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

NCT06193629 | Recruiting

• 1 other identifier: DZQH-KYLLFS-23-25
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

NASH

Outcome Measures

Primary Outcomes (1)

• The total effective rate of Lang Qing Atta in the treatment of nonalcoholic steatohepatic NASH

  Total effective rate of clinical effect = (cure + obvious + effective) cases/total cases ×100%.The criteria for cure, efficacy, and effectiveness are described in the study

  2month

Secondary Outcomes (11)

• BMI

  2month

• B-ultrasound

  2month

• AST change from baseline

  2month

• Blood lipid levels

  2month

• Inflammatory cytokines

  2month

Study Arms (2)

Lang Qingata

EXPERIMENTAL

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.

Drug: Lang Qingata

placebo group

PLACEBO COMPARATOR

Placebo is a Chinese medicine granule with 5% active ingredient and has the same taste as Lang Qingata，Decoction in water for oral use。

Drug: placebo

Interventions

Lang Qingata DRUG

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.

Lang Qingata

placebo DRUG

Placebo is a Chinese medicine granule with 5% active ingredient and has the same taste as Lang Qingata，Decoction in water for oral use

placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Shupei Li: lead

Study Sites (1)

A multicenter, double-blind, placebo-randomized controlled clinical study on the treatment of non-alcoholic steatohepatitis with Tibetan drug Langqing Atta

Nanjing, Jiangsu, 210000, China

RECRUITING

Central Study Contacts

xuan ji

CONTACT

02580864222; helio0009@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: student

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)