Status:
RECRUITING
A Multicenter, Double-blind, Placebo-randomized Controlled Clinical Study on the Treatment of Non-alcoholic Steatohepatitis With Tibetan Drug Langqing Atar
Lead Sponsor:
Shupei Li
Conditions:
NASH
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
non-alcoholic steatohepatitis (NASH) is an inflammatory liver disease caused by the accumulation of fat in liver cells. With the change of living habits and diet, the incidence of Nash continues to in...
Detailed Description
Scheme introduction 1. Test purpose A multi-center, prospective, double-blind, placebo-randomized controlled clinical trial was conducted to observe the total effective rate of Lang Qingata (observat...
Eligibility Criteria
Inclusion
- Inclusion criteria: Participants must meet all of the following criteria to enter the trial.
- Signed written informed consent;
- Age 18-60 years old, gender is not limited;
- Meet the clinical diagnostic criteria for NASH; (See study content 3 Diagnostic criteria)
- The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale;
- Non-lactating pregnant women and no pregnancy plan during the test;
- Do not participate in any clinical trials for 3 months before and during the trial.
Exclusion
- \< 18 years old or \> 60 years old;
- People who are allergic or allergic to the ingredients of this medicine;
- Liver cirrhosis and liver tumor patients or ALT, AST≥ 5 times the normal upper limit, liver function damage is more serious This;
- Women who are pregnant, breastfeeding or planning to become pregnant during the trial;
- Complicated with viral hepatitis, alcoholic hepatitis, autoimmune liver disease and cirrhosis, liver cells Patients with other liver diseases such as cancer, serious heart, brain, and kidney diseases, such as chronic cardiac insufficiency;
- suffering from other serious diseases, such as tumors and other special blood diseases;
- Poor compliance, unable to cooperate with the completion of the experiment.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06193629
Start Date
March 1 2024
End Date
December 31 2024
Last Update
March 26 2024
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A multicenter, double-blind, placebo-randomized controlled clinical study on the treatment of non-alcoholic steatohepatitis with Tibetan drug Langqing Atta
Nanjing, Jiangsu, China, 210000