Trial reportInternational journal of clinical practice2016
Efficacy and safety of ursodeoxycholic acid composite on fatigued patients with elevated liver function and/or fatty liver: a multi-centre, randomised, double-blinded, placebo-controlled trial.
Trial report in International journal of clinical practice, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02415777 (Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP.), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.
- Pharmacological interventions for non-alcohol related fatty liver disease (NAFLD): an attempted network meta-analysis.The Cochrane database of systematic reviews · 2017Pooled it
- Standard-Dose Ursodeoxycholic Acid Improves Biochemical Liver Function and Fibrosis in Chronic Liver Disease: Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.Journal of Korean medical science · 2026Trial
- Tauroursodeoxycholic acid: a potential therapeutic tool in neurodegenerative diseases.Translational neurodegeneration · 2022Review
- Ursodeoxycholic acid attenuates 5-fluorouracil-induced mucositis in a rat model.Oncology letters · 2018Article
- Corrigendum.International journal of clinical practice · 2017Article
Corrections and comments
- Erratum issuedCorrigendum.2017
Authors and funding
7 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimThe aim of this study was to assess the effects of ursodeoxycholic acid composite (URSA-S) on fatigue in patients with elevated liver function tests and/or fatty liver disease.
methodsIn this multi-centre randomised double-blinded placebo-controlled trial, 168 adults who were diagnosed with fatigue based on our criteria and had elevated liver function tests (but not > 5 times the normal level) and/or fatty liver on ultrasonography, were randomised to either the placebo or URSA-S administration group. The rate of improvement of checklist individual strength (CIS) using a cut-off of 76 points at the end of the study (8 weeks), the change in fatigue scale [CIS score and visual analogue scale (VAS)] were evaluated. The adverse effects of URSA-S were also recorded.
resultsThe rate of CIS improvement at the end-point was 79.76% and 45.68% in the therapy and placebo groups, respectively (p < 0.05). The fatigue recovery rate of the CIS score and VAS were higher in the therapy (-25.44 ± 18.57, -27.84 ± 2.70) than in the placebo group (-16.59 ± 17.29, -19.46 ± 2.81) (p < 0.05). The difference in fatigue recovery rate between the therapy and placebo groups was significant after 8 weeks. When analysed separately in patients with abnormal liver function tests and fatty liver disease, the fatigue recovery rate of the CIS score and VAS at 8 weeks was higher in the therapy than in the placebo group (p < 0.05). The frequency of adverse events in the therapy group was not significantly higher than that in the placebo group.
conclusionURSA-S is effective for alleviating fatigue in patients with liver dysfunction and/or fatty liver. The adverse effects of URSA-S are not significant. This study is registered at https://clinicaltrials.gov/ct2/show/NCT02415777.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.