SepsisPhase 2NCT03048903
The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function Failure
A Phase 2 study testing Rheum Palmatum Root and Starch Corn in people with Sepsis, run by CHEN De-chang at 1 site in China.
Trial summary
Random grouping by computer, divided into two groups, a group of rhubarb treatment group, another group for the placebo group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Rheum Palmatum Root and Starch Corn
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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）
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai ChangZheng Hospital
Shanghai, Shanghai Municipality, 200000
Changzhen Hospital, 021-81886999, 15902152684@163.com
About this study
Official title: The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function
Random grouping by computer, divided into two groups, a group of rhubarb treatment group, another group for the placebo group.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Rheum Palmatum Root, Starch Corn
- Keywords
- Gastrointestinal dysfunction, sepsis, trauma
- Medical subject headings
- Sepsis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheum Palmatum RootDrug
Also called Chinese Rhubarb 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 CornDrug
Also called Medical Starch
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.
| Study group | Role | What they receive |
|---|---|---|
| Rheum Palmatum Root | Experimental | Rheum Palmatum Root is commercially certified rhubarb(Rheum palmatum ,Sichuan origin, provided by the pharmacy of my hospital) Receives: Drug: Rheum Palmatum Root |
| Starch Corn | Placebo comparator | Medical Starch is harmless to people Receives: Drug: Starch Corn |
What is being measured
The primary outcome is the main question the study is designed to answer.
The remission rate of gastrointestinal dysfunction
The rate of patients who can tolerate 1000Kcal whole protein enteral nutrition in all subjects
Measured: 2 weeks
Secondary outcomes (3)
The ratios of L/M in human urine samples
The ratios oflactulose / mannitol in human urine samples
Measured: 7 days
citrulline
The contents of citrulline in human serum samples
Measured: 7 days
D- lactic acid
The contents of citrulline in human serum samples
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startFeb 2016
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly divided into two groups ,using rheum palmatum or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHEN De-chang
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Sponsor-investigator, CHEN De-chang, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048903
- Sponsor's protocol ID
- SHCZHJJ01
- Other IDs
- SHCZHJJ01-CDC
- Status last verified
- Feb 2017
- First submitted
- 19 Jan 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22985725
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function
- ClinicalTrials.gov ID
- NCT03048903
- Acronym / sponsor ID
- SHCZHJJ01
- Conditions
- Sepsis
- Keywords
- Gastrointestinal dysfunction, sepsis, trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- CHEN De-changUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly divided into two groups ,using rheum palmatum or placebo
| Arm | Type | Receives |
|---|---|---|
| Rheum Palmatum Root | Experimental | Drug: Rheum Palmatum RootRheum Palmatum Root is commercially certified rhubarb(Rheum palmatum ,Sichuan origin, provided by the pharmacy of my hospital) |
| Starch Corn | Placebo comparator | Drug: Starch CornMedical Starch is harmless to people |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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）
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rheum Palmatum RootAlso: Chinese Rhubarb RootRhubarb 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. | Drug | Rheum Palmatum Root |
| Starch CornAlso: Medical StarchStarch 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. | Drug | Starch Corn |
Primary outcome
The remission rate of gastrointestinal dysfunction
Time frame: 2 weeks
The rate of patients who can tolerate 1000Kcal whole protein enteral nutrition in all subjects
3 secondary outcomes
The ratios of L/M in human urine samples
Time frame: 7 days
citrulline
Time frame: 7 days
D- lactic acid
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Results publication: PubMed 22985725Kubica 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rheum Palmatum Root and Starch Corn in people with Sepsis, run by CHEN De-chang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHEN De chang, doctor (8618918520002, 18918520002@189.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The remission rate of gastrointestinal dysfunction (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048903, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.