Non-alcoholic fatty liver disease
Conditions
Interventions
Treatment group:Ganjianglingzhu extract powder, 8g per packet, orally, 1 packet a day, for 24 weeks
Control group:Placebo of Ganjianglingzhu extract powder, 8g per packet, orally, 1 packet a day, for 24 weeks
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ? Age 18-70 years old (inclusive), no gender limitation; ? Meet the diagnostic criteria of Western medicine for NAFLD; ? Spleen deficiency syndrome PRO score =20; ? BMI < 24kg/m2; ? CAP value determined by Fibroscan =238dB/m; ? The patient agreed to join the clinical study, voluntarily signed the informed consent, and agreed to participate in all visits, examinations, and treatments according to the requirements of the research protocol.
Exclusion criteria
Exclusion criteria: ? Patients with serious primary diseases such as cardiovascular and cerebrovascular, urinary and hematopoietic systems, malignant tumors, other serious comorbidities or mental disorders; ? Combined with type 1 diabetes or uncontrolled type 2 diabetes, defined as HbA1c=9.5%, or adjusted hypoglycemic drugs 2 months before enrollment, or had a history of severe hypoglycemic events; ? Severe liver function injury, defined as glutamic-pyruvic transaminase (ALT)=3 times the upper limit of normal; ? Severe renal insufficiency, defined as serum creatinine (Scr)=178µmol/L, or glomerular filtration rate (eGFR)< 60; ? Combined with thyroid disease, including hyperthyroidism, hypothyroidism, subclinical hypothyroidism; ? Clinical evidence of cirrhosis or liver decompensation; ? People who are known to be allergic to the components of the investigational product; ? Pregnant and lactating women, and women with the possibility of becoming pregnant who refused to maintain investigator-approved contraception throughout the study; ? Participated in other clinical trials in the past 3 months; ? Those who cannot follow medical advice to implement lifestyle interventions; ? Persons suspected of having a history of drug abuse or who do not meet other eligibility criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Controlled attenuation parameter (CAP) values determined by Fibroscan; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver stiffness measurement (LSM) values determined by Fibroscan;Liver function (AST, ALT, GGT);Blood lipid(TG, TC, LDL-C, HDL-C);hs-CRP;HOMA-IR;Body measurement (BMI, WHR);Spleen deficiency syndrome PRO scale score; | — |
Countries
China
Contacts
Public ContactLi Zhang
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine; Institute of Digestive Diseases, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed