WenChang TongFu Formula for Acute Gastrointestinal Injury in critically ill patients: A Multiple-Center,Double-Blind, Placebo-Controlled Randomized Controlled Trial

Clinical efficacy evaluation of integrated traditional Chinese and Western medicine in the treatment of patients with acute gastrointestinal function injury

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073342

Enrollment

Unknown

Registered

2023-07-07

Start date

2023-08-01

Completion date

Unknown

Last updated

2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gastrointestinal Injury

Interventions

Treatment group:On the basis of conventional Western medicine treatment, add oral/nasal feeding of WenChang TongFu Formula, once every 6 hours

And enema with WenChang TongFu Formula, once every 6 hours

control group:On the basis of conventional Western medicine treatment, add oral/nasal feeding of Placebo, once every 6 hours

And enema with Placebo, once every 6 hours

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 18-80 years; (2) Conforming to the diagnostic criteria for acute gastrointestinal functional injury of level II - III; (3) Meets the diagnostic criteria for the syndrome type of "yang deficiency of spleen and kidney, obstruction of fu qi" in traditional Chinese medicine (4) Informed consent to the treatment plan for this study.

Exclusion criteria

Exclusion criteria: (1) Expected ICU stay<3 days; (2) Pregnant or lactating women, those with fertility requirements in the past six months; (3) Those with advanced malignant tumors and an expected lifespan of less than 90 days; (4) Those with severe digestive system diseases (such as acute gastrointestinal bleeding, mechanical intestinal obstruction, abdominal surgery, abdominal compartment syndrome) who are unable to receive treatment medication through the gastrointestinal tract; (5) Patients with unstable hemodynamics who cannot guarantee the administration of therapeutic drugs through the gastrointestinal tract; (6) Participants in other clinical trials

Design outcomes

Primary

Measure	Time frame
intra-abdominal pressure;	—

Secondary

Measure	Time frame
traditional Chinese medicine syndrome score;Ultrasound cross-sectional area of gastric antrum;Score sheet of acute gastrointestinal injury ultrasonography;Gastrointestinal Dysfunction Score;	—

Countries

China

Contacts

Public ContactSong Zhang

Hospital of Chengdu University of Traditional Chinese Medicine

153382179@qq.com+86 138 8091 1582

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026