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A multicenter, prospective, randomized controlled clinical study of Yishenhuashui granule in the treatment of IgAN

A multicenter, prospective, randomized controlled clinical study of Yishenhuashui Granule in the treatment of IgAN

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065760
Enrollment
Unknown
Registered
2022-11-14
Start date
2022-11-15
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

IgA nephropathy (lgAN)

Interventions

Treatment group:Conventional treatment + Yishenhuashi Granule
Control group:Conventional treatment

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers: (1) Healthy adults, aged between 18 and 75 years, no gender or ethnicity limit; (2) Informed consent, and sign the informed consent. 2. Patients with IgAN: (1) Aged 18-75 years, no gender or ethnicity limit; (2) Primary IgAN was confirmed by renal biopsy and clinical examination; (3) TCM syndrome differentiation of spleen deficiency and dampness; (4) CKD1-2 stage before treatment: eGFR (EPI formula) >=60ml/min; (5) Before treatment, 24 hours urinary protein quantity <=3.0g; (6) Informed consent, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have received glucocorticoids, immunosuppressants, cytotoxic drugs and other treatments within the last 6 months; 2. Patients with acute or acute nephritis; 3. Complicated with life-threatening complications such as severe infection; 4. Patients with active hepatitis B and transaminase abnormalities in continuous liver function test; 5. Patients with malignant tumors or a history of malignant tumors, HIV infection, mental illness, acute central nervous system diseases, severe gastrointestinal diseases, and hormone use prohibited; 6. Patients with abnormal glucose metabolism and significantly elevated blood glucose (including impaired fasting blood glucose and abnormal glucose tolerance); 7. Pregnant or lactating patients; 8. Being enrolled in other clinical trials; 9. Patients with serious diseases and dysfunction of other organs.

Design outcomes

Primary

MeasureTime frame
24-hour urinary protein quantitation;

Secondary

MeasureTime frame
Estimate glomerular filtration rate (eGFR);Urine red blood cell count;TCM syndrome curative effect;

Countries

China

Contacts

Public ContactZhong Yifei

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

sh_zhongyifei@shutcm.edu.cn+86 13816006668

Outcome results

None listed

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