Back to resultsThe Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function Failure
Primary Purpose
Sepsis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Rheum Palmatum Root
Starch Corn
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Gastrointestinal dysfunction, sepsis, trauma
Eligibility Criteria
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
Sites / Locations
- Shanghai ChangZheng HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rheum Palmatum Root
Starch Corn
Arm Description
Rheum Palmatum Root is commercially certified rhubarb(Rheum palmatum ,Sichuan origin, provided by the pharmacy of my hospital)
Medical Starch is harmless to people
Outcomes
Primary Outcome Measures
The remission rate of gastrointestinal dysfunction
The rate of patients who can tolerate 1000Kcal whole protein enteral nutrition in all subjects
Secondary Outcome Measures
The ratios of L/M in human urine samples
The ratios oflactulose / mannitol in human urine samples
citrulline
The contents of citrulline in human serum samples
D- lactic acid
The contents of citrulline in human serum samples
Full Information
NCT ID
NCT03048903
First Posted
January 19, 2017
Last Updated
February 7, 2017
Sponsor
CHEN De-chang
Collaborators
RenJi Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03048903
Brief Title
The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function Failure
Official Title
The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CHEN De-chang
Collaborators
RenJi Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Gastrointestinal dysfunction, sepsis, trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomly divided into two groups ,using rheum palmatum or placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rheum Palmatum Root
Arm Type
Experimental
Arm Description
Rheum Palmatum Root is commercially certified rhubarb(Rheum palmatum ,Sichuan origin, provided by the pharmacy of my hospital)
Arm Title
Starch Corn
Arm Type
Placebo Comparator
Arm Description
Medical Starch is harmless to people
Intervention Type
Drug
Intervention Name(s)
Rheum Palmatum Root
Other Intervention Name(s)
Chinese Rhubarb Root
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Starch Corn
Other Intervention Name(s)
Medical Starch
Intervention Description
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.
Primary Outcome Measure Information:
Title
The remission rate of gastrointestinal dysfunction
Description
The rate of patients who can tolerate 1000Kcal whole protein enteral nutrition in all subjects
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
The ratios of L/M in human urine samples
Description
The ratios oflactulose / mannitol in human urine samples
Time Frame
7 days
Title
citrulline
Description
The contents of citrulline in human serum samples
Time Frame
7 days
Title
D- lactic acid
Description
The contents of citrulline in human serum samples
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHEN De chang, doctor
Phone
8618918520002
Email
18918520002@189.cn
Facility Information:
Facility Name
Shanghai ChangZheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changzhen Hospital
Phone
021-81886999
Email
15902152684@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22985725
Citation
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.
Results Reference
result
Learn more about this trial
The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function Failure
We'll reach out to this number within 24 hrs