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NCT05523648

Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD

Completed EARLY_PHASE1 Last updated 31 August 2022
What this trial tests

EARLY_PHASE1 trial testing Chronic Hepatitis B in Chronic Hepatitis B in 92 participants. Completed in 21 December 2021.

Timeline
5 January 2020
Primary endpoint
20 December 2021
21 December 2021

Quick facts

Lead sponsorSichuan Leshan Traditional Chinese Medicine Hospital
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment92
Start date5 January 2020
Primary completion20 December 2021
Estimated completion21 December 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sichuan Leshan Traditional Chinese Medicine Hospital

Who can join

Adults 20 to 55, any sex, with Chronic Hepatitis B or Nonalcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The changes in liver function, body mass index, controlled attenuation parameters, liver stiffness and HBV-DNA at different time points in each group before and after treatment were counted to explore the clinical efficacy of Ganshuang granules combined with tenofovir in the treatment of CHB complicated with NAFLD.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeted modulation of gut microbiota by traditional Chinese medicine and natural products for liver disease therapy.
    Zhu LR, Li SS, Zheng WQ, Ni WJ, et al · · 2023 · cited 41× · PMID 36817459 · DOI 10.3389/fimmu.2023.1086078
  2. Clinical study of ganshuang granule combined with tenofovir in the treatment of chronic hepatitis B complicated with nonalcoholic fatty liver disease.
    Su C, Yang Q. · · 2022 · cited 2× · PMID 36588741 · DOI 10.3389/fphar.2022.1032789

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Other recruiting trials for Chronic Hepatitis B

Currently open trials in the same condition.

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Data sources for this page

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