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

Clinical and Preparation Studies of Traditional Chinese Medicine Compound(Weipi Formula) in the Treatment of Epigastric Stuffiness Syndrome

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06985524
Enrollment
256
Registered
2025-05-22
Start date
2024-01-01
Completion date
2026-12-31
Last updated
2025-05-22

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

Conditions

Functional Dyspepsia(FD) Was Studied

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).

Interventions

DRUGWeipi Formula(Wu SiSi Formula)

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

OTHERPlacebo

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

Sponsors

Second Affiliated Hospital of Nanchang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
TCM syndrome scoresFrom enrollment to the end of treatment at 2 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026