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

NCT06696261 | Recruiting Phase 3

• 1 other identifier: TSL-TCM-LXXPKL-Ⅲ
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 18

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

Conditions

Postprandial Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• postprandial distress syndrome score change from baseline

  The end of Week 8

• single symptom response rate

  The end of Week 8

• the change value of single symptom score from baseline

  The end of Week 8

• the change from baseline in epigstric pain syndrome score

  The end of Week 8

• epigastric pain syndrome response rate

  The end of Week 8

Study Arms (2)

Lianxiaxiaopi Granules

EXPERIMENTAL

Drug: Lianxiaxiaopi Granules

a simulated agent of Lianxiaxiaopi Granules

PLACEBO COMPARATOR

Drug: a simulated agent of Lianxiaxiaopi Granules

Interventions

Lianxiaxiaopi Granules DRUG

The participants took orally 1 sachet of Lianxiaxiaopi Granules, 3 times a day for 8 weeks.

Lianxiaxiaopi Granules

a simulated agent of Lianxiaxiaopi Granules DRUG

The participants took orally 1 sachet of simulated agent of Lianxiaxiaopi Granules, 3 times a day for 8 weeks.

a simulated agent of Lianxiaxiaopi Granules

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (18)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Gansu Provincial Hospital of Traditional Chinese Medicine

Lanzhou, Gansu, China

NOT YET RECRUITING

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Guiyang, Guizhou, China

NOT YET RECRUITING

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xingtai Medical College

Xingtai, Hebei, China

NOT YET RECRUITING

Baoding No. 1 Hospital of Traditional Chinese Medicine

Baoding, Heibei, China

NOT YET RECRUITING

The First People's Hospital of Luoyang City

Luoyang, Henan, China

RECRUITING

The Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, Jilin, China

NOT YET RECRUITING

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

Shenyang, Liaoning, China

NOT YET RECRUITING

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

NOT YET RECRUITING

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

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Xianyang, Shanxi, China

NOT YET RECRUITING

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

NOT YET RECRUITING

Zhejiang Provincial Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Wenzhou Hospital of Traditional Chinese Medicine

Wenzhou, Zhejiang, China

NOT YET RECRUITING

Central Study Contacts

Peimin Feng, Doctor

CONTACT

18981885791; 76262251@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 20, 2024
• Study Start: February 27, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (18)