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A multi-center, randomized, double-blind, placebo-controlled clinical study on the treatment of pediatric anorexia (spleen deficiency and food stagnation syndrome) with Shanpu Jianpi Granules

A multi-center, randomized, double-blind, placebo-controlled clinical study on the treatment of pediatric anorexia (spleen deficiency and food stagnation syndrome) with Shanpu Jianpi Granules

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001689
Enrollment
Unknown
Registered
2026-07-06
Start date
2025-06-21
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

infantile anorexia

Interventions

observation group:Shanpu Jianpi Granules
control group:Placebo simulation particles

Sponsors

Affiliated Hospital of Liaoning University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for anorexia in both traditional Chinese medicine and Western medicine; 2. The traditional Chinese medicine diagnosis is spleen deficiency and food stagnation syndrome; 3. Aged 1 to 14 years old (=14 years old), with no gender restrictions; 4. Agree to cooperate with medication and accept evaluation according to the requirements of the trial protocol; 5. The informed consent of the subject's legal guardian must be obtained and the informed consent form must be voluntarily signed; when the subject is capable of making decisions about participating in clinical trials, the consent of the subject himself/herself must also be obtained. Those who do not meet any of the above conditions shall not be selected as subjects.

Exclusion criteria

Exclusion criteria: 1. Anorexia caused by disease impacts, such as acute and chronic gastroenteritis, peptic ulcer, respiratory infection, acute and chronic hepatitis, anorexia nervosa, and anorexia induced by certain medications; 2. Moderate to severe malnutrition; 3. Allergic to the ingredients of Shanpu Jianpi Granules; 4. Presence of severe primary diseases in cardiovascular, neurological, respiratory, hepatobiliary, urinary systems, etc; 5. Mental disorders, intellectual disabilities, and/or communication disorders; 6. Participants who have participated in other clinical trials within the first 3 months prior to the trial; 7. Individuals whom the researchers deem unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The total effective rate ;Overall symptom score;Recurrence situation;

Secondary

MeasureTime frame
Disappearance rate of individual symptoms;Significant efficacy rate of individual symptoms;Scores for individual symptoms;Traditional Chinese Medicine (TCM) syndrome score;Growth and nutritional status indicators (height, weight, body mass index);

Countries

China

Contacts

Public ContactWang xuefeng

Affiliated Hospital of Liaoning University of Chinese Medicine

lnzywxf@163.com13840208807

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026