To Observe the Clinical Efficacy of Traditional Chinese Medicine Compound(Weipi Formula ) in the Treatment of Epigastric Stuffiness Syndrome

Not Applicable

• Conditions: Functional Dyspepsia(FD) Was Studied
• Interventions: Drug: Weipi Formula（Wu SiSi Formula）; Other: Placebo

• Registration Number: NCT06985524
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

Brief Summary

The purpose of this clinical trial is to evaluate the efficacy of the herbal drug Weipi formula in treating functional dyspepsia (FD) in adults. It will also assess the safety of Weipi formula. The main questions the study aims to answer are:

Does Weipi formula reduce participants' TCM syndrome scores? What medical issues might participants experience while taking Weipi formula?

Researchers will compare Weipi formula with a placebo (an identical-looking substance without active drugs) to determine whether Weipi formula is effective in treating functional dyspepsia.

Participant Procedures

Participants will:

Take Weipi formula or the placebo daily for 2 weeks.

Visit the clinic once every week for examinations and tests. Record their symptoms and undergo measurements (e.g., pepsin levels).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• ① Meet the diagnostic criteria for epigastric fullness (Pi-Man) in Traditional Chinese Medicine (TCM);

  • Meet the Western diagnostic criteria for functional dyspepsia (FD), specifically postprandial distress syndrome (PDS) subtype, or meet both PDS and epigastric pain syndrome (EPS) subtypes but with PDS as the dominant presentation;

    • Age 18-80 years;

      • Willing to sign the informed consent form.

Exclusion Criteria

• ① Gastroscopy findings: Benign or malignant digestive diseases (e.g., peptic ulcer, gastric cancer);

  • Severe organic diseases of the liver, gallbladder, spleen, or pancreas;

    • Severe organic diseases in other organ systems;

      • Pregnant or lactating women; ⑤ Patients with psychiatric disorders causing similar symptoms (e.g., schizophrenia, anxiety disorder, major depressive disorder); ⑥ Regular use (≥3 months) of NSAIDs and/or selective COX-2 inhibitors; ⑦ Potassium supplements taken within 2 weeks prior to enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm Weipi Formula	Weipi Formula（Wu SiSi Formula）	Participants will take Weipi Formula（Wu SiSi Formula）for 2 weeks.
Arm placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
TCM syndrome scores	From enrollment to the end of treatment at 2 weeks

Trial Locations

Locations (1)

he Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Donghu District, Nanchang City, Jiangxi Province, China; 🇨🇳 Nanchang, Jiangxi, China