Postprandial Distress SyndromePhase 3NCT06696261
A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome
A Phase 3 study testing Lianxiaxiaopi Granules and a simulated agent of Lianxiaxiaopi Granules in people with Postprandial Distress Syndrome, run by Tasly Pharmaceutical Group Co., Ltd at 18 sites in China.
Trial summary
The goal of this clinical trial is evaluating the efficacy and safety of Lianxiaxiaopi Granules in participant population. The main questions it aims to answer are: 1. Based on the Response rate of postprandial distress syndrome participants, evaluate whether the efficacy of Lianxiaxiaopi Granules is superior to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postprandial Distress Syndrome
- What is being tested?
- Lianxiaxiaopi Granules and a simulated agent of Lianxiaxiaopi Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 18 sitesChina
- Study dates
- 27 Feb 2025to 31 Dec 2026
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years old (including boundary value), gender is not limited;
- meet the diagnostic criteria for postprandial distress syndrome (Rome IV.);
- Meet the syndrome differentiation standards of Traditional Chinese Medicine for cold and heat miscellaneous syndromes;
- 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);
- 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);
- Negative Helicobacter pylori test in 13C/14C breath test during the screening period;
- Voluntarily participate in clinical trials, sign informed consent, and understand and comply with research procedures.
Who cannot join
- Those who have undergone Helicobacter pylori eradication treatment within 6 months before screening;
- 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.;
- 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.;
- 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.;
- 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);
- 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);
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- Glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥7mmol/L during the screening period;
- 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.);
- Pregnant and lactating women, who have a birth plan within one month after enrollment and the end of the trial;
- Those who suspect or have a history of alcohol or drug abuse;
- Participated in other clinical trials within 1 month before screening;
- Those who are suspected or known to be allergic to the ingredients of this medicine;
- According to the judgment of the investigator, it is not suitable to participate in this study.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites, 18 recruiting
- Not yet recruiting
Baoding No. 1 Hospital of Traditional Chinese Medicine
Baoding, Heibei
Jianhai Niu, 15731291866
- Not yet recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality
Yuning Bai, 13366266838
- Not yet recruiting
The Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin
Yan Leng, 15948000725
- Recruiting
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan
Peimin Feng, 18981885791
- Not yet recruiting
West China Hospital Sichuan University
Chengdu, Sichuan
Qing Xia, 18980601723
- Not yet recruiting
The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Guiyang, Guizhou
Sufang Zhou, 13639082908
- Not yet recruiting
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang
Bin Lv, 13906515409
- Not yet recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Ying Zhang, 13708450827
- Not yet recruiting
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu
Xudong Tian, 15002591589
- Recruiting
The First People's Hospital of Luoyang City
Luoyang, Henan
Hongling Liu, 18538882095
- Not yet recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Shengquan Fang, 18930566355
- Not yet recruiting
General Hospital of the Northern Theater of the Chinese People's Liberation Army
Shenyang, Liaoning
Yang Gong, 13309888136
- Not yet recruiting
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning
Yufeng Li, 18102456191
- Not yet recruiting
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei
Qian Yang, 13832355120
- Not yet recruiting
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
Zhenghua Zhou, 15202248272
- Not yet recruiting
Wenzhou Hospital of Traditional Chinese Medicine
Wenzhou, Zhejiang
Yaoming Zeng, 13867704929
- Not yet recruiting
The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
Xianyang, Shanxi
Jiehong Wang, 15091063809
- Not yet recruiting
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei
Shuangzhao Xu, 15612978266
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo Parallel-controlled Phase III Clinical Trial on the Efficacy and Safety of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome (Intermingled Cold and Heat).
The goal of this clinical trial is evaluating the efficacy and safety of Lianxiaxiaopi Granules in participant population. The main questions it aims to answer are:
- Based on the Response rate of postprandial distress syndrome participants, evaluate whether the efficacy of Lianxiaxiaopi Granules is superior to placebo.
- Evaluate the efficacy of Lianxiaxiaopi Granules in improving symptom of postprandial distress syndrome.
- Evaluating the safety of Lianxiaxiaopi Granules in postprandial distress syndrome participants.
- Conditions
- Postprandial Distress Syndrome
- Being tested
- Lianxiaxiaopi Granules, a simulated agent of Lianxiaxiaopi Granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lianxiaxiaopi GranulesDrug
The participants took orally 1 sachet of Lianxiaxiaopi Granules, 3 times a day for 8 weeks.
a simulated agent of Lianxiaxiaopi GranulesDrug
The participants took orally 1 sachet of simulated agent of Lianxiaxiaopi Granules, 3 times a day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lianxiaxiaopi Granules | Experimental | Not described Receives: Drug: Lianxiaxiaopi Granules |
| a simulated agent of Lianxiaxiaopi Granules | Placebo comparator | Not described Receives: Drug: a simulated agent of Lianxiaxiaopi Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial distress syndrome response rate
Postprandial Distress Syndrome Response, the number of weeks in which the subject responded to the postprandial distress syndrome was greater than 50% of the weeks throughout the treatment period.
Response week, if the two symptoms of postprandial fullness and discomfort and early satiety decreased by ≥50% compared with the baseline per week, the response week was calculated by the diary card score.
Measured: The end of Week 8
Secondary outcomes (10)
postprandial distress syndrome score change from baseline
"The dyspepsia symptom scoring criteria" consists of 5 items, with a minimum score of 0 and a maximum of 10 points for each item.
0 points: asymptomatic; 1-3 points: mild disturbance, mild symptoms, almost no impact on daily life and work; 4-6 points: moderate disturbance, still tolerable, partially affecting daily life and work; 7-10 points: Severe disturbance, unbearable, unable to carry out daily life and work.
The minimum score of the scale is 0 points, the maximum is 50 points, and the higher the score, the more serious the disease.
Measured: The end of Week 8
single symptom response rate
Measured: The end of Week 8
the change value of single symptom score from baseline
"The dyspepsia symptom scoring criteria" consists of 5 items, with a minimum score of 0 and a maximum of 10 points for each item.
0 points: asymptomatic; 1-3 points: mild disturbance, mild symptoms, almost no impact on daily life and work; 4-6 points: moderate disturbance, still tolerable, partially affecting daily life and work; 7-10 points: Severe disturbance, unbearable, unable to carry out daily life and work.
Measured: The end of Week 8
the change from baseline in epigstric pain syndrome score
"The dyspepsia symptom scoring criteria" consists of 5 items, with a minimum score of 0 and a maximum of 10 points for each item.
0 points: asymptomatic; 1-3 points: mild disturbance, mild symptoms, almost no impact on daily life and work; 4-6 points: moderate disturbance, still tolerable, partially affecting daily life and work; 7-10 points: Severe disturbance, unbearable, unable to carry out daily life and work.
The score for epigastric pain syndrome includes the sum of the scores for mid-upper quadrant pain and mid-upper quadrant burning sensation
Measured: The end of Week 8
epigastric pain syndrome response rate
Measured: The end of Week 8
the change from baseline in the total score of TCM
The TCM Syndrome Scale for Postprandial Distress Syndrome contains two main symptoms, each of which can be evaluated as 0, 2, 4 and 6 points. 6 sub-symptoms, each of which can be evaluated as 0, 1, 2, and 3 points.
The scale has a minimum score of 0 and a maximum of 30 points, with the higher the score, the more severe the condition.
Measured: The end of Week 8
the change value of TCM single symptom score from baseline
The TCM Syndrome Scale for Postprandial Distress Syndrome contains two main symptoms, each of which can be evaluated as 0, 2, 4 and 6 points. 6 sub-symptoms, each of which can be evaluated as 0, 1, 2, and 3 points.
The scale has a minimum score of 0 and a maximum of 30 points, with the higher the score, the more severe the condition.
Measured: The end of Week 8
TCM syndrome integral effective rate
Recovery: Symptoms and signs disappear or basically disappear, and the score reduction rate of the syndrome ≥95%; Effective: Symptoms and signs improved, and the score reduction rate of the syndrome was ≥50%; Ineffective: no significant improvement in symptoms and signs, and the score reduction rate of the syndrome <50%.
Recovery: Symptoms and signs disappear or basically disappear, and the score reduction rate of the syndrome ≥95%; Effective: Symptoms and signs improved, and the score reduction rate of the syndrome was ≥50%; Ineffective: no significant improvement in symptoms and signs, and the score reduction rate of the syndrome <50%.
Recovery: Symptoms and signs disappear or basically disappear, and the score reduction rate of the syndrome ≥95%; Effective: Symptoms and signs improved, and the score reduction rate of the syndrome was ≥50%; Ineffective: no significant improvement in symptoms and signs, and the score reduction rate of the syndrome <50%.
Measured: The end of Week 8
the grade change of TCM single symptom from baseline
The TCM Syndrome Scale for Postprandial Distress Syndrome contains two main symptoms, each of which can be evaluated as 0, 2, 4 and 6 points. 6 sub-symptoms, each of which can be evaluated as 0, 1, 2, and 3 points.
The scale has a minimum score of 0 and a maximum of 30 points, with the higher the score, the more severe the condition.
Measured: The end of Week 8
the proportion of subjects with sustained remission and no exacerbation of single symptoms at 12W compared with 8W
There are 5 items in the Likert scale, with a minimum score of 1 and a maximum of 7 points for each item. The scale has a minimum score of 0 and a maximum of 35 points, with higher scores and more severe conditions.
Among them, the subjects selected (1) and (2) are defined as having sustained remission from treatment; Subjects selected (3) and (4) were defined as having no exacerbation of disease; Subjects selected (5), (6), and (7) were defined as having exacerbated disease.
Measured: The end of Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start27 Feb 2025
- 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 Postprandial Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696261
- Sponsor's protocol ID
- TSL-TCM-LXXPKL-Ⅲ
- Status last verified
- Jan 2026
- First submitted
- 8 Nov 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo Parallel-controlled Phase III Clinical Trial on the Efficacy and Safety of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome (Intermingled Cold and Heat).
- ClinicalTrials.gov ID
- NCT06696261
- Acronym / sponsor ID
- TSL-TCM-LXXPKL-Ⅲ
- Conditions
- Postprandial Distress Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 2024 (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 goal of this clinical trial is evaluating the efficacy and safety of Lianxiaxiaopi Granules in participant population. The main questions it aims to answer are:
- Based on the Response rate of postprandial distress syndrome participants, evaluate whether the efficacy of Lianxiaxiaopi Granules is superior to placebo.
- Evaluate the efficacy of Lianxiaxiaopi Granules in improving symptom of postprandial distress syndrome.
- Evaluating the safety of Lianxiaxiaopi Granules in postprandial distress syndrome participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lianxiaxiaopi Granules | Experimental | Drug: Lianxiaxiaopi Granules |
| a simulated agent of Lianxiaxiaopi Granules | Placebo comparator | Drug: a simulated agent of Lianxiaxiaopi Granules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 65 years old (including boundary value), gender is not limited;
- meet the diagnostic criteria for postprandial distress syndrome (Rome IV.);
- Meet the syndrome differentiation standards of Traditional Chinese Medicine for cold and heat miscellaneous syndromes;
- 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);
- 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);
Key exclusion criteria (13 listed)
- Those who have undergone Helicobacter pylori eradication treatment within 6 months before screening;
- 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.;
- 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.;
- 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.;
- 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);
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 |
|---|---|---|
| Lianxiaxiaopi GranulesThe participants took orally 1 sachet of Lianxiaxiaopi Granules, 3 times a day for 8 weeks. | Drug | Lianxiaxiaopi Granules |
| a simulated agent of Lianxiaxiaopi GranulesThe participants took orally 1 sachet of simulated agent of Lianxiaxiaopi Granules, 3 times a day for 8 weeks. | Drug | a simulated agent of Lianxiaxiaopi Granules |
Primary outcome
Postprandial distress syndrome response rate
Time frame: The end of Week 8
Postprandial Distress Syndrome Response, the number of weeks in which the subject responded to the postprandial distress syndrome was greater than 50% of the weeks throughout the treatment period. Response week, if the two symptoms of postprandial fullness and discomfort and early satiety decreased by ≥50% compared with the baseline per week, the response week was calculated by the diary card score.
10 secondary outcomes
postprandial distress syndrome score change from baseline
Time frame: The end of Week 8
single symptom response rate
Time frame: The end of Week 8
the change value of single symptom score from baseline
Time frame: The end of Week 8
the change from baseline in epigstric pain syndrome score
Time frame: The end of Week 8
epigastric pain syndrome response rate
Time frame: The end of Week 8
the change from baseline in the total score of TCM
Time frame: The end of Week 8
the change value of TCM single symptom score from baseline
Time frame: The end of Week 8
TCM syndrome integral effective rate
Time frame: The end of Week 8
the grade change of TCM single symptom from baseline
Time frame: The end of Week 8
the proportion of subjects with sustained remission and no exacerbation of single symptoms at 12W compared with 8W
Time frame: The end of Week 12
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 20 Jan 2026.
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lianxiaxiaopi Granules and a simulated agent of Lianxiaxiaopi Granules in people with Postprandial Distress Syndrome, run by Tasly Pharmaceutical Group Co., Ltd at 18 sites 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Peimin Feng, Doctor (18981885791, 76262251@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial distress syndrome response rate (time frame: The end of Week 8). 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 20 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.