Efficacy and Safety of HuHuangLianzonggan Capsule in Subjects With Nonalcoholic steatoHEPAtitis: a Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 tRial(HHL-HEPAR)

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Males and females between 18-75 years of age inclusive(including boundary values).

• Must have had a liver biopsy proven NASH within 6 months or in screening test. The following two requirements must be met at the same time: ① a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components: Steatosis≥1, Lobular inflammation≥1, Ballooning degeneration≥1;② fibrosis stage 1 to 3.

• Must have confirmation of ≥ 8% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.

• No alcohol consumption or history of excessive alcohol consumption: less than 210 g of ethanol per week for men and 140 g for women in the past 12 months.

• Patients who are taking chronic drugs(including but not limited to antihypertensive drugs, antiatherogenic drugs, oral hypoglycemic drugs, insulin) need to have a steady dose for at least 3 months before liver biopsy.

• Weight was stable(the change is no more than 5%) during the 6 months prior to Screening.

• No attempt to change lifestyle (diet and/or exercise) during the 3 months prior to Screening.

• Ability to understand the requirements of the study and willingness to provide written informed consent.

• Have no pregnancy program and take effective contraceptive measures voluntarily.

⁃ Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment.

Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The first affiliated hospital of Fujian medical university
NOT_YET_RECRUITING
Fuzhou
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITING
Guangzhou
The Affiliated Hospital of Hangzhou Normal University
RECRUITING
Hangzhou
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
The Second Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
The First People's Hospital of Lianyungang
RECRUITING
Lianyungang
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
The Affiliated Hospital of Nanjing University medical school,Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
The Second Hospital of Nanjing
RECRUITING
Nanjing
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
RECRUITING
Ningbo
Ningbo Medical Center Lihuili Hospital
RECRUITING
Ningbo
The Third People's Hospital of Shenzhen
RECRUITING
Shenzhen
Taizhou Municipal Hospital
RECRUITING
Taizhou
Tianjin Second People's Hospital
RECRUITING
Tianjin
Rui'an People's Hospital
RECRUITING
Wenzhou
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
General Hospital of Ningxia Medical University
NOT_YET_RECRUITING
Yinchuan
Time Frame
Start Date: 2023-02-21
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 76
Treatments
Experimental: Experimental group
HuHuangLianzonggan capsule, 4 pills, take orally after meals, 2 times a day
Placebo_comparator: Placebo group
HuHuangLianzonggan capsule placebo, 4 pills, take orally after meals, 2 times a day
Sponsors
Leads: Tasly Pharmaceutical Group Co., Ltd

This content was sourced from clinicaltrials.gov