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Clinical study on Jianpi Zhishui Granules treating gouty nephropathy (spleen deficiency and dampness resistance type)

Clinical study on Jianpi Zhishui Granules treating gouty nephropathy (spleen deficiency and dampness resistance type)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070861
Enrollment
Unknown
Registered
2023-04-25
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

gouty nephropathy

Interventions

Experimental group:Oral administration of febuxostat tablets and Jianpi Xiaoshi granules
Control group:Oral febuxostat tablets

Sponsors

The First Affiliated Hospital of Yunnan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Those who meet the diagnostic criteria of gouty nephropathy in Western medicine and syndrome differentiation criteria of spleen deficiency and dampness in Chinese medicine; (2) The age range was 18 to 70 years old, and the gender was not limited; (3) Informed consent and voluntary participation in the treatment; (4) The serum creatinine value of patients with abnormal renal function was more than 104umol/L, but less than 177umol/L (renal function compensation period).

Exclusion criteria

Exclusion criteria: (1) Those who were in the acute phase of gouty arthritis at the time of screening; (2) Patients with elevated blood uric acid due to previous history of renal disease or renal insufficiency; (3) Patients with elevated blood uric acid caused by secondary nephropathy caused by hematological system, severe psoriasis, widespread spread of malignant tumors, or damage caused by radiotherapy and chemotherapy; (4) Suffering from serious diseases of other organs or systems, such as cardiovascular and cerebrovascular diseases, lung and liver diseases; Or suffers from a serious disease that affects their survival, such as AIDS; (5) Allergic constitution, drug allergy involved in this study; (6) Special groups: women during pregnancy or breastfeeding, or those suffering from mental diseases; (7) Additional lesions or conditions that may complicate enrollment, as determined by the investigator; (8) A history of alcohol or drug abuse; (9) Patients who are participating in clinical trials of other drugs.

Design outcomes

Primary

MeasureTime frame
Estimate glomerular filtration rate;Degree of improvement in serum creatinine (SCr);liver function;

Secondary

MeasureTime frame
routine urine test;Blood uric acid compliance rate;Number of acute arthritis episodes during treatment;

Countries

China

Contacts

Public ContactLi Zhaofu

Yunnan University of Traditional Chinese Medicine

lzf0817@126.com+86 13187442840

Outcome results

None listed

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