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Effectiveness and Safety of Biling Weitong Granules in the Treatment of Functional Dyspepsia:A real-world study

Effectiveness and Safety of Biling Weitong Granules in the Treatment of Functional Dyspepsia:A real-world study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072256
Enrollment
Unknown
Registered
2023-06-07
Start date
2023-06-12
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

functional dyspepsia

Interventions

Queue 1 (Biling Weitong Granules):None
Queue 2 (proton pump inhibitor):None
Queue 3 (Biling Weitong Granules+proton pump inhibitor):None

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria for functional dyspepsia EPS or have PDS with overlapping EPS; 2. Age range from 18 to 75 years old, regardless of gender; 3. Middle and upper abdominal pain or burning discomfort in the middle and upper abdomen shall be evaluated using a 5-level Likert scale score (0 points for asymptomatic symptoms, 4 points for obvious symptoms that seriously affect work and life), with an average score of = 2 points for any item in the past 1 week (calculation method of average score: the total score of the past 1 week duration divided by the number of days with symptoms); 4. Voluntarily sign an informed consent form to participate in this study.

Exclusion criteria

Exclusion criteria: 1.Reflux esophagitis (LA-B grade or above), active peptic ulcers, malignant tumors of the upper digestive tract, and other organic diseases that may cause discomfort or burning sensation in the upper middle abdomen; 2. Severe heart, brain, liver, lung, kidney, tumor and other diseases; 3. Those who have participated in other clinical research trials within the past 3 months; 4. Other factors that the researcher believes are not suitable for enrollment

Design outcomes

Primary

MeasureTime frame
Clinical efficacy rate;

Secondary

MeasureTime frame
Clinical effectiveness of each visit point;Frequency of discomfort caused by upper abdominal pain and burning;Rate/time of disappearance of upper abdominal pain and burning discomfort;Efficacy of other symptoms in FD;Functional Gastrointestinal Disease Quality of Life Scale Score;Traditional Chinese Medicine Syndrome Curative Effect;Consumption of Hydrotalcite Tablets;Satisfaction score of treatment efficacy;Incidence of adverse events/reactions;

Countries

China

Contacts

Public Contactfangxiucai

Peking Union Medical College Hospital

fangxiucai2@aliyun.com+86 134 3913 6086

Outcome results

None listed

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