To Observe the Clinical Efficacy of Traditional Chinese Medicine Compound(Weipi Formula ) in the Treatment of Epigastric Stuffiness Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Weipi Formula（Wu SiSi Formula）, Placebo.
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia(FD) Was Studied. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical and Preparation Studies of Traditional Chinese Medicine Compound(Weipi Formula) in the Treatment of Epigastric Stuffiness Syndrome
Overview
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
- Drug Weipi Formula（Wu SiSi Formula）
take Weipi Formula（Wu SiSi Formula） or the placebo daily for 2 weeks. - Other Placebo
Take Weipi Formula（Wu SiSi Formula） or the placebo daily for 2 weeks.
Primary outcome measures
- TCM syndrome scores [Time frame: From enrollment to the end of treatment at 2 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- he Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Donghu District, N — Nanchang
Identifiers
NCT: NCT06985524 · 20240108120356554