Clinical TrialID 6759

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

NCT04853082

Fatty Liver

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
6759
Evidence Id
6759
Core Evidence Id
6759
Source Clinical Trial Id
6749
Herb2 Clinical Trial Id
HBCT006749
Nct Id
NCT04853082
Title
Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution
Status
Completed
Phase
Early_Phase 1
Study Result
No
Study Condition
Fatty Liver
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Limonene capsule|DRUG: Limonene capsules(Placebo)
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
57
Outcome Measure
Difference of controlled attenuation parameter (CAP) in liver fat, Changes in controlled attenuation parameter (CAP) in liver fat measured with transient elastography between the drug group and the placebo group., at baseline and twelve weeks after administration|Difference of rate of BMI index, The percent change of BMI index between the drug group and the placebo group., at baseline, four, twelve weeks after administration
Sponsor Collaborator
Hongsheng Tan|Shanghai Shen Kang Hospital Development Center|Longhua Hospital|Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Faculty of Public Health, Shanghai Jiao Tong University School of Medicine
Funded By
OTHER
Location
Longhua Hospital, Shanghai, Shanghai, 200032, China
Other Id
DL-MAFLD-TCM|SHDC2020CR4095
Start Date
2021-02-22
Primary Completion Date
2021-10-25
Completion Date
2021-10-25
First Posted
2021-04-21
Results First Posted
Last Update Posted
2021-11-02
Study Document
Study Url
https://clinicaltrials.gov/study/NCT04853082
Title Cn
Title En
Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution
Bilingual Status
semi_complete