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The efficacy and safety of Xiao'er Huashi Oral Liquid for functional dyspepsia children (syndrome of internal heat stagnated from accumulated food): a randomized, double-blind, placebo-controlled, multi-center clinical trial

The efficacy and safety of Xiao'er Huashi Oral Liquid for functional dyspepsia children (syndrome of internal heat stagnated from accumulated food): a randomized, double-blind, placebo-controlled, multi-center clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003323
Enrollment
Unknown
Registered
2013-06-14
Start date
2013-07-08
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

functional dyspepsia in children

Interventions

treatment group:Xiao’er Huashi Oral Liquid
control group:Xiao’er Huashi Oral Liquid placebo

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Children with functional dyspepsia; 2. Patients with TCM syndrome of internal heat stagnated from accumulated food; 3. Aged 1 to 14 years; 4. No use of herbs/formulas for Stagnation-removing and heat-cleaning, as well as digestive drugs within three days; 5. Guardian submitted informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, brain, liver, kidney, endocrine, blood and other systemic diseases; 2. Allergic patients or those who are allergic to the test drug; 3. ALT or AST>1.5 times the upper limit of normal, blood urea nitrogen (BUN)>1.2 times the upper limit of normal, serum creatinine (Cr) >the upper limit of normal; 4. Intestinal stenosis caused by rectum, colon organic disease (such as cancer, inflammation, anal fissure, Crohn's disease, intestinal obstruction, adhesions, colon polyps, intestinal tuberculosis); 5. Disabled patients prescribed by law (blind, deaf, dumb , mental retardation , mental disorders) ; 6. Having participated in other clinical trials in the past 3 months.

Design outcomes

Primary

MeasureTime frame
primary clinical symptoms (abdominal fullness and distention, pain) improvement and disappearance rate;

Secondary

MeasureTime frame
effect of TCM syndrome;effect of other single symptoms;

Countries

China

Contacts

Public ContactSiyuan Hu
husiyuan1963@sina.com+86 022 27432275

Outcome results

None listed

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