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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 increase. In the early stage, NASH generally has no obvious symptoms. With the progression of the disease and the aggravation of liver damage, it may induce fatigue, loss of body mass, and pain in the right upper abdomen, which seriously affects the health of patients. There are no specific drugs to treat NASH in clinical practice. Increasing exercise, taking drugs to avoid liver damage, controlling diet and other methods can alleviate clinical symptoms to a certain extent, but the stability of disease control is poor, and it is easy to develop into cirrhosis, threatening the life safety of patients. However, there are few clinical reports on the effect of drugs on NASH. In the previous treatment of patients with liver fibrosis, our research group found that non-alcoholic steatohepatitis NASH induced liver fibrosis has a good effect, suggesting that Langqingata may improve NASH. Based on this, this study observed the total effective rate of Lang Qingata in the treatment of nonalcoholic steatohepatic NASH.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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• 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.

Locations
Other Locations
China
A multicenter, double-blind, placebo-randomized controlled clinical study on the treatment of non-alcoholic steatohepatitis with Tibetan drug Langqing Atta
RECRUITING
Nanjing
Contact Information
Primary
xuan ji
helio0009@126.com
02580864222
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 150
Treatments
Experimental: Lang Qingata
Lang Qingata: (Artificial bezoar: 0.1g, Safflower: 15g, five spirit fat: 15g, Tangerine: 30g, Swertia: 15g, nutmeg: 10g, Astragalus: 25g, wood fragrance: 10g, Parasol tiger grass: 15g, Coriander fruit: 10g, Agarwood: 3g, pomegranate seed: 20g, Rhododendron: 8g, Dongquai fruit: 15g, licorice: 10g). Water decoction (hospital decoction), Decoction in water for oral use,2 times/day, 4 weeks for a course of treatment.
Placebo_comparator: placebo group
Placebo is a Chinese medicine granule with 5% active ingredient and has the same taste as Lang Qingata,Decoction in water for oral use。
Sponsors
Leads: Shupei Li

This content was sourced from clinicaltrials.gov