he Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Donghu District, Nanchang City, Jiangxi Province, China
Nanchang, Jiangxi, 330006, China
Enrolling by Invitation
NCT Number: NCT06985524
To Observe the Clinical Efficacy of Traditional Chinese Medicine Compound(Weipi Formula ) in the Treatment of Epigastric Stuffiness Syndrome
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).
Enrolling by Invitation
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Weipi Formula（Wu SiSi Formula）
Drugtake Weipi Formula（Wu SiSi Formula） or the placebo daily for 2 weeks.
Placebo
OtherTake Weipi Formula（Wu SiSi Formula） or the placebo daily for 2 weeks.
Primary outcomes
-
TCM syndrome scores
Time frame: From enrollment to the end of treatment at 2 weeks
Sponsors and collaborators
Lead sponsor
Second Affiliated Hospital of Nanchang University
Other
Registry information
Official study title
Clinical and Preparation Studies of Traditional Chinese Medicine Compound(Weipi Formula) in the Treatment of Epigastric Stuffiness Syndrome
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 22, 2025
- Registry last updated
- May 22, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.