Acute bacterial infection-induced diarrhea (damp-heat syndrome)
Conditions
Interventions
Control Group:On the basis of conventional treatment, take oral Montmorillonite powder (Boehringer Ingelheim (Tianjin) Pharmaceutical Co., Ltd., National Drug Approval Number: T20526), 3 g per dose, t
Observation group:In addition to routine treatment, take Huanghou Zhi Xie dripping pills orally (produced by Anhui Leiyushang Pharmaceutical Co., Ltd., National Drug Approval Number: 230101), 12 pills
Sponsors
Nanjing Jiangning District Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Meets the criteria for bacterial diarrhea as outlined in the "Expert Consensus on the Diagnosis and Treatment of Infectious Diarrhea in Adults," with loose or watery stools =3 times within 24 hours, or accompanied by varying degrees of nausea, vomiting, abdominal pain, or fever, among other systemic symptoms. 2) Refers to the "Guidelines for Clinical Research of New Traditional Chinese Medicine (Trial)," with a traditional Chinese medicine diagnosis of damp-heat diarrhea syndrome (main symptoms: urgent diarrhea, abdominal pain preceding diarrhea; stools yellow-brown and foul-smelling; secondary symptoms: burning sensation around the anus; abdominal pain; irritability and thirst; short and red urine; yellow and greasy tongue coating, slippery and rapid pulse. One main symptom and two or more secondary symptoms are required for diagnosis). 3) Aged 18–75 years, with no gender restrictions. 4) Disease duration =72 hours. 5) Blood routine test results show white blood cell count >10×109/L, with an elevated proportion of neutrophils. 6) Stool microscopy reveals white blood cells and red blood cells. 7) Patients who are fully informed about the study and willing to cooperate with examinations and medication.
Exclusion criteria
Exclusion criteria: 1) Diarrhea caused by food poisoning. 2) Patients who have used antibiotics for treatment within one week prior to consultation. 3) Patients presenting with severe dehydration or critical conditions requiring ICU admission. 4) Patients with primary diseases such as cardiovascular, cerebrovascular, or hematological disorders. 5) Patients with liver function indicators exceeding 1.5 times the upper normal limit (AST or ALT or TBil > 1.5 times the upper normal value) and concurrent renal dysfunction. 6) Pregnant or intending-to-become-pregnant women, and breastfeeding women. 7) Patients with allergic constitutions or allergies to the investigational drug. 8) Patients with severe arrhythmias or arrhythmias requiring pharmacological treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total score of TCM syndrome scale after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical overall efficacy rate after treatment;Stool Consistency Typing Score (Bristol Stool Scale);Abdominal pain severity score (VAS score);The proportion of patients with abdominal pain resolution.;Serum C-reactive protein level;Serum procalcitonin level; | — |
Countries
China
Contacts
Public ContactZhu Wenhuan
Nanjing Jiangning District Traditional Chinese Medicine Hospital
Outcome results
None listed