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Real-World Study on the Efficacy and Safety of Xiangshao Granules Combined with Conventional Western Medicine in the Treatment of Functional Dyspepsia with Anxiety and Depression Symptoms

Real-World Study on the Efficacy and Safety of Xiangshao Granules Combined with Conventional Western Medicine in the Treatment of Functional Dyspepsia with Anxiety and Depression Symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119444
Enrollment
Unknown
Registered
2026-02-27
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

functional dyspepsia

Interventions

Conventional Western Medicine Monotherapy Group:NA
Xiangshao Granules Combined with Conventional Western Medicine Group:NA

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria for functional dyspepsia; 2. Score >= 10 on the Generalized Anxiety Disorder Scale (GAD-7) or score >= 10 on the Patient Health Questionnaire-9 (PHQ-9); 3. Female, aged 18–75 years; 4. Voluntarily signing the informed consent form and being able to cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Reflux esophagitis (LA Grade B or above), active peptic ulcer, positive Helicobacter pylori test results, malignant tumors of the digestive tract, and other organic diseases that may cause dyspeptic symptoms; 2. Patients with severe diseases of the cardiovascular, hepatic, pulmonary, renal, or hematological systems, or malignant tumors; Mental illnesses: schizophrenia, bipolar affective disorder, etc. 3. Mental illnesses: schizophrenia, bipolar affective disorder, etc. 4. Pregnant or lactating women; 5. Patients allergic to the components of Xiangshao Granules (Cyperi Rhizoma, Paeoniae Radix Alba, etc.); 6. Patients who have participated in other clinical trials within the past 3 months; 7. Other circumstances deemed unsuitable for enrollment by the researcher;

Design outcomes

Primary

MeasureTime frame
Reduction rate of the main symptom score of functional dyspepsia;Scores of Scales Including GAD-7, PHQ-9, and PHQ-15;Incidence Rate of Adverse Events;

Secondary

MeasureTime frame
Score of the Functional Gastrointestinal Disorder Quality of Life Scale (FDDQL);Evaluation of therapeutic efficacy for other symptoms of functional dyspepsia;

Countries

China

Contacts

Public ContactSujuan Fei

The Affiliated Hospital of Xuzhou Medical University

xyfyfeisj99@163.com+86 516 85802188

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026