A randomized controlled trial for the efficacy and safety of Gan-Jiang Ling-Zhu decoction in the treatment of lean nonalcoholic fatty liver disease with pattern of ''yang deficiency and fluid retention''

Phase 1

• Conditions: nonalcoholic fatty liver disease

• Registration Number: ITMCTR2000003584
• Lead Sponsor: onghua Hospital, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. aged 18-70 years old;
2. Meet the diagnostic criteria of nonalcoholic fatty liver disease;
3. Meet the diagnostic criteria of pattern of yang deficiency and fluid retention;
4. BMI<23kg/m2
5. Agree to participate in this clinical study, voluntarily sign the informed consent, and agree to participate in all visits, examinations and treatments as required by the study plan.

Exclusion Criteria

1. Patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, renal diseases, hematopoietic diseases, malignant tumors, and other serious complications or mental diseases;
2. Patients with type 1 diabetes or uncontrolled type 2 diabetes, defined as HbA1c>=9.5%, or adjustment of anti-diabetes drugs in recent two months before enrollment, or history of severe hypoglycemia;
3. Severe hepatic injury, defined as ALT>=3 ULN;
4. Severe renal injury, defined as Scr>=178umol/L or eGFR<60;
5. Combined with thyroid diseases, including hyperthyroidism, hypothyroidism, sub-clinical hypothyroidism;
6. Suggestive existence of cirrhosis or hepatic function decompensation;
7. Known allergic to the components of the research product;
8. Pregnant and lactating women, and those who refused to maintain the contraceptive methods approved by the researchers throughout the study;
9. Participation in other clinical trials in recent 3 months;
10. Cannot follow the researcher's instructions for lifestyle intervention
11. History of drug abuse or other conditions.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Controlled attenuation parameter;

Secondary Outcome Measures

Name	Time	Method
Hepatic function;Adipocytokines;HOMA-IR;hs-CRP;Liver stiffness measurement;Body measurements;Blood lipids metabolism;