A Phase 1/2 interventional study of Fuzheng Tongfu Jiedu prescription (FZTFJD) and Placebo in Sepsis Abdominal, Gastrointestinal Dysfunction and Traditional Chinese Medicine, sponsored by Dongzhimen Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Dongzhimen Hospital, Beijing · Phase 1/2, Interventional, and Treatment
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Among 22 studies in Intraabdominal Infections with a site in China — 6 open to participants now, 6 under way, 1 of them phase 3. Intraabdominal Infections · China.
Among the 22 studies in Intraabdominal Infections with a site in China, this one is the 15th largest by planned enrollment of the 17 interventional ones that give a count, is one of 2 that started in 2025, is the only one in phase 1/2, and was the 20th registered.
129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.
Browse Intraabdominal Infections studies →6 of the 22 studies in Intraabdominal Infections with a site in China are open now. Recruiting first, the newest first:
Shanghai Zhongshan Hospital · Sites in China
Ages 18+
Joincare Pharmaceutical Group Industry Co., Ltd · Sites in China
Ages 18–45 · Healthy volunteers
Shanghai Zhongshan Hospital · Sites in China
Ages 18–100
Qilu Pharmaceutical Co., Ltd. · Sites in China
Ages 18–75
RenJi Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 10 Intraabdominal Infections studies recruiting now, 6 (60%) set no upper age limit and 3 (30%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 50 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 6 · Phase 4 5
First in 2005; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is below the median of 140 across 77 interventional studies indexed under Intraabdominal Infections.
Median enrollment 268 across the 17 interventional studies, 100 across the 5 observational. Of the 12 that completed or were terminated, 5 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 22 have an industry lead sponsor. The 10 most frequent:
Dongzhimen Hospital, Beijing is the lead sponsor of 45 studies on the registry; 19 are open to participants now.
Dongzhimen Hospital, Beijing has 1 study filed under Intraabdominal Infections — fewer than ten, so there is no comparison to draw.
3 of the studies in Intraabdominal Infections with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06633718Phase 3Qilu Pharmaceutical Co., Ltd.Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI | 2027-05-30 |
| NCT06504316RenJi HospitalOXiris for Abdominal SEptic Shock (OASES Study) | 2027-03-31 |
| NCT06304779Shanghai Zhongshan HospitalThe Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI | 2027-09-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 22 studies in Intraabdominal Infections with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study is a single-center, randomized, double-blind, placebo-controlled trial.
The study is designed to evaluate efficacy and safety of FZTFJD for treating gastrointestinal dysfunction associated with sepsis compared to placebo in combination with conventional western medicine treatment. Participants included in this study are diagnosed with sepsis-induced gastrointestinal dysfunction classified as Acute gastrointestinal injury (AGI)grades I-III. A total of seventy patients will be randomly assigned in a 1:1 ratio to receive either FZTFJD or placebo. The study encompasses a treatment duration of seven days followed by a twenty-one-day safety follow-up period. The AGI grade as the primary outcome measure will be assessed, while gut symptom score, abdominal pressure and circumference, SOFA and APACHE II scores, inflammation level as well as intestinal barrier function will serve as secondary outcome measures. Additionally, length of ICU stay and 28-day mortality will be included as prognostic indicators in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Basic treatment + Fuzheng Tongfu Jiedu prescription
Drug: Fuzheng Tongfu Jiedu prescription (FZTFJD)
Basic treatment + Fuzheng Tongfu Jiedu prescription placebo
Drug: Placebo
Fuzheng Tongfu Jiedu prescription (FZTFJD), a kind of Traditional Chinese medicine (TCM).Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.
Also known as: Conventional Western medical treatment
Fuzheng Tongfu Jiedu prescription plaebo. Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.
Also known as: Conventional Western medical treatment
AGI grade
As a predictor of mortality in critically ill patients, AGI grade is useful for identifying the severity of GI dysfunction. AGI grade refers to the diagnostic criteria for acute gastrointestinal injury established by the European Critical Care Society in 2012. AGI can be graded from a minimum of I to a maximum of IV. The higher the level, the more severe the gastrointestinal dysfunctionHigher AGI grade levels indicate progressively more severe conditions.
Time frame: Day0, Day3,Day7,Day14
Gastrointestinal symptoms score
The gastrointestinal symptoms score will be assessed by GSRS scale. The total score of the GSRS scale ranges from 0 to 78, with higher scores indicating more severe gastrointestinal symptoms.
Time frame: Day0, Day3,Day7,Day14
Abdominal pressure
Abdominal pressure is measured by bladder pressure which is measured by water column method.Higher abdominal pressure levels indicate progressively more severe conditions.
Time frame: Day0, Day3,Day7,Day14
Abdominal circumference
At the end of exhalation and before the beginning of inhalation, the abdominal circumference through the center of the umbilical cord was measured with a soft ruler.
Time frame: Day0, Day3,Day7,Day14
Blood routine
Blood routine test will be determined by blood cell analyzer.White blood cells higher or lower than normal indicate a septic inflammatory state.
Time frame: Day0, Day3,Day7,Day14
CRP
Expression levels of C-reactive proteins will be measured by Elida kit. The higher the level, the higher the sepsis inflammation.
Time frame: Day0, Day3,Day7,Day14
PCT
Expression levels of Procalcitonin will be measured with a specific kit. The higher the level, the higher the sepsis inflammation.
Time frame: Day0, Day3,Day7,Day14
Immune index-T cell functional subsets
The expression level of T cell functional subsets was detected
Time frame: Day0,Day7
Immune index-lymphocyte subsets
The expression level of lymphocyte subsets was detected
Time frame: Day0, Day7
Intestinal barrier function-diamine oxidase（DAO）
DAO is an important marker of intestinal mucosal integrity, and its activity level can reflect the strength of intestinal barrier function. When the gut is damaged, DAO is released into the blood, resulting in elevated DAO levels in the blood.The expression level of DAO in serum will be deteceed by the Eliasa kit.
Time frame: Day0, Day7
Intestinal barrier function-D-lactic acid level
The expression level of serum D-lactic acid will be measured by a specific Elisa kit. D-lactic acid is produced by bacteria in the gastrointestinal tract and then absorbed into the bloodstream. An increase of D-lactic acid indicates increased damage to the intestinal barrier and increased intestinal permeability in patients with sepsis.
Time frame: Day0, Day7
Intestinal barrier function--intestinal type Fatty acid Binding Protein (FABP)
Serum midgut fatty acid-binding protein (I-FABP) expression levels will be detected by a specific elisa kit. I-FABP is located in the cytoplasm of mature intestinal cells in the small intestinal villi, and ischemia of the intestinal villi can release I-FABP into the blood circulation. The increase of I-FABP in serum indicates increased intestinal ischemia.
Time frame: Day0、 Day7
Intestinal barrier function-Citrulline (CIT)
Since citrulline is mostly synthesized in intestinal mucosal epithelial cells, the number and function of intestinal mucosal epithelial cells can be evaluated by detecting the serum citrulline concentration. Therefore, monitoring the serum citrulline concentration can evaluate the intestinal function and the severity of intestinal dysfunction in critically ill patients.The expression level of CIT level in serum will be deteceed by the Eliasa kit.Since citrulline is mostly synthesized in intestinal mucosal epithelial cells, the number and function of intestinal mucosal epithelial cells can be evaluated by detecting the serum citrulline concentration. The decrease of serum citrulline level can reflect the decrease of intestinal mucosal epithelial cells.
Time frame: Day0、 Day7
Severity of sepsis-SOFA score
The score of SOFA will be assessed according to the SOFA scale. The total SOFA score is derived by adding the scores of the six organ systems and ranges from 0 to 24 points. The higher the score, the more severe the patient's organ dysfunction and the worse the prognosis.
Time frame: Day0、 Day3、Day7、Day14
Severity of sepsis-APACHE Ⅱ
The score of APACHE Ⅱ will be assessed according to the APACHE Ⅱ scale. The APACHEⅡ scoring system is composed of acute physiology score (APS), age score, and three parts. The final score is the sum of the three parts. The maximum theoretical score is 71, the higher the score, the more severe the disease.
Time frame: Day0、 Day3、Day7、Day14
Length of ICU stay
The length of ICU stay is closely related to sepsis condition, prognosis and medical expenditure. The longer the ICU stay, the worse the prognosis and the higher the medical expenditure.
Time frame: Day28
28-day mortality
The 28-day mortality rate intuitively reflects the prognosis of sepsis.
Time frame: Day28
Safety index-Blood routine
Blood routine will be detected by test kit.
Time frame: Day0、 Day3、Day7、Day14
Safety index-liver function
The indexes related to liver function metabolism, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil), direct and indirect bilirubin, albumin, prealbumin and cholinesterase, will be detected by biochemical test
Time frame: Day0、 Day3、Day7、Day14
Safety index-Renal function
Renal function test will be detected by test kit.
Time frame: Day0、 Day3、Day7、Day14
Safety index-Stool routine
Stool routine will be detected by test kit.
Time frame: Day0、 Day3、Day7、Day14
Adverse event
Adverse event
Time frame: Record any abnormality during the intervention.
Mechanism discussion-mtDNA
The expression level of mtDNA in seum will be detected by test kit.
Time frame: Day0、 Day7
Mechanism discussion-NLRP3
The expression level of NLRP3 in seum will be detected by test kit.
Time frame: Day0、 Day7
IL-1β
The expression level of IL-1β in seum will be detected by test kit.
Time frame: Day0、 Day7
IL-18
The expression level of IL-18 in seum will be detected by test kit.
Time frame: Day0、 Day7
IL-17
The expression level of IL-17 in seum will be detected by test kit.
Time frame: Day0、 Day7
Plan to share: Yes — The results will be shared with sleep researchers, public, and relevant academic institutions through high-impact peer-reviewed publications.
Supporting information: Study protocol, Clinical study report
Time frame: Six months after the end of the study
Access criteria: ljhly05@163.com
No publications or documents are linked to this record.
Start is estimated for Apr 2025; primary completion for Jun 2026, 14 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Dongzhimen Hospital, Beijing