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Clinical evaluation of Kang's "Ling-He Granules" in the treatment of obese metabolic-related fatty liver disease

Clinical evaluation of Kang's "Ling-He Granules" in the treatment of obese metabolic-related fatty liver disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006024
Enrollment
Unknown
Registered
2022-05-20
Start date
2022-05-19
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Metabolically associated fatty liver disease

Interventions

trial group:Chinese medicine ( Linghe granules ) granules
control group:Chinese medicine placebo granules

Sponsors

Xiamen Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Referring to diagnostic criteria for MAFLD based on the new definition of metabolic fatty liver disease in 2020, the diagnostic criteria of Phlegm, Dampness and Blood Stasis Syndrome established by the consensus opinion on the diagnosis and treatment of non-alcoholic fatty liver disease by integrated traditional Chinese and western medicine (2017) are as follows::?Age 18-60 years; ?Compliance with MAFLD (obesity type) diagnostic criteria and TCM phlegm, dampness, blood stasis syndrome diagnostic criteria; ?24=BMI 8 %, willing to accept regular physical and chemical examinations; ?Sign informed consent.

Exclusion criteria

Exclusion criteria: ?Alanine aminotransferase / aspartate aminotransferase > 5 × ULN ( standard upper limit ), total bilirubin > 2 × ULN; ?Alcoholic fatty liver disease; ?Combined with viral, autoimmune and other liver diseases, or taking drugs that may cause fatty liver; ?Combined with diabetes, malignant tumors, connective tissue diseases and severe heart, liver, hematopoietic, and nervous system complications , Or clearly have other important diseases; ?TCM Syndrome Differentiation of Liver and Kidney Yin Deficiency, Spleen and Kidney Yang Deficiency and Other Typical Deficiency Syndrome; ?Pregnant or breastfeeding women, allergic physique, allergic to drugs, and patients with mental illness; ?Patients who have undergone gastrointestinal bariatric surgery within the past year or who have taken weight-loss drugs within the past three months have lost >10%; ?Patients who took other therapeutic drugs in the past three months affected efficacy evaluation or participated in other clinical trials in the past month.

Design outcomes

Primary

MeasureTime frame
MRI PDFF;

Secondary

MeasureTime frame
Fibro Touch (CAP);weight;waist;blood fat;liver function;Uric Acid;blood glucose test;Self-made PRO Symptoms and Signs Scale;

Countries

China

Contacts

Public ContactCaihong

Xiamen Hospital of TCM

cguan2004@126.com15960263619

Outcome results

None listed

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