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

Phase 2

• Conditions: Sepsis
• Interventions: Drug: Starch Corn; Drug: Rheum Palmatum Root

• Registration Number: NCT03048903
• Lead Sponsor: CHEN De-chang

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2017-01-19
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Study First Posted: 2017-02-09
• Last Update Posted: 2017-02-09
• Primary Completion: 2017-12
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Age:18-65 year old;
2. Diagnosis: sepsis with gastrointestinal dysfunction (II-III grade AGI); gastrointestinal dysfunction after trauma (II-III AGI);
3. Complete gastrointestinal tract anatomic structure（including the ileum and colon stoma）

Exclusion Criteria

1. Hemodynamic instability;
2. Underlying diseases: cardiac function III~IV, chronic liver dysfunction Child-Pugh score >9 points;
3. Less than 5 days after surgery for stomach and small intestine，less than 7 days after Colonic surgery, Postoperative gastrointestinal leakage;
4. Abdominal Compartment Syndrome;
5. mechanical ileus
6. active gastrointestinal hemorrhage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Starch Corn	Starch Corn	Medical Starch is harmless to people
Rheum Palmatum Root	Rheum Palmatum Root	Rheum Palmatum Root is commercially certified rhubarb(Rheum palmatum ,Sichuan origin, provided by the pharmacy of my hospital)

Primary Outcome Measures

Name	Time	Method
The remission rate of gastrointestinal dysfunction	2 weeks	The rate of patients who can tolerate 1000Kcal whole protein enteral nutrition in all subjects

Secondary Outcome Measures

Name	Time	Method
The ratios of L/M in human urine samples	7 days	The ratios oflactulose / mannitol in human urine samples
D- lactic acid	7 days	The contents of citrulline in human serum samples
citrulline	7 days	The contents of citrulline in human serum samples

Trial Locations

Locations (1)

Shanghai ChangZheng Hospital; 🇨🇳 Shanghai, Shanghai, China