JRCT ID: jRCT1061200041
Registered date:25/12/2020
The usefulness of carnitine medication in patients with decompensated liver cirrhosis
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | decompensated liver cirrhosis with carnitine deficiency |
Date of first enrollment | 26/01/2021 |
Target sample size | 60 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Intervention group: L-carnitine 1500mg/day medication for 12 weeks. The dose increase and decrease is possible. non-intervention group: non administration of L-carinitine |
Outcome(s)
Primary Outcome | the improvement rate of Child-Pugh score |
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Secondary Outcome | the change of grasping power, serum ammonia, neuropsychological test,subjective symptom, increase or decrease medication, safety |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | The decompensated liver cirrhosis patients with Child-Pugh score over 7 points, and satisfy the following criteria. 1. over 20 years old 2. written informed consent 3. can periodically go to hospital |
Exclude criteria | 1. already take carinitine 2. The blood concentration of total carinitine and free carinitine is higher than the normal upper limit value 3. with a history of any hypersensitivity to ingredients in L-Cartin FF tablets and Levocarnitine FF tablets. 4. pregnant, unwilling to practice contraception during the study 5.. lactating female 6. The patient who received other study medicine or the clinical experimental medicine within three months before start of this study 7. The investigator judged to be inappropriate as the study subject |
Related Information
Primary Sponsor | Takaki Akinobu |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Takuya Adachi |
Address | 2-5-1 Shikata-cho, Kita-ku, Okayama Okayama Japan 700-8558 |
Telephone | +81-86-235-7219 |
adataku719@yahoo.co.jp | |
Affiliation | Okayama University Hospital |
Scientific contact | |
Name | Akinobu Takaki |
Address | 2-5-1 Shikata-cho, Kita-ku, Okayama Okayama Japan 700-8558 |
Telephone | +81-86-235-7219 |
akitaka@md.okayama-u.ac.jp | |
Affiliation | Okayama University Hospital |