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Randomized controlled clinical study on treating type 2 diabetes mellitus with nonalcoholic fatty liver with Jiangtang Xiaozhi prescription

Randomized controlled clinical study on treating type 2 diabetes mellitus with nonalcoholic fatty liver with Jiangtang Xiaozhi prescription

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000294
Enrollment
Unknown
Registered
2024-08-24
Start date
2024-08-28
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Type 2 diabetes mellitus with nonalcoholic fatty liver disease

Interventions

experimental group:Oral Jiangtang Xiaozhi granules
control group 1 bag twice a day :Oral placebo 1 bag twice a day

Sponsors

Xi Yuan Hospital of Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.It meets the diagnostic criteria of Western medicine for T2DM combined with NAFLD and has a wide spectrum of NAFLD diseases including non-alcoholic simple hepatic steatosis (NAFL) non-alcoholic steatohepatitis (NASH) NASH-related cirrhosis and hepatocellular carcinoma (HCC). In this study patients with non-alcoholic simple fatty liver degeneration (NAFL) at specific stages of NAFLD were included patients with liver B-ultrasound consistent with image diagnosis of fatty liver and patients with TCM syndrome differentiation of Qi deficiency and phlegm stasis. 2. Age 18-65 years old gender is not limited. 3. Subjects are informed and sign informed consent voluntarily. 4. Blood glucose level: HBA1c <8.5% FBG<10mmol/l PBG<13mmol/l.

Exclusion criteria

Exclusion criteria: 1. Significantly abnormal liver function (ALT or AST> 2 times the upper limit of normal); In the past 1 month the use of other liver protection and enzyme lowering drugs affected the efficacy evaluation. 2. Liver fibrosis cirrhosis solid liver tumors and focal fatty liver can not exclude regenerated nodules or metastases; It can lead to fatty liver and other liver diseases which are Autoimmune liver disease and drug-induced liver injury (DILI). 3. Diabetes patients with GLP-1SGLT-2 TZD hypoglycemic drugs. 4. Non-stable doses of statins or Bates in the 3 months prior to randomization. 5. Acute complications of diabetes occurred in the past three months. 6. Patients with serious organic diseases of the heart lung kidney and other important organs or serious diseases of the hematopoietic system tumors serious cardiovascular and cerebrovascular diseases and mental disorders. 7. Patients with abnormal renal function. 8. Women who are pregnant or trying to become pregnant breastfeeding women. 9. Patients with drug allergy in this study. 10. The examinations and tests involved in this study could not be performed. Those who cannot cooperate or are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Liver B ultrasonic sound attenuation coefficient;

Secondary

MeasureTime frame
Blood glucose;Liver function;Body mass index;insulin;Glycosylated hemoglobin;Insulin resistance index;Blood lipid;TNF-a;hs-CRP;waistline;

Countries

China

Contacts

Public ContactChen Zhuhong

Xi Yuan Hospital of Academy of Chinese Medical Sciences

13264214919@163.com13264214919

Outcome results

None listed

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