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

CHEN De-chang

Status and phase: Unknown; Phase 2

Conditions: Sepsis

Treatments: Drug: Starch Corn; Drug: Rheum Palmatum Root

Study type: Interventional

Funder types: Other

Identifiers

NCT03048903

SHCZHJJ01-CDC (Registry Identifier)

SHCZHJJ01

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Rheum Palmatum Root

Experimental group

Description:

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

Treatment:

Drug: Rheum Palmatum Root

Starch Corn

Placebo Comparator group

Description:

Medical Starch is harmless to people

Treatment:

Drug: Starch Corn