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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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.;

Trial design

Treatments tested in this trial

  • Lianxiaxiaopi Granules
  • a simulated agent of Lianxiaxiaopi Granules

Treatment groups

342 Participants
are divided into 2 treatment groups