Skip to content

A large sample, multicenter, randomized controlled trial of Xiaomudan in the treatment of nonalcoholic steatohepatitis (spleen deficiency and phlegm and blood stasis)

A large sample, multicenter, randomized controlled trial of Xiaomudan in the treatment of nonalcoholic steatohepatitis (spleen deficiency and phlegm and blood stasis)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050145
Enrollment
Unknown
Registered
2021-08-18
Start date
2021-08-18
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Non-alcoholic Steatohepatitis

Interventions

Sponsors

Affiliated Hospital of Shaanxi University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18-65 years; 2. Those who meet the diagnostic criteria of Western medicine for non-alcoholic steatohepatitis, those with TCM syndrome differentiation of spleen deficiency and phlegm and blood stasis, and outpatients who can control the variable factors; 3. The ALT or AST or GGT value was greater than the upper limit of the normal value, but less than 3 times; TBIL was less than 2 times the upper limit of the normal value; 4. Liver CT showed liver/spleen CT ratio 0.5; 5. Those who have not participated in other clinical trials within 1 month; 6. Those who have not taken other drugs related to this disease within 2 weeks; 7. Informed consent, voluntary experiment. The process of obtaining informed consent conforms to GCP regulations.

Exclusion criteria

Exclusion criteria: 1. Combined with coronary heart disease, cardiomyopathy, and cardiac function grades I-II; 2. Combined with uncontrolled hypertension and diabetes; 3. Pregnant and lactating patients, mentally ill patients; 4. Allergic constitution, or those who are known to be allergic to such drugs or drug ingredients; 5. Combined with severe heart, cerebrovascular disease, kidney disease, liver disease, blood system disease, lung disease, or serious diseases that affect their survival; 6. According to the judgment of the investigator, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment. For example, the workplace is often changed to cause loss to follow-up.

Design outcomes

Primary

MeasureTime frame
The ratio of liver and spleen value;

Secondary

MeasureTime frame
Hepatic function;Blood Lipids;TCM syndrome score;

Countries

China

Contacts

Public ContactLi Jingtao

Affiliated Hospital of Shaanxi University of Chinese Medicine

lijingtao555@163.com+86 18291093720

Outcome results

None listed

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