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Study on the Role and Mechanism of Shenling Baizhu Powder in Clostridioides difficile-associated Diarrhea in Severe Patients

Study on the Role and Mechanism of Shenling Baizhu Powder in Clostridioides difficile-associated Diarrhea in Severe Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001019
Enrollment
Unknown
Registered
2026-04-17
Start date
2025-06-01
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Clostridium difficile-Associated Diarrhea

Interventions

Study group:Shenling Baizhu Powder + Conventional Therapy
Control group:Conventional Therapy

Sponsors

The First Affiliated Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meets the Western medical diagnostic criteria for CDAD; (2) Diarrhea occurring during or after antibiotic use, with frequency =3 times/day, lasting at least 2 days, accompanied by changes in stool characteristics, and may include bloody stools, abdominal distension, abdominal pain, fever (=38°C), and elevated peripheral white blood cell count; (3) Stool smear microscopy reveals intestinal flora imbalance or predominant dominant bacteria (positive for cocci, bacilli, or fungi); (4) Exclude diarrhea caused by infectious diseases, functional disorders, or organic pathologies; (5) Meets the diagnostic criteria for spleen-stomach deficiency-cold syndrome (referencing the "Guidelines for Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Internal Medicine" established by the China Association of Chinese Medicine); (6) Age range: 18-70 years, gender unspecified; (7) Obtain the patient's signed informed consent form.

Exclusion criteria

Exclusion criteria: (1) Women planning to become pregnant, during pregnancy, or breastfeeding; (2) Patients with severe digestive system diseases that may cause diarrhea, such as irritable bowel syndrome, ulcerative colitis, or Crohn's disease; (3) Patients with malignant tumors, severe immune dysfunction, immunosuppression, or immunodeficiency; (4) Patients currently participating in other clinical drug trials.

Design outcomes

Primary

MeasureTime frame
Clinical remission rate;

Secondary

MeasureTime frame
Recurrence rate;

Countries

China

Contacts

Public ContactYuanyuan Zhao

The First Affiliated Hospital of Ningbo University

274082314@qq.com13566052649

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026