To explore the mechanism of Jianpi Heluo Formula in treating IgA nephropathy from intestinal microflora -immune system-IgA nephropathy

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300070929

Enrollment

Unknown

Registered

2023-04-26

Start date

2023-04-30

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

IgA nephropathy

Interventions

Jianpi Heluo Formula group:Jianpi Heluo Formula + Basic treatment (ARB class antihypertensives)

Placebo group:Jianpi Heluo Formula Placebo+ Basic treatment (ARB class antihypertensives)

Healthy control group:none

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? A person with a diagnosis of IgA nephropathy by renal puncture biopsy. ?Chinese medicine evidence of spleen and kidney qi deficiency with dampness and heat. ? 24h urine protein quantification >0.5g,=2.0g. ? GFR>60ml/min/1.73m^2. ? Age 18-65 years. ?No antibiotics or micro-ecological regulators taken (or used) within 3 months prior to enrolment. ?Subjects agree and sign the informed consent form.

Exclusion criteria

Exclusion criteria: ?Secondary glomerular diseases such as diabetic nephropathy, purpura nephritis, lupus nephritis, hypertensive kidney damage, etc. ?Patients with more complex combined symptoms, including phlegm, stasis, cold, heat and toxicity, as well as obvious Yin and Yang deficiencies. ?Combined major systemic diseases of the cardiovascular, neurological and immune systems. ?Glucocorticoids and immunosuppressive drugs within the last 1 month. ?Allergic persons or persons with allergy to known components of the test drug. ?Pregnant or planning to become pregnant or breastfeeding women. ?Patients who have participated in clinical trials of other drugs within the last 1 month. ? Patients who have received the treatment of Jianpi Heluo Formula within the last 1 month. ?Psychiatric patients and persons with intellectual or speech impairment. ?Alcoholics and drug abusers and addicts.

Design outcomes

Primary

Measure	Time frame
24-hour urine protein quantification;Urine Red Blood Cell Count;	—

Secondary

Measure	Time frame
Renal function;	—

Countries

China

Contacts

Public ContactRen-Huan Yu

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

tezhongeyu@vip.sina.com+86 10 62835366

Outcome results

None listed

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