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Clinical Trials/ITMCTR2000003584
ITMCTR2000003584Not yet recruitingPhase 1

A randomized controlled trial for the efficacy and safety of Gan-Jiang Ling-Zhu decoction in the treatment of lean nonalcoholic fatty liver disease with pattern of ''yang deficiency and fluid retention''

onghua Hospital, Shanghai University of Traditional Chinese Medicine0 sitesStarted: TBDLast updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional study

Eligibility Criteria

Ages
18 to 70 (—)
Sex
All

Inclusion Criteria

  • 1. aged 18-70 years old;
  • 2. Meet the diagnostic criteria of nonalcoholic fatty liver disease;
  • 3. Meet the diagnostic criteria of pattern of yang deficiency and fluid retention;
  • 4. BMI<23kg/m2
  • 5. Agree to participate in this clinical study, voluntarily sign the informed consent, and agree to participate in all visits, examinations and treatments as required by the study plan.

Exclusion Criteria

  • 1. Patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, renal diseases, hematopoietic diseases, malignant tumors, and other serious complications or mental diseases;
  • 2. Patients with type 1 diabetes or uncontrolled type 2 diabetes, defined as HbA1c>=9.5%, or adjustment of anti-diabetes drugs in recent two months before enrollment, or history of severe hypoglycemia;
  • 3. Severe hepatic injury, defined as ALT>=3 ULN;
  • 4. Severe renal injury, defined as Scr>=178umol/L or eGFR<60;
  • 5. Combined with thyroid diseases, including hyperthyroidism, hypothyroidism, sub-clinical hypothyroidism;
  • 6. Suggestive existence of cirrhosis or hepatic function decompensation;
  • 7. Known allergic to the components of the research product;
  • 8. Pregnant and lactating women, and those who refused to maintain the contraceptive methods approved by the researchers throughout the study;
  • 9. Participation in other clinical trials in recent 3 months;
  • 10. Cannot follow the researcher's instructions for lifestyle intervention
  • 11. History of drug abuse or other conditions.

Investigators

Sponsor
onghua Hospital, Shanghai University of Traditional Chinese Medicine

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