); Complete gastrointestinal tract anatomic structure（including the ileum and colon stoma） Exclusion Criteria: Hemodynamic instability; Underlying diseases: cardiac function III IV, chronic liver dysfunction Child-Pugh score >9 points; Less than 5 days after surgery for stomach and small intestine，less than 7 days after Colonic surgery, Postoperative gastrointestinal leakage; Abdominal Compartment Syndrome; mechanical ileus active gastrointestinal hemorrhage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomly divided into two groups ,using rheum palmatum or placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rheum Palmatum Root<br>Rheum Palmatum Root is commercially certified rhubarb(Rheum palmatum ,Sichuan origin, provided by the pharmacy of my hospital) | Drug: Rheum Palmatum Root<br>* Rhubarb is commercially certified rhubarb(Rheum palmatum , Sichuan origin, provided by the pharmacy of my hospital), ground into a powder, over 80 mesh steel mesh.The dose is 6g in the first 2 days, 3 times / day, oral or nasal feeding,two days later the dose is reduced to 3g, three times / day, oral or nasal feeding.<br>* Other names: Chinese Rhubarb Root;|
| Placebo Comparator: Starch Corn<br>Medical Starch is harmless to people | Drug: Starch Corn<br>* Starch Corn is harmless to people .The use dosage is same as Rheum Palmaturn Root.The dose is 6g in the first 2 days, 3 times / day, oral or nasal feeding,two days later the dose is reduced to 3g, three times / day, oral or nasal feeding.<br>* Other names: Medical Starch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The remission rate of gastrointestinal dysfunction | The rate of patients who can tolerate 1000Kcal whole protein enteral nutrition in all subjects | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratios of L/M in human urine samples | The ratios oflactulose / mannitol in human urine samples | 7 days | 
| citrulline | The contents of citrulline in human serum samples | 7 days | 
| D- lactic acid | The contents of citrulline in human serum samples | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal dysfunction, sepsis, trauma