A Multicenter, Double-blind, Placebo-randomized Controlled Clinical Study on the Treatment of Non-alcoholic Steatohepatitis With Tibetan Drug Langqing Atar
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The total effective rate of Lang Qing Atta in the treatment of nonalcoholic steatohepatic NASH
研究概览
简要总结
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.
详细描述
Scheme introduction
- Test purpose A multi-center, prospective, double-blind, placebo-randomized controlled clinical trial was conducted to observe the total effective rate of Lang Qingata (observation group) and placebo (control group) through drug intervention in patients with nonalcoholic steatohepatitis, providing evidence for the treatment of patients with nonalcoholic steatohepatitis.
- Research the overall design 2.1 Overall design of the experiment Multicenter, prospective, double-blind, placebo-randomized controlled clinical trial.
2.2 Enrolled cases Patients ≥18 years of age and ≤60 years of age who meet the diagnostic criteria for NASH.
2.3 Basis for calculation of test sample size The study was a randomized, double-blind, placebo-controlled multicenter clinical study with overall clinical efficacy as the primary endpoint. According to previous research reports, the estimated effective rate of the placebo group was 50%, and the previous study of our group suggested that the effective rate of Lang Qingata was no less than 70%. Chi-square test will be used to compare the effective rate of the two groups (H0: π experimental group =π control group, H1: π experimental group ≠π control group), the test level α=0.05 (bilateral), the certainty is 80%, the sample size ratio of the experimental group and the control group is 1:1, assuming that the shedding rate is not more than 10%. According to the above parameters, the total sample size was estimated by PASS software to be 150 cases, including 75 cases in the experimental group and 75 cases in the control group.
2.4 Case grouping and case distribution plan Eligible subjects were assigned to Lang Qingata group and placebo group in a ratio of 1:1. Each group was intended to include 75 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •< 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.
研究组 & 干预措施
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.
干预措施: Lang Qingata (Drug)
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。
干预措施: placebo (Drug)
结局指标
主要结局
The total effective rate of Lang Qing Atta in the treatment of nonalcoholic steatohepatic NASH
时间窗: 2month
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
次要结局
- TCM syndrome integral(2month)
- ALP change from baseline(2month)
- BMI(2month)
- AST change from baseline(2month)
- Blood lipid levels(2month)
- Inflammatory cytokines(2month)
- Fasting blood glucose FPG(2month)
- GGT change from baseline(2month)
- B-ultrasound(2month)
- ALT change from baseline(2month)
- CT values of liver/spleen(2month)
研究者
Shupei Li
student
Jinling Hospital, China