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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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036224
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nonalcoholic fatty liver disease

Interventions

Sponsors

Longhua Hospital, Shanghai University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Controlled attenuation parameters;

Secondary

MeasureTime frame
liver function;blood fat;blood glucose;Fasting insulin;Intestinal flora;

Countries

China

Contacts

Public ContactYu Xiao

Longhua Hospital, Shanghai University of traditional Chinese Medicine

richie_xiao@163.com+86 13661956043

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026