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Randomized controlled clinical evaluation of Sijunzi Decoction in the treatment of nonalcoholic fatty liver disease with spleen deficiency syndrome based on the theory of

Phase 1
Conditions
nonalcoholic fatty liver disease
Registration Number
ITMCTR2000003627
Lead Sponsor
onghua Hospital, Shanghai University of traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Those who sign the informed consent form;
(2) The age ranged from 18 to 65 years old;
(3) It met the diagnostic criteria of NAFLD in western medicine;
(4) TCM Syndrome Differentiation for spleen deficiency syndrome patients.

Exclusion Criteria

(1) Drug-induced liver injury, autoimmune hepatitis A, B, C, e, etc;
(2) Patients wit
h severe primary diseases of heart, brain, kidney, lung, endocrine, blood, metabolism and gastrointestinal tract, or mental patients;
(3) Creatinine (CR) was higher than the upper limit of normal value;
(4) People who use drugs to lose weight;
(5) Alcoholics or drug addicts;
(6) Pregnant women, lactating women or those who are preparing for pregnancy in the near future and those who use estrogen contraception;
(7) People with allergic constitution and allergic to many kinds of drugs, as well as the components of this medicine or its prescription;
(8) Those who are in critical condition and are difficult to evaluate the efficacy and safety of new drugs;
(9) Patients are not willing to cooperate.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Controlled attenuation parameters;
Secondary Outcome Measures
NameTimeMethod
blood fat;Fasting insulin;liver function;Intestinal flora;blood glucose;
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