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A Study on the Efficacy and Gut Microbiota of Berberine and Probiotics in Patients With Newly Diagnosed Type 2 Diabetes

NCT02861261 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-02-12

No results posted yet for this study

Summary

The purpose of this study is to conduct a multicenter randomized, double-blind, placebo-controlled clinical trial, evaluating the effects and change of gut microbiota after berberine and/or probiotics administration in patients with newly diagnosed type 2 diabetes

Conditions

Interventions

DRUG

1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder

1. 0.6g (6 pills) of Berberine tablets administered twice a day orally before meal ; 2. 4g (2 strips) of ProMetS probiotics powder administered orally every night

DRUG

1. Berberine placebo tablets ; 2. ProMetS probiotics powder

1. 6 pills of Berberine placebo tablets administered twice a day orally before meal; 2. 4g (2 strips) of ProMetS probiotics powder administered orally every night

DRUG

1. Berberine hydrochloride tablets; 2. Probiotics placebo powder

1. 0.6g (6 pills) of Berberine tablets administered twice a day orally before meal; 2. 2 strips of probiotics placebo powder administered orally every night

DRUG

1. Berberine placebo tablets; 2. Probiotics placebo powder

1. 6 pills of Berberine placebo tablets administered twice a day orally before meal; 2. 2 strips of probiotics placebo powder administered orally every night

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-18
Primary Completion
2017-12-31
Completion
2019-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02861261 on ClinicalTrials.gov