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Immune inflammation induced by Treg/Th17 imbalance in nonalcoholic steatohepatitis patients and intervention effect of Jiangzhi Granules

The molecular mechanisms of Jiangzhikeli in treating nonalcoholic steatohepatitis via regulating Th17/Treg immunologic balance

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034583
Enrollment
Unknown
Registered
2020-07-10
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

nonalcoholic steatohepatitis

Interventions

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years, both genders; 2. Confirmed diagosis of NAFLD; 3. Biopsy-proven NASH or suspected NASH suggested by combination with metabolic syndrome, persistent elevation of serum ALT, or persistent elevation of CK-18; 4. Voluntary informed content and agreement of participating in every visit, examinations and treatment according to the protocol.

Exclusion criteria

Exclusion criteria: 1. ALT elevation above two times the upper limit of normal; 2. Combination with serious primary diseases and mental diseases, including but not limited to cardiovascular and cerebrovascular diseases, hepatic diseases, renal diseases, hematologic diseases, cancers; 3. Comination with type 2 diabetes; 4. Administration of immunosuppressors, PPAR-? agonists and lipid-lowering agents; 5. Allergy to compositions of experimental agents; 6. Pregnancy and lactation, and women who are likely to be pregnant but refuse to keep predefined contraception measures during the study; 7. Mental or legal disability.

Design outcomes

Primary

MeasureTime frame
HOMA-IR;

Secondary

MeasureTime frame
Peripheral blood T cell subsets;Serum cytokines;Serum adipocytokines;Transcription factor;Hepatic function;CK-18;Self-designed PRO scale;

Countries

China

Contacts

Public ContactWenjun Zhou

Shanghai University of Traditional Chinese Medicine

wjzhou678@163.com+86 021-64385700-9507

Outcome results

None listed

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