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

Nanchang University

Status

Invitation-only

Conditions

Functional Dyspepsia(FD) Was Studied

Treatments

Drug: Weipi Formula（Wu SiSi Formula）

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06985524

20240108120356554

Details and patient eligibility

About

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).

Enrollment

256 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.