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

NCT ID: NCT06985524

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-12-31

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).

Conditions

Functional Dyspepsia(FD) Was Studied

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm Weipi Formula

Participants will take Weipi Formula（Wu SiSi Formula）for 2 weeks.

Group Type: EXPERIMENTAL

Weipi Formula（Wu SiSi Formula）

Intervention Type: DRUG

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

Arm placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: OTHER

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

Interventions

Weipi Formula（Wu SiSi Formula）

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

20240108120356554

Identifier Type: -

Identifier Source: org_study_id