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Sea buckthorn syrup for the treatment of functional dyspepsia in children (milk food retention syndrome) Multicenter randomized controlled clinical study

Sea buckthorn syrup for the treatment of functional dyspepsia in children (milk food retention syndrome) Multicenter randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000498
Enrollment
Unknown
Registered
2025-03-10
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

Experimental group:Sea buckthorn syrup

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: Studies that meet all of the following criteria will be eligible for selection: (1) Meet the Western medicine diagnostic standards and Chinese medicine syndrome diagnostic standards for children with FD; (2) Age 1~14 years old (= 14 years old) no gender restrictions; (3) Informed consent must be obtained from the subject's legal guardian and voluntarily sign the informed consent form; When a subject is able to make a decision to participate in a clinical trial the consent of the subject must also be obtained. (4) During the 2-week screening period no drugs for the treatment of dyspepsia were used good eating habits had been established and FD symptoms still existed. Those who do not meet one of the above conditions will not be selected as subjects.

Exclusion criteria

Exclusion criteria: Studies that meet any of the following criteria are excluded: (1) Indigestion caused by organic diseases such as acute and chronic gastroenteritis peptic ulcer history of gastrointestinal surgery acute and chronic hepatitis anorexia nervosa anorexia caused by certain drugs; (2) Concurrent treatment can cause constipation or enhanced gastrointestinal motility; (3) moderate and severe malnutrition; (4) Presence of serious primary diseases such as cardiovascular nervous respiratory hepatobiliary urinary system etc.; (5) mental disability intellectual disability and/or communication disability; (6) Allergy to the components of sea buckthorn syrup or mosapride citrate oral solution; (7) Participated in a clinical trial within the past 12 weeks; (8) Those who are considered by the investigator to be inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Total effective rate at 2 weeks after randomization;

Secondary

MeasureTime frame
The disappearance rate and apparent efficiency of individual clinical symptoms;Gastrointestinal hormone levels;Recurrence situation;Changes in Gastric Electrogram;Untargeted metabolomics;The degree of reduction of the total symptom score, each individual symptom score and TCM syndrome score from baseline at each follow-up time point;Number of gut microbiota;TCM syndrome efficacy;Nipin Indigestion Index Scale;The degree of improvement in weight and eating time;

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