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A multicenter randomized controlled clinical study on the treatment of functional dyspepsia (spleen stomach qi deficiency syndrome) in children with anorexia Kang granules

A multicenter randomized controlled clinical study on the treatment of functional dyspepsia (spleen stomach qi deficiency syndrome) in children with anorexia Kang granules

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000439
Enrollment
Unknown
Registered
2025-02-28
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

functional dyspepsia

Interventions

test group:Anorexia Kang Granules
control group:Cypermethrin hydrochloride tablets

Sponsors

Liaoning University of Traditional Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Meets the Western and Traditional Chinese Medicine diagnostic criteria for pediatric FD; (2) Age range: 1-14 years old (= 14 years old) without gender restrictions; (3) The informed consent of the legal guardian of the subject must be obtained and a voluntary informed consent form must be signed; When participants are able to make decisions to participate in clinical trials their consent must also be obtained. (4) During the 2-week screening period no medication related to digestive disorders was used good dietary habits were established and FD symptoms still exist.

Exclusion criteria

Exclusion criteria: (1) Digestive disorders caused by organic diseases such as acute and chronic gastroenteritis peptic ulcers history of gastrointestinal surgery acute and chronic hepatitis anorexia nervosa and anorexia caused by certain medications; (2) Simultaneous treatment can cause constipation or increased gastrointestinal motility; (3) Moderate to severe malnutrition; (4) Serious primary diseases such as cardiovascular neurological respiratory hepatobiliary and urinary systems exist; (5) Mental disorders intellectual disabilities and/or communication disorders; (6) Allergic to the ingredients of Yanshuikang granules or cyproheptadine hydrochloride tablets; (7) Participated in clinical trials within the past 12 weeks; (8) Researchers believe that participants should not participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Total efficiency;

Secondary

MeasureTime frame
Number of gut microbiota;Gastrointestinal hormone levels;Clinical disappearance rate and significant efficacy rate of individual symptoms;Changes in Gastric Electrogram;Recurrence situation;Traditional Chinese Medicine Syndrome Points;The degree of improvement in weight and dietary time;Niping Digestive Dysfunction Index Scale;

Countries

China

Contacts

Public ContactWang Xuefeng

Liaoning University of Traditional Chinese Medicine Affiliated Hospital

lnzywxf@163.com13840208807

Outcome results

None listed

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