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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''

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''

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035798
Enrollment
Unknown
Registered
2020-08-17
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

nonalcoholic fatty liver disease

Interventions

Experimental group:Gan-Jiang Ling-Zhu decoction
Placebo group:Placebo

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Controlled attenuation parameter;—

Secondary

MeasureTime frame
Liver stiffness measurement;Hepatic function;Blood lipids metabolism;HOMA-IR;hs-CRP;Adipocytokines;Body measurements;—

Countries

China

Contacts

Public ContactZhang Li

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

zhangli.hl@163.com+86 18930362723

Outcome results

None listed

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