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

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

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

Study Overview

• Status: Unknown
• Conditions: Sepsis
• Intervention / Treatment: Drug: Rheum Palmatum Root; Drug: Starch Corn

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: CHEN De chang, doctor; Phone Number: 8618918520002; Email: 18918520002@189.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai ChangZheng hospital
      • Contact: Changzhen Hospital; Phone Number: 021-81886999; Email: 15902152684@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rheum Palmatum Root; Rheum Palmatum Root is commercially certified rhubarb(Rheum palmatum ,Sichuan origin, provided by the pharmacy of my hospital)	Drug: Rheum Palmatum Root; 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.; Other Names: Chinese Rhubarb Root
Placebo Comparator: Starch Corn; Medical Starch is harmless to people	Drug: Starch Corn; 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.; Other Names: Medical Starch

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CHEN De-chang
• Collaborators: RenJi Hospital

Publications and helpful links

General Publications

• Kubica P, Kot-Wasik A, Wasik A, Namiesnik J, Landowski P. Modern approach for determination of lactulose, mannitol and sucrose in human urine using HPLC-MS/MS for the studies of intestinal and upper digestive tract permeability. J Chromatogr B Analyt Technol Biomed Life Sci. 2012 Oct 15;907:34-40. doi: 10.1016/j.jchromb.2012.08.031. Epub 2012 Sep 4.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: trauma; sepsis; Gastrointestinal dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: SHCZHJJ01; SHCZHJJ01-CDC (Registry Identifier: CHEN De-chang)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO