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A prospective real-world study on the efficacy and safety of treating digestive tract symptoms in children with respiratory tract infections

A prospective real-world study on the efficacy and safety of treating digestive tract symptoms in children with respiratory tract infections

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114578
Enrollment
Unknown
Registered
2025-12-15
Start date
2025-12-15
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Children who have been clinically diagnosed with respiratory infection diseases and also have digestive tract symptoms such as anorexia, abdominal distension, and diarrhea (with the syndrome of spleen and stomach deficiency in traditional Chinese medicine)

Interventions

Chinese patent medicine group (conventional treatment + Shenqu decoction oral liquid):NA
Control group (conventional treatment):NA

Sponsors

Maternal and Child Health Hospital of Hubei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Age between 1 and 14 years old, regardless of gender. 2. Children clinically diagnosed with respiratory tract infection disease and accompanied by anorexia, abdominal distension, diarrhea and other gastrointestinal symptoms (TCM syndrome of spleen and stomach weakness. 3. Complete treatment records, including gastrointestinal symptoms and treatment regimens.

Exclusion criteria

Exclusion criteria: 1. Concomitant use of other medications that may aggravate respiratory or digestive symptoms. 2. Organic gastrointestinal diseases. 3. Complicated with other serious diseases (severe liver and kidney dysfunction, cancer, etc.); 4. Children with severe underlying diseases (e.g., congenital malformations) or immunodeficiency. 5. Children with allergy or intolerance to Chinese patent medicine, probiotics or antibiotics. 6. Children who did not cooperate with the treatment regimen.

Design outcomes

Primary

MeasureTime frame
The improvement rate of gastrointestinal symptoms;

Secondary

MeasureTime frame
Gastrointestinal function indexes (gastrin, motilin);Inflammatory markers: C-reactive protein (CRP), white blood cell count (WBC);The proportion of children in each group who had any adverse reactions during treatment, including but not limited to gastrointestinal discomfort, rash, allergic reactions, etc.;The severity of adverse reactions;The average remission time of gastrointestinal symptoms;

Countries

China

Contacts

Public ContactLi Wan

Maternal and Child Health Hospital of Hubei Province

1027949621@qq.com+86 27 87169280

Outcome results

None listed

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