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Herbal granules aim to ease Post-Meal stomach troubles

NCT ID NCT06696261

Symptom relief Sponsor: Tasly Pharmaceutical Group Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether Lianxiaxiaopi Granules, a traditional Chinese herbal medicine, can relieve symptoms of postprandial distress syndrome (stomach discomfort, fullness, or early fullness after meals). 342 adults aged 18-65 will take the granules or a placebo three times daily for 8 weeks. The study measures how many weeks symptoms improve by at least half compared to baseline.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lianxiaxiaopi Granules (herbal granules)
What this could lead to
If successful, this could provide a new herbal treatment option for people with postprandial distress syndrome, reducing discomfort after meals.
What could go wrong
This is a Phase 3 trial, but the intervention is based on Traditional Chinese Medicine concepts (cold/heat imbalance) which may not be accepted by all. The placebo response in digestive disorders can be high, so the real benefit may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 342 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 to 65 years old (including boundary value), gender is not limited; 2. meet the diagnostic criteria for postprandial distress syndrome (Rome IV.); 3. Meet the syndrome differentiation standards of Traditional Chinese Medicine for cold and heat miscellaneous syndromes; 4. NRS score of at least one symptom of postprandial distress syndrome (postprandial fullness, discomfort, early satiety) in the screening period and baseline period≥ 4 points; and did not have moderate/severe epigastric pain syndrome (mid-epigastric burning sensation and mid-upper quadrant pain both \< 4 points); 5. Those who did not have organic abnormal changes in the results of gastroscopy (including no abnormalities in gastroscopy, chronic non-atrophic gastritis/chronic superficial gastritis with erythema grade I and/or erosion that was flat and only grade I); 6. Negative Helicobacter pylori test in 13C/14C breath test during the screening period; 7. Voluntarily participate in clinical trials, sign informed consent, and understand and comply with research procedures. Exclusion Criteria: 1. Those who have undergone Helicobacter pylori eradication treatment within 6 months before screening; 2. Gastric mucosal erythema grade II or above, erosion is bulge or grade II or above, or accompanied by bleeding, bile reflux, ≥ 3 inflammatory polyps and other manifestations, or combined with pathological diagnosis of chronic atrophic gastritis, hyperplastic polyps, glandular polyps, etc.; or those who have been clearly diagnosed with dyspepsia caused by organic diseases of the digestive system, such as digestive tract tumors, hepatobiliary and pancreatic diseases, inflammatory bowel diseases, etc.; or those who have other diseases that affect the evaluation of dyspepsia-related symptoms in the past, such as reflux esophagitis, peptic ulcer, gastrointestinal bleeding, intestinal obstruction, etc.; 3. Those who have been diagnosed with systemic diseases that seriously affect the function of the digestive tract, such as hyperthyroidism or hypothyroidism, diabetes, chronic renal insufficiency, connective tissue diseases, etc.; 4. Patients with severe cardiovascular and cerebrovascular, liver, lung, kidney, blood or systemic diseases that affect their survival; or patients with severe mental illness in the past, such as moderate or severe depression/anxiety/bipolar disorder, etc.; 5. Those who have a history of major abdominal surgery in the past, which may affect gastrointestinal function (except for appendectomy, cesarean section, endoscopic colon polyp resection and other surgeries that do not affect digestive function); 6. Patients with abnormal liver function (ALT or AST \>1.5 times the upper limit of normal) or abnormal renal function test (Cr\> upper limit of normal); 7. Glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥7mmol/L during the screening period; 8. Use of drugs or treatments that may have an impact on the effectiveness assessment of the trial drug within 2 weeks before screening (such as acid/antacids, gastrointestinal motility drugs, digestive enzymes, gastric mucosal protectors, antiemetics, antispasmodics, macrolide antimicrobials, azole antifungals, non-steroidal anti-inflammatory drugs, glucocorticoids, anti-anxiety and depressants, analgesics, sedatives; as well as traditional Chinese medicine decoctions, proprietary Chinese medicines and acupuncture treatments for the treatment of functional dyspepsia, etc.); 9. Pregnant and lactating women, who have a birth plan within one month after enrollment and the end of the trial; 10. Those who suspect or have a history of alcohol or drug abuse; 11. Participated in other clinical trials within 1 month before screening; 12. Those who are suspected or known to be allergic to the ingredients of this medicine; 13. According to the judgment of the investigator, it is not suitable to participate in this study.

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Conditions

The condition(s) this trial relates to.

dyspepsia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postprandial distress syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baoding No. 1 Hospital of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Baoding, Heibei, China

  • Gansu Provincial Hospital of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Lanzhou, Gansu, China

  • General Hospital of the Northern Theater of the Chinese People's Liberation Army

    NOT_YET_RECRUITING

    Shenyang, Liaoning, China

  • Guang'anmen Hospital, China Academy of Chinese Medical Sciences

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Hebei Provincial Hospital of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • The Affiliated Hospital of Changchun University of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Changchun, Jilin, China

  • The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    RECRUITING

    Chengdu, Sichuan, China

  • The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Shenyang, Liaoning, China

  • The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Xianyang, Shanxi, China

  • The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Guiyang, Guizhou, China

  • The First Affiliated Hospital of Kunming Medical University

    NOT_YET_RECRUITING

    Kunming, Yunnan, China

  • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, China

  • The First People's Hospital of Luoyang City

    RECRUITING

    Luoyang, Henan, China

  • The Second Affiliated Hospital of Xingtai Medical College

    NOT_YET_RECRUITING

    Xingtai, Hebei, China

  • Wenzhou Hospital of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Wenzhou, Zhejiang, China

  • West China Hospital Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

  • Zhejiang Provincial Hospital of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

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