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Effect of Qingshen Granules on renal outcome in chronic kidney disease stage 3-4 patients with damp-heat syndrome and safety of Qingshen granules:a real-world multicenter, prospective cohort study

Effect of Qingshen Granules on renal outcome in chronic kidney disease stage 3-4 patients with damp-heat syndrome and safety of Qingshen granules:a real-world multicenter, prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005173
Enrollment
Unknown
Registered
2021-08-15
Start date
2021-08-16
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

chronic kidney disease stage 3-4 patients with damp-heat syndrome

Interventions

Rape exposure group (oral Qingshen granules > 18 months):Qingshen granules
Weak exposure group (oral Qingshen granules < 6 months):Qingshen granules
Medium exposure group (oral Qingshen granules for 6 ~ 18 months):Qingshen granules

Sponsors

the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years, male or female; 2. Meet the diagnostic criteria of CKD stage 3a-4, as well as the syndrome differentiation criteria of TCM damp-heat syndrome; 3. Blood pressure =80g/L, infection under control, and stable condition for more than 2 weeks at the time of enrollment; 4. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients; 2. Unable to cooperate, such as mental patients; 3. Combined with serious primary diseases such as active malignant tumor, decompensated liver cirrhosis or hematopoietic system; 4. Patients with infectious diseases; 5. There is acute urinary tract obstructive disease, requiring surgical treatment; 6. Severe arrhythmia, severe heart failure, NYHA class III and above (evidence of New York Heart Association class III and IV), or myocardial infarction or cerebrovascular events within 3 months before enrollment; 7. Are using corticosteroids, non-steroidal anti-inflammatory drugs or immunosuppressants; 8. Those undergoing emergency hemodialysis; 9. Those who have undergone kidney transplantation and total or partial parathyroidectomy; 10. Those who are known to be allergic to or intolerable to a certain drug in this study; patients who are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Blood creatinine doubled;First dialysis;

Secondary

MeasureTime frame
Mineral and bone metabolism indexes;Cardiovascular events;Detection of vascular calcification;

Countries

China

Contacts

Public ContactWang Yiping

the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

wypwyp54@aliyun.com+86 13075580986

Outcome results

None listed

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