Functional Dyspepsia(FD) Was StudiedNCT06985524
To Observe the Clinical Efficacy of Traditional Chinese Medicine Compound(Weipi Formula ) in the Treatment of Epigastric Stuffiness Syndrome
A study testing Weipi Formula（Wu SiSi Formula） in people with Functional Dyspepsia(FD) Was Studied, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Dyspepsia(FD) Was Studied
- What is being tested?
- Weipi Formula（Wu SiSi Formula）
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
he Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Donghu District, Nanchang City, Jiangxi Province, China
Nanchang, Jiangxi, 330006
About this study
Official title: Clinical and Preparation Studies 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?
Read more
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
- Being tested
- Weipi Formula（Wu SiSi Formula）, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weipi Formula（Wu SiSi Formula）Drug
take Weipi Formula（Wu SiSi Formula） or the placebo daily for 2 weeks.
PlaceboOther
Take Weipi Formula（Wu SiSi Formula） or the placebo daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm Weipi Formula | Experimental | Participants will take Weipi Formula（Wu SiSi Formula）for 2 weeks. Receives: Drug: Weipi Formula（Wu SiSi Formula） |
| Arm placebo | Experimental | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TCM syndrome scores
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Dyspepsia(FD) Was StudiedStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985524
- Sponsor's protocol ID
- 20240108120356554
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Preparation Studies of Traditional Chinese Medicine Compound(Weipi Formula) in the Treatment of Epigastric Stuffiness Syndrome
- ClinicalTrials.gov ID
- NCT06985524
- Acronym / sponsor ID
- 20240108120356554
- Conditions
- Functional Dyspepsia(FD) Was Studied
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Weipi Formula | Experimental | Drug: Weipi Formula（Wu SiSi Formula）Participants will take Weipi Formula（Wu SiSi Formula）for 2 weeks. |
| Arm placebo | Experimental | Other: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ① Meet the diagnostic criteria for epigastric fullness (Pi-Man) in Traditional Chinese Medicine (TCM);
Key exclusion criteria (4 listed)
- ① Gastroscopy findings: Benign or malignant digestive diseases (e.g., peptic ulcer, gastric cancer);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weipi Formula（Wu SiSi Formula）take Weipi Formula（Wu SiSi Formula） or the placebo daily for 2 weeks. | Drug | Arm Weipi Formula |
| PlaceboTake Weipi Formula（Wu SiSi Formula） or the placebo daily for 2 weeks. | Other | Arm placebo |
Primary outcome
TCM syndrome scores
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weipi Formula（Wu SiSi Formula） in people with Functional Dyspepsia(FD) Was Studied, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCM syndrome scores (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.