A Phase IIa Study to Evaluate the Effect of Yishen Huazhuo Granules in Patients With Membranous Nephropathy (MN)

The Effect and Safety of Yishen Huazhuo Granules in the Treatment of Membranous Nephropathy (MN) With TCM Sign Syndrome of Spleen Kidney qi Deficiency With Blood Stasis: A Randomized, Multi-Center, Double-Blind, Parallel Controlled Phase IIa Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IID-17013318

Enrollment

Unknown

Registered

2017-11-09

Start date

2019-07-31

Completion date

Unknown

Last updated

2023-04-12

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

Conditions

Membranous Nephropathy (MN)

Interventions

high dose group:Drug: Yishen Huazhuo Granules high dose 10g per packaging bag, 2 bags every time after meal, and twice a day, follow-up 24 weeks.

low dose group:Drug: Yishen Huazhuo Granules low dose 10g per packaging bag, 1 bag of normal dosage and 1 bag of ultra-low-dosage every time after meal, twice a day, follow-up 24 weeks.

ultra-low-dose group:Drug: Yishen Huazhuo Granules ultra-low-dose 10g per packaging bag, which major component is excipient, only contains one tenth of normal active ingredients. 2 bags of ultra-low-d

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. One of the following examinations was met: (1) previous renal puncture examination identified pathological type is membrane nephropathy (MN), pathological stage is stage I~IV according to Ehrenreich-Churg stage; (2) no renal puncture examination, positive anti-PLA2-R antibody and patients with normal renal function (normal creatinine results); 2. Urinary proteinuria between 1g to 3g measured from a 24-hour urine protein collection; 3. Glomerular filtration rate (eGFR): (1) The previous renal biopsy has confirmed that the pathological type is membranous nephropathy (MN)Of patients, eGFR >= 45 ml/min/1.73m2 (eGFR, using CKD-EPI formula); (2) Patients with positive anti-PLA2-R antibodies without renal biopsy, eGFR >= 60 ml/min/1.73m2; 4. The patients to be diagnosed as TCM sign syndrome of spleen kidney qi deficiency with blood stasis; 5. Males and females between the ages of 18 and 80 years; 6. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Plasma albumin 150/90 mmHg; 3. Patients with hepatic insufficiency, AST and/or ALT > 1.5 upper limits of normal (ULN); 4. Blood potassium > 5.5mol/l 5. Patients with malignant tumor, central nervous system disorder, diabetes, severe gastrointestinal disease, cardiovascular disease, other serious functional disorder, psychosis, or patients who can not coordinate; 6. Patients have received hormonotherapy, immunosuppressant, or cytotoxic drugs treatment within last 3 months before enrollment; 7. Pregnancy, lactation, inadequate contraceptives, or patients who plan to be pregnant in next 6 months; 8. Allergic to investigational drug; 9. Patients have participated in other clinical trials in past 30 days before enrollment; 10. Condition unstable to receive the treatment.

Design outcomes

Primary

Measure	Time frame
Change from baseline in 24-hour urine protein. [ Time frame: baseline up to 24 weeks];	—

Secondary

Measure	Time frame
Plasma albumin;Change from baseline in eGFR (CKD-EPI formula) [ Time frame: baseline up to 24 weeks];Change of TCM Syndrome scores;	—

Countries

China

Contacts

Public ContactXusheng Liu

Guangdong Provincial Hospital of Chinese Medicine

liuxu801@126.com+86 13503078703

Outcome results

None listed

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