Efficacy and Safety of LiWei Capsule in Chronic Non-Atrophic Gastritis with Erosions
Study Overview
This study evaluated the effectiveness and safety of LiWei Capsule (LWC) for treating chronic non-atrophic gastritis (CNG) with erosions and damp-heat stasis syndrome. It followed the principles of Traditional Chinese Medicine (TCM).
Trial Details
The trial was a phase II, multicenter, randomized, double-blind study involving patients diagnosed with CNG. Participants were divided into three groups: LWC, Sanjiu Weitai Capsule (SJWT, a positive control), and a placebo. Each group received treatment for 4 weeks, followed by a 16-week follow-up.
Results
The main outcome measured was the reduction of epigastric pain and bloating. Secondary outcomes included improvements in endoscopic and histopathological examinations, along with TCM symptom scores. Out of 301 participants, 189 completed the study:
- Curative rates of epigastric pain/bloating: 76.84% (LWC), 42.22% (SJWT), 22.45% (placebo) – P < 0.001
- Healing rates of endoscopic erosions: 65.3% (LWC), 46.7% (SJWT), 30.6% (placebo) – P < 0.001
LWC showed significant effectiveness and safety in alleviating symptoms and promoting healing in patients with CNG.
Conclusion
LWC is a promising treatment option for chronic non-atrophic gastritis with erosions. This trial is registered under ChiCTR2100052010.
Value of Clinical Trials
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