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YQD Combined With Plant Lactobacillus for Slow Transit Constipation
Sponsor: First People's Hospital Of Lin'an District, Hangzhou
Summary
Slow transit constipation (STC) is a common and difficult-to-treat subtype of chronic constipation, characterized by reduced colonic motility and delayed stool passage. Current treatments often provide limited long-term relief, and many patients relapse after stopping medication. This study aims to evaluate whether combining a traditional Chinese herbal formula (Yìqì Jiànpí Decoction, YQD) with plant-derived Lactobacillus probiotics provides better and more sustained relief than either treatment alone or standard prokinetic therapy. A total of 120 eligible patients with STC will be randomly assigned to four groups in a 1:1:1:1 ratio: (1) YQD + Lactobacillus + mosapride; (2) YQD + mosapride; (3) Lactobacillus + mosapride; (4) mosapride alone. The treatment lasts 8 weeks. The primary outcome is the change in Constipation Severity Score from baseline to week 8. Secondary outcomes include quality of life, colonic transit time, gut microbiota changes, and relapse rate during a 6-month follow-up period. This study will provide evidence on whether an integrative TCM-probiotic strategy offers superior and more durable benefits for STC patients.
Official title: Efficacy of Yìqì Jiànpí Decoction Combined With Plant Lactobacillus in Treating Slow Transit Constipation: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-01-01
Completion Date
2026-08-01
Last Updated
2026-08-11
Healthy Volunteers
No
Conditions
Interventions
YQD (Yìqì Jiànpí Decoction)
A 12-herb traditional Chinese medicine formula consisting of Cistanche deserticola (Roucongrong) 15 g, Atractylodes macrocephala (Baizhu) 15 g, Astragalus membranaceus (Huangqi) 20 g, Cynanchum wilfordii (Geshangiao) 15 g, Scrophularia ningpoensis (Xuanshen) 12 g, Raphanus sativus (Laifuzi) 15 g, Dioscorea opposita (Shanyao) 12 g, Galli Gigerii Endothelium Corneum (Jineijin) 15 g, Sesamum indicum (Heizhima) powder 12 g, Cyathula officinalis (Chuanniuxi) 15 g, Massa Medicata Fermentata (Shenqu) 15 g, and Colla Corii Asini (Ejiao) 12 g. One dose is immersed in 1000 mL distilled water for 30 min, boiled, then simmered for 30 min, filtered; the residue is re-boiled with another 1000 mL, combined, and concentrated to 100 mL. Patients take the entire 100 mL once daily in the morning for 8 weeks.
Plant-derived Lactobacillus
Commercially available compound Lactobacillus tablets containing ≥10⁹ CFU of plant-derived Lactobacillus strains per tablet. Patients take 3 tablets twice daily (morning and evening) for 8 weeks.
Mosapride Citrate
Mosapride citrate 5 mg tablets taken orally three times daily before meals for 8 weeks.
Locations (1)
Department of Colorectal Surgery, The First People's Hospital of Lin'an District, Hangzhou
Hangzhou, Zhejiang, China