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

NCT06985524 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital of Nanchang University

Phase

Not applicable

Started

2024-01-01

Last updated

2025-05-22

Condition(s) studied

Functional Dyspepsia(FD) Was Studied

Investigational drug(s) / intervention(s)

Weipi Formula（Wu SiSi Formula）Placebo

Weipi Formula（Wu SiSi Formula）: take Weipi Formula（Wu SiSi Formula） or the placebo daily for 2 weeks.

Placebo: Take Weipi Formula（Wu SiSi Formula） or the placebo daily for 2 weeks.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

TCM syndrome scores — From enrollment to the end of treatment at 2 weeks

Trial sites (1)

Facility	City	Region	Status
he Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Donghu District, Nanchang City, Jiangxi Province, China	Nanchang	Jiangxi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06985524 on ClinicalTrials.gov ↗ ← All trials in China