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Interventional Validation of Common and Specific Metabolic Substance Profiles of Damp-heat Syndrome in Chronic Hepatitis B and Nonalcoholic Fatty Liver Disease

Comparative study on metabolic network of damp-heat syndrome of Chronic Hepatitis B and Nonalcoholic Fatty Liver Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017884
Enrollment
Unknown
Registered
2018-08-20
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Interventions

observation group:Granules of Chinese Herb
control group:Placebo

Sponsors

Shuguang Hospital affiliated with Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Referring to the diagnostic criteria of CHB in the guidelines for the prevention and treatment of chronic hepatitis B published in 2015 and the diagnostic standard of NAFLD in the guide for the diagnosis and treatment of non-alcoholic fatty liver disease in 2010, the diagnostic criteria for Shi Re Pattern in 2002 "guidelines for clinical research of new drugs of traditional Chinese medicine" and the criteria for the diagnosis and diagnosis of the related documents: 1. Aged 18-60 years old male and female; 2. the elevation of serum alanine aminotransferase (ALT) and total bilirubin (Tbil) in patients with CHB diagnostic criteria was 2 times lower than the upper limit of the normal value; the elevation of serum alanine aminotransferase (ALT) or gamma glutamyl phthalase (gamma -GT) in patients with NAFLD diagnostic criteria was 2 times lower than the upper limit of the normal value; (1) Shi Re Pattern group: it accords with disease diagnosis standard and TCM damp heat syndrome standard; (2) Latent Pattern group: only meet the diagnostic criteria of disease, not meet the criteria of damp-heat syndrome and other syndromes of traditional Chinese medicine, no obvious clinical symptoms and signs; 3. normal control group: choose healthy volunteers with gender and age matched with case group; 4. I or guardian agreed to participate in the clinical trial control study and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) patients complicated with other hepatitis or severe hepatitis; (2) severe heart, liver, hematopoietic, nervous system complications and drug allergy; (3) malignant tumors, connective tissue diseases; (4) pregnant or lactating women; cases with other important diseases; (5) mental disorders.

Design outcomes

Primary

MeasureTime frame
metabolic substance;

Secondary

MeasureTime frame
liver function;kidney function;blood test;

Countries

China

Contacts

Public ContactZhang Hua

Shuguang Hospital affiliated with Shanghai University of TCM

lnutcmzh@126.com+86 021-20256520

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026