drugset / Trial / NCT03330184
Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level
Completed
300 enrolled
Xijing Hospital
Chang'An Hospital · collabGenertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd · collabSecond Affiliated Hospital of Xi'an Jiaotong University · collabShaanxi Aerospace Hospital · collabShangluo Central Hospital · collabXi'an Central Hospital · collabXi'an Gaoxin Hospital · collabYan'an People's Hospital · collabYan'an University Affiliated Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.
Timeline
- Start
- 2015-10
- Primary completion
- 2018-04
- Completion
- 2018-04
Outcome
Met primary endpoint
paper Significant reductions of FPG were observed in the Be and BB groups compared with the placebo group PMID 34365978 ↗
paper with a least square (LS) mean difference of - 0.50, 95% CI [- 0.85, - 0.15] mmol/L PMID 34365978 ↗
Publications
- Ming J, Yu X, Xu X, Wang L, Ding C, Wang Z, Xie X, Li S, Yang W, Luo S, He Q, Du Y, Tian Z, Gao X, Ma K, Fang Y, Li C, Zhao J, Wang X, Ji Q. Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study. Genome Med. 2021 Aug 9;13(1):125. doi: 10.1186/s13073-021-00942-7.
- Ming J, Xu S, Liu C, Liu X, Jia A, Ji Q. Effectiveness and safety of bifidobacteria and berberine in people with hyperglycemia: study protocol for a randomized controlled trial. Trials. 2018 Jan 26;19(1):72. doi: 10.1186/s13063-018-2438-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIFIDOBACTERIUM SPP. | Other / unclassified | — | — |
| Subject | Berberine | Traditional medicine (herbal / TCM) | — | — |
Indications
No indication recorded.