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Clinical trial of Wang-Shi-Bao-Chi-Wan in the treatment of infantile functional dyspepsia syndrome

A randomized, double-blind, placebo-controlled multicenter clinical trial on the efficacy and safety of Wang-Shi-Bao-Chi-Wan in the treatment of infantile functional dyspepsia syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072543
Enrollment
Unknown
Registered
2023-06-16
Start date
2021-11-22
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Infantile functional dyspepsia syndrome

Interventions

Test drug group:Wangshibaochiwan
placebo group:Wangshibaochiwan Simulator (containing 10% crude drug)

Sponsors

Guangzhou Women and children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 3 Years

Inclusion criteria

Inclusion criteria: For a qualified child subject, the answer to all inclusion criteria must be "yes": (1) Children with functional dyspepsia syndrome in infants; (2) Children aged 1-36 months; (3) Children who have not used other drugs for dyspepsia in recent 1 week; (4) The informed consent process complies with the regulations, and the parents or guardians sign the informed consent form.

Exclusion criteria

Exclusion criteria: For a qualified child subject, the answer to all exclusion criteria must be "no": (1) There are digestive tract organic diseases such as peptic ulcer, gastrointestinal tumor, inflammatory bowel disease, pancreatitis and intestinal tuberculosis; (2) Suffering from serious heart, brain, liver, kidney, hematopoietic system, connective tissue diseases, endocrine diseases, and mental diseases; (3) Children with severe malnutrition; (4) Children who are using or need to use antacids, antacids and drugs to promote gastrointestinal motility; (5) Allergic to the test drug and its components; (6) Participate in other clinical studies within 12 weeks before screening; (7) The researcher believes that it is not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Comprehensive effective rate of dyspepsia symptoms;

Secondary

MeasureTime frame
Comprehensive effective rate of dyspepsia symptoms;Single symptom score of dyspepsia;Disappearance rate of single symptom of dyspepsia;weight;Head circumference;length;Recurrence rate of symptoms after body length withdrawal;

Countries

China

Contacts

Public ContactSitang Gong

Guangzhou Women and children's Medical Center

sitangg@126.com+86 139 2600 2111

Outcome results

None listed

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