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A Randomized, Double-Blind, Double-Simulated, Parallel-Controlled Clinical Study on the Regulation of ApoA1/LCAT Activity by Xinjia Linggui Yinchen Decoction in the Treatment of Obese MAFLD (Spleen Deficiency and Liver Depression,Turbid Yin Condensation )

A Randomized, Double-Blind, Double-Simulated, Parallel-Controlled Clinical Study on the Regulation of ApoA1/LCAT Activity by Xinjia Linggui Yinchen Decoction in the Treatment of Obese MAFLD (Spleen Deficiency and Liver Depression,Turbid Yin Condensation )

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079102
Enrollment
Unknown
Registered
2023-12-26
Start date
2023-12-31
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Metabolic related fatty liver disease

Interventions

Control Group:Oral Western medicine and traditional Chinese medicine simulation dosage forms were taken for a total of 8 weeks.
Test Group:Oral Chinese medicine and Western medicine simulation dosage forms were taken for a total of 8 weeks.

Sponsors

Dongfang Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1: Western medicine diagnostic criteria in line with overweight / obesity with abnormal liver function of MAFLD. 2: Dyslipidemia, including one of the following three cases : total cholesterol ( TC ) = 6.2mmol / L , low density lipoprotein cholesterol ( LDL-C ) = 4.1mmol / L , high density lipoprotein cholesterol ( HDL-C ) < 1.0mmol / L. 3: TCM diagnostic criteria in line with the spleen deficiency and liver depression, turbidity Yin coagulation syndrome. 4: Aged 18-65 years old. 5: Patients who did not receive similar drug treatment within 2 weeks before the trial ( including MAFLD patients who had been taking antihypertensive and lipid-lowering drugs ). 6: Those who volunteered to participate in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1: MAFLD patients with type 2 diabetes diagnosed by Western medicine and MAFLD patients with normal / lean BMI and metabolic abnormalities. 2: Liver enzymes ( ALT, AST ) increased > 3 times ULN and / or total bilirubin increased ( > 17.1umol / L ). 3: Patients with a history of liver disease and fatty liver disease not belonging to MAFLD ( such as acute fatty liver of pregnancy, encephalopathy fatty liver syndrome, lipid deposition disease, liver fat tumors, alcoholic liver disease, fatty liver caused by viral liver disease, etc. ). 4: Patients with severe lesions of brain, kidney and other major organs, mental illness. 5: Patients with hypertension, hyperlipidemia and abnormal liver function who had received treatment. 6: Pregnant women and lactating women. 7: Patients who had used other MAFLD drugs within 2 weeks before screening. 8: Allergic constitution, and allergies to the known components of the drugs in this study, any excipients. 9: Those with a history of drug abuse. 10: Those who participated in other clinical trials within three months.

Design outcomes

Primary

MeasureTime frame
liver function;blood fat;

Secondary

MeasureTime frame
Liver fat attenuation;chinese medicine syndrome scores;Epigastric ultrasound;

Countries

China

Contacts

Public ContactWang Yunliang

Dongfang Hospital, Beijing University of Chinese Medicine

yunliang_wang@sina.com+86 158 0143 4310

Outcome results

None listed

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