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Clinical effect evaluation of Lanzhang granules on spleen deficiency and Phlegm stasis syndrome of non-alcoholic fatty liver disease : a randomized, double-blind, placebo-controlled clinical trial

Clinical effect evaluation of Lanzhang granules on spleen deficiency and Phlegm stasis syndrome of non-alcoholic fatty liver disease : a randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061642
Enrollment
Unknown
Registered
2022-06-30
Start date
2022-06-16
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

NAFLD

Interventions

Lanzhang group:Lanzhang granules

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, no gender limitation; 2. Meet the western diagnostic criteria of NAFLD; 3. It conforms to the dialectical standard of spleen deficiency and phlegm stasis; 4. The patients agreed to participate in the clinical study, voluntarily signed the informed consent, and agreed to participate in all visits, examinations and treatment according to the requirements of the study protocol.

Exclusion criteria

Exclusion criteria: 1. With alcoholic liver disease (ALD), viral hepatitis, autoimmune liver disease, hepatolenticular degeneration and other specific liver diseases that can lead to fatty liver; 2. Drugs such as tamoxifen, ethylamine iodic cefuroxime ketone, valproate, methotrexate, glucocorticoids, etc.), total parenteral nutrition, inflammatory bowel disease, hypothyroidism, Cushing heald table sign, lack of beta lipoprotein hematic disease, as well as some associated with insulin resistance syndrome (lipid atrophic diabetes, Mauriac heald Taiwan) caused by such as fatty liver; 3. Patients with cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other serious primary diseases, malignant tumors, other serious complications or mental illness; 4. Patients with diabetes or receiving anti-diabetes drugs; 5. Patients using NAFLD treatment drugs (including TCM decoction, Chinese patent medicine and chemical drugs) and ALT > 1.5 times standard value; 6. Patients who have taken or are taking antibiotics within the last 1 month; 7. Known to be allergic to the composition of the study product, or allergic constitution; 8. Pregnant and lactating women, and women at risk of becoming pregnant who refused to maintain the researcher's approved contraceptive methods throughout the study; 9. Persons who have participated in other clinical trials or are currently participating in other clinical trials in the last 3 months; 10. Patients with mental or legal disabilities; 11. Failure to follow medical advice to treat changes in sexual lifestyle; 12. Qiu suspected of having a history of drug abuse or other ineligible patients.

Design outcomes

Primary

MeasureTime frame
alanine transaminase;aspartate transaminase;triglyceride;Total cholesterol;fasting blood-glucose;

Countries

China

Contacts

Public ContactYu Xiao
richhie_xiao@163.com+86 13661956043

Outcome results

None listed

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