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

NCT ID: NCT03048903

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were randomly divided into two groups ,using rheum palmatum or placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rheum Palmatum Root

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

Group Type EXPERIMENTAL

Rheum Palmatum Root

Intervention Type DRUG

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

Medical Starch is harmless to people

Group Type PLACEBO_COMPARATOR

Starch Corn

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Chinese Rhubarb Root Medical Starch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role collaborator

CHEN De-chang

OTHER

Sponsor Role lead

Responsible Party

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CHEN De-chang

Director, Head of Intensive care unit, Principal Investigator, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shanghai ChangZheng Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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CHEN De chang, doctor

Role: CONTACT

8618918520002

Facility Contacts

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Changzhen Hospital

Role: primary

021-81886999

References

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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.

Reference Type RESULT
PMID: 22985725 (View on PubMed)

Other Identifiers

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SHCZHJJ01-CDC

Identifier Type: REGISTRY

Identifier Source: secondary_id

SHCZHJJ01

Identifier Type: -

Identifier Source: org_study_id

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