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Lianxiaxiaopi Granules in postprandial distress syndrome
NCT06696261Phase 3
Key facts
- Status
- Recruiting
- Start
- Feb 2025
- Primary completion
- Dec 2026
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- Postprandial Distress Syndrome (PDS)
01
Overview
Phase 3, randomised, double-blind trial in Postprandial Distress Syndrome (PDS) comparing Lianxiaxiaopi Granules with Placebo (2 arms). Primary endpoint: Postprandial Distress Syndrome Response Rate at 8 weeks. Started Feb 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Lianxiaxiaopi Granules
Active treatment with Lianxiaxiaopi Granules
Placebo
Placebo comparator (simulated agent)
03
Who it enrols
Adults aged 18-65 with postprandial distress syndrome (Rome IV criteria) meeting TCM cold and heat miscellaneous syndrome criteria, with NRS score ≥4 for at least one PDS symptom, negative H. pylori test, normal or minimal gastroscopy findings, without organic digestive diseases, severe systemic diseases, or recent use of medications affecting gastrointestinal function
04
Endpoints
Primary
Postprandial Distress Syndrome Response Rate
Secondary
Postprandial Distress Syndrome Score Change from Baseline
Single Symptom Response Rate
Single Symptom Score Change from Baseline
Epigastric Pain Syndrome Score Change from Baseline
Epigastric Pain Syndrome Response Rate
Traditional Chinese Medicine Total Score Change from Baseline
Traditional Chinese Medicine Single Symptom Score Change from Baseline
Traditional Chinese Medicine Syndrome Integral Effective Rate
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