NCT03048903

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_2 sepsis

Timeline
Completed

Started Feb 2016

Typical duration for phase_2 sepsis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

January 19, 2017

Last Update Submit

February 7, 2017

Conditions

Sepsis

Keywords

Gastrointestinal dysfunctionsepsistrauma

Outcome Measures

Primary Outcomes (1)

  • The remission rate of gastrointestinal dysfunction

    The rate of patients who can tolerate 1000Kcal whole protein enteral nutrition in all subjects

    2 weeks

Secondary Outcomes (3)

  • The ratios of L/M in human urine samples

    7 days

  • citrulline

    7 days

  • D- lactic acid

    7 days

Study Arms (2)

Rheum Palmatum Root

EXPERIMENTAL

Rheum Palmatum Root is commercially certified rhubarb(Rheum palmatum ,Sichuan origin, provided by the pharmacy of my hospital)

Drug: Rheum Palmatum Root

Starch Corn

PLACEBO COMPARATOR

Medical Starch is harmless to people

Drug: Starch Corn

Interventions

Rheum Palmatum RootDRUG

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.

Also known as: Chinese Rhubarb Root
Rheum Palmatum Root
Starch CornDRUG

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.

Also known as: Medical Starch
Starch Corn

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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）

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai ChangZheng Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related 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 Technol Biomed Life Sci. 2012 Oct 15;907:34-40. doi: 10.1016/j.jchromb.2012.08.031. Epub 2012 Sep 4.

    PMID: 22985725RESULT

MeSH Terms

Conditions

SepsisWounds and Injuries

Interventions

Starch

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Central Study Contacts

CHEN De chang, doctor

CONTACT

861891852000218918520002@189.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients were randomly divided into two groups ,using rheum palmatum or placebo
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Head of Intensive care unit, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

January 19, 2017

First Posted

February 9, 2017

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Study Completion

July 1, 2018

Last Updated

February 9, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)