Unique ID issued by UMIN | UMIN000009265 |
---|---|
Receipt number | R000008950 |
Scientific Title | The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial |
Date of disclosure of the study information | 2012/11/10 |
Last modified on | 2019/03/07 11:39:59 |
The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial
Japan |
nonalcoholic fatty liver disease/nonalcoholic steatohepatitis
Hepato-biliary-pancreatic medicine | Dental medicine |
Others
NO
To demonstrate the efficacy and safety of azithromycin for the treatment of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver
Safety,Efficacy
Exploratory
Phase III
improvement of liver function test
improvement of histological findings of the liver
Interventional
Factorial
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Placebo
2
Treatment
Medicine |
medical drug
placebo
20 | years-old | <= |
80 | years-old | > |
Male and Female
1, NAFLD/NASH with P.gingivalis infection in the liver
2, Patients between 20 years old and older than that, and age less than 80 years old.
3, Patients who agreed to participate in this study.
1, Patients with alcoholic liver diseases.
2,Patients with viral liver diseases, autoimmune hepatitis, and primary biliary cirrhosis.
3, Paitents with pregnancy.
4, Patients who have allergy against ingredients of azithromicin.
5, Patients who have allergy against other macrolides and ketolides.
6, Patients with liver cirrhosis,liver failure including severe liver function test, hepatocellular carcinoma in the liver and other organs.
7, Patients with severe heart diseases.
8, Patients with hereditary fructose intolerance, glucose-galactose malabsorption, and sucrase-isomaltase deficiency.
9, Medical doctors decided the patients inappropriate.
44
1st name | |
Middle name | |
Last name | Kazuaki Chayama |
Hiroshima University Hospital
Gastroenterology and Metabolism
1-2-3 Kasumi, Minamiku, Hiroshima, 734-8551, Japan
082-257-5191
1st name | |
Middle name | |
Last name | Hideyuki Hyogo |
Hiroshima University Hospital
Gastroenterology and Metabolism
hidehyogo@hiroshima-u.ac.jp
Hiroshima University Hospital
self funding
Self funding
NO
広島大学病院(広島県)
2012 | Year | 11 | Month | 10 | Day |
Unpublished
Terminated
2012 | Year | 10 | Month | 01 | Day |
2012 | Year | 11 | Month | 10 | Day |
2014 | Year | 09 | Month | 30 | Day |
2012 | Year | 11 | Month | 05 | Day |
2019 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008950