ClinicalTrials.gg
Enrolling by invitationNCT06985524Updated May 22, 2025

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

An interventional study of Weipi Formula(Wu SiSi Formula) and Placebo in Functional Dyspepsia(FD) Was Studied, sponsored by Second Affiliated Hospital of Nanchang University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Second Affiliated Hospital of Nanchang University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jan 2024, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Functional Dyspepsia(FD) Was Studied

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03

In context

Dyspepsia

372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.

This study's planned enrollment of 256 is above the median of 89 across 302 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Second Affiliated Hospital of Nanchang University is the lead sponsor of 85 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
256 participants (estimated)

Study arms

  • Experimental
    Arm Weipi Formula

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

    Drug: Weipi Formula(Wu SiSi Formula)

  • Experimental
    Arm placebo

    Other: Placebo

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.

06

What researchers measure

Primary outcomes

  1. TCM syndrome scores

    Time frame: From enrollment to the end of treatment at 2 weeks

07

Study locations

1 site
  • he Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Donghu District, Nanchang City, Jiangxi Province, China
    Nanchang, Jiangxi 330006, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06985524
Lead sponsor
Second Affiliated Hospital of Nanchang University
Responsible party
Sponsor
First posted
May 22, 2025
Start date
Jan 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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