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Real-World Data Research on the Clinical Application of Spleen-Invigorating and Stomach-Harmonizing Chinese Patent Medicines Based on Traditional Chinese Medicine Syndrome Differentiation

Real-World Data Research on the Clinical Application of Spleen-Invigorating and Stomach-Harmonizing Chinese Patent Medicines Based on Traditional Chinese Medicine Syndrome Differentiation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001224
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-05-18
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Spleen Deficiency Syndrome / Food Stagnation Syndrome / Distention and Fullness, and other Spleen-Stomach Related Diseases

Interventions

TCM Syndrome Type:The prescribed medication includes Chinese patent medicines for invigorating the spleen and harmonizing the stomach.

Sponsors

Chengdu Women's and Children's Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.Pediatric patients aged 0–18 years.2.Meeting the aforementioned diagnostic criteria for TCM syndrome differentiation (any one type) and Western medicine diagnostic criteria.3.The prescription includes at least one Chinese patent medicine for invigorating the spleen and harmonizing the stomach (e.g., Xiao'er Jianpi Wan, Shenling Baizhu San, Jianpi Xiaoshi Wan, Buzhong Yiqi Wan, etc.).4.The date of consultation is between January 1, 2023, and December 31, 2024.5.Complete electronic medical records and prescription information, including no missing key data such as age, gender, body weight, BMI, TCM syndrome type, Western medicine diagnosis, drug name, usage and dosage, date of consultation, records of efficacy-related symptoms, and results of safety-related examinations (e.g., liver and kidney function, blood routine).

Exclusion criteria

Exclusion criteria: 1.Patients with a history of allergy to any spleen-invigorating and stomach-harmonizing Chinese patent medicine or its ingredients in the prescription.2.Patients complicated with severe organic diseases such as severe hepatic and renal insufficiency, cardiovascular and cerebrovascular diseases, hematological diseases, or immune system diseases.3.Patients with active infectious diseases (e.g., acute gastroenteritis, pneumonia caused by bacterial or viral infection).4.Patients for whom the TCM syndrome type is not clearly defined or the syndrome differentiation description is ambiguous and cannot be accurately classified in the prescription.5.Prescriptions with incomplete records of drug usage and dosage (e.g., no indication of dosage, frequency, or course of treatment) or irrational prescriptions.6.For repeated visits with highly duplicated prescription information (e.g., multiple follow-up records of the same patient with the same diagnosis and the same medication regimen), only the data from the first visit will be retained, and the rest will be excluded.

Design outcomes

Primary

MeasureTime frame
Condition of symptom improvement;Changes in symptom score;Clinical outcome;

Secondary

MeasureTime frame
Incidence of adverse reactions;Laboratory parameters;

Countries

China

Contacts

Public ContactYi Deng

Chengdu Women's and Children's Central Hospital

9306179@qq.com028-61866157

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026