Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution

Summary

The prevention and treatment of metabolic-related fatty liver disease (MAFLD) involves many fields in preventive medicine and clinical medicine. So far, western medicine has not yet completed the elucidation of the mechanism of this type of disease, and there is a lack of effective therapeutic drugs.The purpose of this study was to evaluate the effectiveness and safety of limonene capsules (marketed product in China) in the treatment of metabolic-related fatty liver disease and related lipid-lowering mechanisms.

Conditions

• Fatty Liver

Interventions

DRUG

Limonene capsule

All the recruiters will be given treatment under the guidance of basic diet. Basic dietary guidelines include high-quality protein and fresh green leafy vegetables. It need to controlled sugar, various sweets and high-calorie foods, frying and other foods with high oil content and foods with high cholesterol content. Limonene capsules group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo control group and limonene capsule administration group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the treatment group and the placebo control group at a ratio of 1:1. The drug was administered for 12 weeks, 3 times a day, 5 capsules each time.

DRUG

Limonene capsules(Placebo)

Limonene capsules(Placebo)

Sponsors & Collaborators

• Shanghai Shen Kang Hospital Development Center

  collaborator OTHER

• Longhua Hospital

  collaborator OTHER

• Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Faculty of Public Health, Shanghai Jiao Tong University School of Medicine

  collaborator UNKNOWN

• Hongsheng Tan

  lead OTHER

Principal Investigators

• Biyun Qian, Doctor · Shanghai Shen Kang Hospital Development Center;Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Faculty of Public Health, Shanghai Jiao Tong University School of Medicine

• Xiaoyun Chen, Doctor · Longhua Hospital

• Hongsheng Tan, Doctor · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-22

Primary Completion

2021-10-25

Completion

2021-10-25

Countries

• China

Study Locations