A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome

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:

1. Based on the Response rate of postprandial distress syndrome participants, evaluate whether the efficacy of Lianxiaxiaopi Granules is superior to placebo.
2. Evaluate the efficacy of Lianxiaxiaopi Granules in improving symptom of postprandial distress syndrome.
3. Evaluating the safety of Lianxiaxiaopi Granules in postprandial distress syndrome participants.

Study Overview

• Status: Recruiting
• Conditions: Postprandial Distress Syndrome
• Intervention / Treatment: Drug: Lianxiaxiaopi Granules; Drug: a simulated agent of Lianxiaxiaopi Granules

• Study Type: Interventional
• Enrollment (Estimated): 342
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Peimin Feng, Doctor; Phone Number: 18981885791; Email: 76262251@qq.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Not yet recruiting
      • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
      • Contact: Yuning Bai; Phone Number: 13366266838
  • Gansu
    • Lanzhou, Gansu, China
      • Not yet recruiting
      • Gansu Provincial Hospital of Traditional Chinese Medicine
      • Contact: Xudong Tian; Phone Number: 15002591589
  • Guizhou
    • Guiyang, Guizhou, China
      • Not yet recruiting
      • The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
      • Contact: Sufang Zhou; Phone Number: 13639082908
  • Hebei
    • Shijiazhuang, Hebei, China
      • Not yet recruiting
      • Hebei Provincial Hospital of Traditional Chinese Medicine
      • Contact: Qian Yang; Phone Number: 13832355120
    • Xingtai, Hebei, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Xingtai Medical College
      • Contact: Shuangzhao Xu; Phone Number: 15612978266
  • Heibei
    • Baoding, Heibei, China
      • Not yet recruiting
      • Baoding No. 1 Hospital of Traditional Chinese Medicine
      • Contact: Jianhai Niu; Phone Number: 15731291866
  • Henan
    • Luoyang, Henan, China
      • Recruiting
      • The First People's Hospital of Luoyang City
      • Contact: Hongling Liu; Phone Number: 18538882095
  • Jilin
    • Changchun, Jilin, China
      • Not yet recruiting
      • The Affiliated Hospital of Changchun University of Traditional Chinese Medicine
      • Contact: Yan Leng; Phone Number: 15948000725
  • Liaoning
    • Shenyang, Liaoning, China
      • Not yet recruiting
      • General Hospital of the Northern Theater of the Chinese People's Liberation Army
      • Contact: Yang Gong; Phone Number: 13309888136
    • Shenyang, Liaoning, China
      • Not yet recruiting
      • The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
      • Contact: Yufeng Li; Phone Number: 18102456191
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Not yet recruiting
      • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
      • Contact: Shengquan Fang; Phone Number: 18930566355
  • Shanxi
    • Xianyang, Shanxi, China
      • Not yet recruiting
      • The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
      • Contact: Jiehong Wang; Phone Number: 15091063809
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
      • Contact: Peimin Feng; Phone Number: 18981885791
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital Sichuan University
      • Contact: Qing Xia; Phone Number: 18980601723
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Not yet recruiting
      • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
      • Contact: Zhenghua Zhou; Phone Number: 15202248272
  • Yunnan
    • Kunming, Yunnan, China
      • Not yet recruiting
      • The First Affiliated Hospital of Kunming Medical University
      • Contact: Ying Zhang; Phone Number: 13708450827
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Provincial Hospital of Traditional Chinese Medicine
      • Contact: Bin Lv; Phone Number: 13906515409
    • Wenzhou, Zhejiang, China
      • Not yet recruiting
      • Wenzhou Hospital of Traditional Chinese Medicine
      • Contact: Yaoming Zeng; Phone Number: 13867704929

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lianxiaxiaopi Granules	Drug: Lianxiaxiaopi Granules; The participants took orally 1 sachet of Lianxiaxiaopi Granules, 3 times a day for 8 weeks.
Placebo Comparator: a simulated agent of Lianxiaxiaopi Granules	Drug: a simulated agent of Lianxiaxiaopi Granules; The participants took orally 1 sachet of simulated agent of Lianxiaxiaopi Granules, 3 times a day for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The end of Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
single symptom response rate		The end of Week 8
epigastric pain syndrome response rate		The end of Week 8
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.	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.	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	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.	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.	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%.	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.	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.	The end of Week 12

Collaborators and Investigators

• Sponsor: Tasly Pharmaceutical Group Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 17, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: TSL-TCM-LXXPKL-Ⅲ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No