Treatment of non-alcoholic steatohepatitis with Tibetan drug Langqing Atar

A Multicenter, Double-blind, Placebo-randomized Controlled Clinical Study on the Treatment of Non-alcoholic Steatohepatitis With Tibetan Drug Langqing Atar

This study is testing a Tibetan drug called Langqing Atar to see if it can help people with non-alcoholic steatohepatitis (NASH) feel better compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Jinling Hospital, China (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06193629 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multicenter, double-blind, placebo-randomized controlled study aimed at evaluating the efficacy of Lang Qingata in treating non-alcoholic steatohepatitis (NASH). Participants aged 18 to 60 who meet the diagnostic criteria for NASH will be enrolled and randomly assigned to receive either the drug or a placebo. The primary endpoint is the overall clinical efficacy, with the study designed to compare the effective rates between the two groups. The trial aims to provide evidence for a potential new treatment option for NASH, a condition with limited current therapeutic options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 who have been diagnosed with non-alcoholic steatohepatitis.

Not a fit: Patients with liver cirrhosis, liver tumors, or severe liver function impairment will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from NASH.

How similar studies have performed: While there are few clinical reports on drug treatments for NASH, this approach is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Inclusion criteria: Participants must meet all of the following criteria to enter the trial.

  1. Signed written informed consent;
  2. Age 18-60 years old, gender is not limited;
  3. Meet the clinical diagnostic criteria for NASH; (See study content 3 Diagnostic criteria)
  4. The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale;
  5. Non-lactating pregnant women and no pregnancy plan during the test;
  6. Do not participate in any clinical trials for 3 months before and during the trial.

Exclusion Criteria:

1. \< 18 years old or \> 60 years old;
2. People who are allergic or allergic to the ingredients of this medicine;
3. Liver cirrhosis and liver tumor patients or ALT, AST≥ 5 times the normal upper limit, liver function damage is more serious This;
4. Women who are pregnant, breastfeeding or planning to become pregnant during the trial;
5. 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;
6. suffering from other serious diseases, such as tumors and other special blood diseases;
7. Poor compliance, unable to cooperate with the completion of the experiment.

Where this trial is running

Nanjing, Jiangsu

• A multicenter, double-blind, placebo-randomized controlled clinical study on the treatment of non-alcoholic steatohepatitis with Tibetan drug Langqing Atta — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: xuan ji

Conditions NASH