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Efficacy of Integrated Chinese and Western Medicine Therapy (Shenyuan Granule combined with Basic Treatment of Western Medicine) for Chronic Kidney Disease (15=eGFR<45 ml/min/1.73m²)

Efficacy of Integrated Chinese and Western Medicine Therapy (Shenyuan Granule combined with Basic Treatment of Western Medicine) for Chronic Kidney Disease (15=eGFR<45 ml/min/1.73m²)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000557
Enrollment
Unknown
Registered
2025-03-20
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Chronic Kidney Disease

Interventions

Integrated Chinese and Western Medicine Group:Basic Treatment of Western Medicine + Shenyuan Granules
Basic Treatment of Western Medicine + Placebo Group:Basic Treatment of Western Medicine + Placebo

Sponsors

Affiliated Hospital of Hubei University of Chinese Medicine Hubei Provincial Hospital of Traditional Chinese Medicine.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Participants must meet the diagnostic criteria for CKD (15=eGFR<45 ml/min/1.73m²); (2) Participants with non-diabetic kidney disease; (3) 24-hour urinary total protein<3.5g; (4) Age between 18 and 70 years; (5) After basic antihypertensive treatment the value of the blood pressure=140/90 mmHg; (6) Participants must voluntarily partake in the research and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women; (2) Individuals allergic to any components of the study medication; (3) Presence of severe comorbidities such as heart brain liver lung or hematological system disorders; (4) Presence of tumors active pulmonary tuberculosis or other wasting diseases; (5) Hemoglobin levels< 80 g/L; (6) Individuals with mental disorders that impair cooperation; (7) Individuals who are participating in other clinical drug trials.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the change in eGFR slope over 24 weeks.;—

Secondary

MeasureTime frame
Patient reported outcome: symptom of "Fatigue"(RPFS-CV) ;Patient reported outcomes: symptoms of "poor appetite", "nausea", "vomit", "abdominal distension", "lumbago/cold pain in the waist", "ammonia taste in mouth"etc. (VAS);Compliance of patient(actual dose/schemed dose ×100%);Non-fatal cardiovascular and cerebrovascular events;The change in 24-hour urinary total protein from at 24-week to baseline;Composite endpoint events (Kidney survival analysis);Quality of life assessment (KDQOLTM-36);The change in serum albumin from at 24-week to baseline;The change in serum creatinine from at 24-week to baseline;—

Countries

China

Contacts

Public ContactWang Xiaoqin

Affiliated Hospital of Hubei University of Chinese Medicine Hubei Provincial Hospital of Traditional Chinese Medicine.

wangxiaoqin@hbhtcm.com18602751579

Outcome results

None listed

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