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A randomized, double-blind, very low dose, parallel controlled, multicenter Phase II clinical study to explore the efficacy and safety of HC001 granules in the treatment of acute watery diarrhea in children (damp-heat syndrome)

A randomized, double-blind, very low dose, parallel controlled, multicenter Phase II clinical study to explore the efficacy and safety of HC001 granules in the treatment of acute watery diarrhea in children (damp-heat syndrome)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078392
Enrollment
Unknown
Registered
2023-12-07
Start date
2022-12-03
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Acute watery diarrhea in children (Damp-heat syndrome)

Interventions

Experimental:HC001 granule
Control:Very low dose HC001 granules

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1 It is consistent with the Western diagnostic standard of acute watery diarrhea in children and the TCM syndrome differentiation standard of damp-heat syndrome 2 Stool characteristics were Bristol-grade 7 or 6 3 The course of diarrhea is less than 72 hours, and the disease is mild or medium 4 Age 1-5 years old (< 6 years old) 5 The informed consent process shall be in accordance with the regulations, and the legal guardian of the tested child will sign the informed consent voluntarily

Exclusion criteria

Exclusion criteria: 1 Acute diarrhea severe, or frequent vomiting unable to ingest diet 2 Watery diarrhoea due to other causes, such as primary lactase deficiency, glucose-galactose malabsorption, chlorinated diarrhoea, primary bile acid malabsorption, etc., or food protein-induced enteropathy, or due to specific pathogenic agents (e.g. cholera) 3 Dysentery diarrhea (naked mucus, pus and blood stool), or stool microscopic examination found pus/white blood cells =5 /HP and/or red blood cells =3 /HP 4 Symptomatic diarrhea, or antibiotic-associated diarrhea, or diarrhea caused by food poisoning 5 Patients with severe primary diseases of heart, liver, kidney, digestive and hematopoietic systems, or severe malnutrition 6 Allergic to the experimental drug and its ingredients 7 The researchers did not consider it suitable for induction

Design outcomes

Primary

MeasureTime frame
Efficacy of diarrhea(Total effective rate and Marked effective rate);Onset time of antidiarrhea(hours);Curative effect of TCM syndrome;Continuous time of diarrhea/ time of antidiarrhea(hours);

Countries

China

Contacts

Public ContactZailing Li

Peking University Third Hospital

topbj163@sina.com+86 10 8226 5573

Outcome results

None listed

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