Lianxiaxiaopi Granules to treat 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).

This trial will test whether Lianxiaxiaopi Granules can help adults with postprandial distress syndrome reduce post-meal fullness, early satiety, or discomfort.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tasly Pharmaceutical Group Co., Ltd (Industry-sponsored)
• Locations: 18 sites (Beijing, Beijing Municipality and 17 other locations)
• Trial ID: NCT06696261 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter study in China compares Lianxiaxiaopi Granules with a matching simulated agent (placebo) in adults diagnosed with postprandial distress syndrome. Participants meet Rome IV criteria, have symptom intensity thresholds on numeric rating scales, negative H. pylori breath tests, and TCM syndrome differentiation consistent with the protocol. The main outcomes are the response rate for postprandial distress symptoms, change in individual symptom scores, and safety/tolerability monitoring. Sites include tertiary and provincial traditional Chinese medicine hospitals in Beijing, Gansu, and Guizhou.

Who should consider this trial

Good fit: Adults aged 18–65 with Rome IV–defined postprandial distress syndrome, NRS symptom scores ≥4 during screening and baseline, negative 13C/14C H. pylori test, and meeting the trial's TCM syndrome differentiation are ideal candidates.

Not a fit: People with organic gastrointestinal abnormalities on gastroscopy, positive H. pylori tests, predominant moderate/severe epigastric pain syndrome, or those outside the 18–65 age range are unlikely to benefit from this study treatment.

Why it matters

Potential benefit: If successful, the treatment could reduce post-meal fullness and early satiety and improve daily comfort and quality of life for people with postprandial distress syndrome.

How similar studies have performed: Some small studies of similar Chinese herbal formulas for functional dyspepsia have reported promising symptom improvements, but robust Phase 3 evidence specifically for Lianxiaxiaopi Granules is limited.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 17 other locations

• 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)

Study contacts

• Study coordinator: Peimin Feng, Doctor

Conditions Postprandial Distress Syndrome