|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
18 April 2017 |
|
Main ID: |
ChiCTR-IIR-16009114 |
|
Date of registration:
|
2016-08-29 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The effect of high concentration of hydrogen inhalation on non-alcoholic fatty liver disease in community
|
|
Scientific title:
|
The effect of high concentration of hydrogen inhalation on non-alcoholic fatty liver disease in community |
|
Date of first enrolment:
|
2016-09-01 |
|
Target sample size:
|
treatment group:40;control group:40; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=15145 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
Other
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Song Guohua
|
|
Address:
|
2 East Yingsheng Road, Taishan District, Tai'an, Shandong, China
271000
|
|
Telephone:
|
+86 18653832698 |
|
Email:
|
16089624@qq.com |
|
Affiliation:
|
Taishan Medical University |
|
|
Name:
|
Qin Shucun
|
|
Address:
|
2 East Yingsheng Road, Taishan District, Tai'an, Shandong, China
271000
|
|
Telephone:
|
+86 0538 6222986 |
|
Email:
|
shucunqin@hotmail.com |
|
Affiliation:
|
Taishan Medical University |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. aged 30-70 years old;
2. NAFLD patients meet the diagnosis criteria according to: The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association);
3. The patients agreed to participate in the study and signed the informed consent.
Exclusion criteria: 1) fatty liver caused by a specific cause, such as tamoxifen;
2) combined with other causes of liver disease such as viral hepatitis (such as HBsAg or anti HCV positive), liver cirrhosis, drug-induced liver injury, autoimmune diseases, metabolic liver disease, etc;
3) Alcohol abuse, alcohol consumption >70g/week for female patient or >140g/week for male patient;
4) Patient who is receiving insulin treatment;
5) patients with severe disease of other system, mental disease, or senile dementia patients, epilepsy patients; hypothyroidism or Cushing's syndrome;
6) Have received Levocarnitine treatment within 30 days; Hypersensitive to Levocarnitine and its derivatives;
7) Patient has participated in other drug clinical trial within 30 days;
8) use of drugs such as calcium channel blockers, high dose of synthetic estrogens, methotrexate, amiodarone steroids, chloroquine;
9) Pregnant or lactating female, or female of childbearing potential does not use adequate contraceptive methods;
10) other situations that researchers think the patient is not suitable for the research.
Age minimum:
30
Age maximum:
70
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
non-alcoholic fatty liver disease
|
|
Intervention(s)
|
|
treatment group:aerosol inhalation with hydrogen and oxygen;control group:aerosol inhalation with nitrogen and oxygen;
|
|
Primary Outcome(s)
|
|
ALT level;AST level;L/S ratio;
|
|
Secondary Outcome(s)
|
|
TG;TC;BMI;abdomen circumference;Fasting blood glucose;HDL-C;LDL-c;
|
|
Source(s) of Monetary Support
|
|
Special fund by ascleplus meditec in Shang hai
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|