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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048903
• Other study ID #: SHCZHJJ01
• Secondary ID: SHCZHJJ01-CDC
• Status: Recruiting
• Phase: Phase 2
• First received: January 19, 2017
• Last updated: February 7, 2017
• Start date: February 2016
• Est. completion date: July 2018

Study information

• Verified date: February 2017
• Source: Shanghai Changzheng Hospital
• Contact: CHEN De chang, doctor
• Phone: 8618918520002
• Email: 18918520002[@]189.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai ChangZheng Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
CHEN De-chang	RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Tech — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The remission rate of gastrointestinal dysfunction	The rate of patients who can tolerate 1000Kcal whole protein enteral nutrition in all subjects	2 weeks
Secondary	The ratios of L/M in human urine samples	The ratios oflactulose / mannitol in human urine samples	7 days
Secondary	citrulline	The contents of citrulline in human serum samples	7 days
Secondary	D- lactic acid	The contents of citrulline in human serum samples	7 days