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Study for clinical efficacy evaluation and mechanism of Chinese medicine in relieving antibiotic resistance and sensitizing resistant bacteria by taking drug-resistant bacterial diarrhea as an example

Study for clinical efficacy evaluation and mechanism of Chinese medicine in relieving antibiotic resistance and sensitizing resistant bacteria by taking drug-resistant bacterial diarrhea as an example

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027915
Enrollment
Unknown
Registered
2019-12-04
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

Drug-resistant bacterial diarrhea in children

Interventions

Sponsors

Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Aged 6 months to 14 years old; 2. In line with the diagnostic standards of traditional Chinese and western medicine, the course of the disease is less than 2 weeks, and the disease is mild and medium; Diagnostic criteria of western medicine: refer to the 8th edition of Zhu futang Practical Pediatrics in 2015 and Clinical Practice Guide for Acute Infectious Diarrheal Disease in Chinese Children formulated by Digestive Group of Pediatrics Branch of Chinese Medical Association in 2016. If drug-resistant bacteria are found in fecal culture, it is drug-resistant bacterial diarrhea.Diagnostic criteria of Traditional Chinese Medicine: the relevant criteria for diarrhea, dampness and heat syndrome in children are formulated with reference to Pediatrics of Praditional Chinese Medicine, the 4th edition of the 13th Five-year New Century, 2016. 3. White blood cell count >=5 /HPF in routine test, accompanied by the determination of procalcitonin or CRP or the percentage of neutrophils is higher than normal; 4. Get the guardian's consent, fill in the informed consent form, and agree to participate in (children over 8 years old should sign the consent form).

Exclusion criteria

Exclusion criteria: 1. Bacterial diarrhea caused by cholera, dysentery, typhoid and paratyphoid (white blood cell count in stool >=15 /HPF, a small number of red blood cells can be seen); 2. Severe dehydration, acidosis, shock, and immunodeficiency; 3. Patients with serious diseases of cardiovascular, liver, kidney and hematopoietic system and mental illness; 4. Acute diarrhea caused by intussusception and intestinal polyps; 5. Patients who underwent surgery within 30 days before the test and caused diarrhea; 6. Patients who failed to respond to treatment will be not included in this study; 7. Patients who participated in other clinical trials within 1 months; 8. Allergic constitution or be allergy to known components of the test drug. Patients who meet any of the above criteria should be excluded.

Design outcomes

Primary

MeasureTime frame
Antibiotic use rate;Cure rate;

Secondary

MeasureTime frame
Time of delaying antibiotic intervention;Effective rate;Period of treatment;

Countries

China

Contacts

Public ContactYanjing Liu

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

2785118375@qq.com+86 13180896245

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026