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

NCT06985524 | Enrolling By Invitation

• 1 other identifier: 20240108120356554
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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).

Conditions

Functional Dyspepsia(FD) Was Studied

Outcome Measures

Primary Outcomes (1)

• TCM syndrome scores

  From enrollment to the end of treatment at 2 weeks

Study Arms (2)

Arm Weipi Formula

EXPERIMENTAL

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

Drug: Weipi Formula（Wu SiSi Formula）

Arm placebo

EXPERIMENTAL

Other: Placebo

Interventions

Weipi Formula（Wu SiSi Formula） DRUG

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

Arm Weipi Formula

Placebo OTHER

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

Arm placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

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

Nanchang, Jiangxi, 330006, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)