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Efficacy and safety of the method of eliminating turbidity and dredging channels in the treatment of gout combined with metabolic fatty liver (syndrome of internal retention of damp-turbidity): a randomized parallel double-blind controlled clinical trial

Efficacy and safety of the method of eliminating turbidity and dredging channels in the treatment of gout combined with metabolic fatty liver (syndrome of internal retention of damp-turbidity): a randomized parallel double-blind controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000245
Enrollment
Unknown
Registered
2024-08-16
Start date
2024-01-31
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

Gout combined with metabolic fatty liver disease

Interventions

treatment group:Eliminating turbidity and dredging channels method granules, one pack per time, BID+ febuxostat tablets, oral, 20-40mg per dose, qd +healthy lifestyle management.
Control group:Simulant of Eliminating turbidity and dredging channels method granules, one pack per time, BID+ febuxostat tablets, oral, 20-40mg per dose, qd +healthy lifestyle management.

Sponsors

The First Teaching Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of Western medicine and traditional Chinese medicine syndromes for this disease can be included in treatment; 2. The patient did not receive any other medication or treatment measures within two weeks prior to entering the clinical trial; 3. Patients who have not received standardized treatments such as strict lifestyle interventions in the past; 4.Aged 18 to 70 years 5. Patients who voluntarily participate and have signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the inclusion criteria; 2. Patients with specific liver diseases such as alcoholic liver disease (ALD), viral hepatitis, autoimmune liver disease, hepatolenticular degeneration, etc., can lead to fatty liver; 3. Medications (such as tamoxifen, amiodarone, sodium valproate, methotrexate, glucocorticoids, etc.), total parenteral nutrition, inflammatory bowel disease, hypothyroidism, Cushing's syndrome, etc ß Fatty liver caused by lipoprotein deficiency and some syndromes related to insulin resistance (lipoatrophic diabetes, Mauriac syndrome); 4. Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, malignant tumors, other serious comorbidities, or mental illness; 5. The patient has diabetes or is receiving anti diabetes drugs; 6. Patients who are using NAFLD treatment drugs (including Chinese herbal decoction, traditional Chinese patent medicines and simple preparations and chemical drugs) and ALT = 5 times the standard value; 7. Known allergies to the components of the research product or patients with allergic constitution; 8. Pregnant and lactating women, as well as women who refuse to maintain the contraceptive measures recognized by the researchers throughout the entire study process and are at risk of pregnancy; 9. Those who have participated in other clinical trials in the past three months or are currently participating in other clinical trials; 10. Those who are unable to follow medical advice for therapeutic lifestyle changes; 11. Suspect having a history of drug abuse or having other patients who do not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
Controlled attenuation parameter (CAP) value of liver fat;Uric acid decrease before and after treatment;

Secondary

MeasureTime frame
Traditional Chinese Medicine syndrome score;Patient satisfaction score;Acute attacks of gout during treatment;Laboratory indicators;Changes in liver ultrasound imaging before and after treatment;

Countries

China

Contacts

Public ContactLiu Wei

First Teaching Hospital of Tianjin University of TCM

fengshiliuwei@163.com+86 135 1616 1000

Outcome results

None listed

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