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Cohort Study on Traditional Chinese Medicine Diagnosis and Treatment of Children With Henoch-Schonlein Purpura Nephritis

China600 participantsStarted 2016-09

Plain-language summary

Henoch-Schonlein purpura nephritis(HSPN) is one of the most common secondary glomerulonephritis in children. A large, prospective, multicenter cohort study is being conducted in three institutions. Eligible Henoch-Schönlein purpura nephritis children will be classified as the experimental group (n=300) and the control group (n=300) based on the interventions they receive. Patients taking Chinese herbal formula will be in the experimental group, and those taking Western medicine will be in the control group. The entire study will last 60 weeks, including a 12-week observation period and a followup at 12 months.

Who can participate

Age range5 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A diagnosis of HSPN as well as three major constitution types (Heat-Toxin, Wet-Heat, Qi-Deficiency with Blood-Stasis) according to WM and TCM.
✓. Age: 5 to 18 years old (including 5 and 18 year-olds).
✓. The clinical classification of HSPN includes isolated hematuria, insolated proteinuria, hematuria with proteinuria, and acute glomerulonephritis.
✓. The ability to provide detailed connection and complete a followup.
✓. The ability to understand and sign a written informed consent.

Exclusion criteria

✕. HSPN with renal insufficiency.
✕. A clinical classification of HSPN that includes nephritic syndrome, rapidly progressive glomerulonephritis and chronic glomerulonephritis.
✕. Suffering from serious complications, such as respiratory, digestive, hematological or liver diseases.
✕. Tumor, infectious diseases, or mental disorders.

What they're measuring

Urine protein

Timeframe: 2 weeks

24-hour urinary protein excretion

Timeframe: 2 weeks

Urine erythrocyte

Timeframe: 2 weeks

Creatinine clearance rate and Serum creatinine

Timeframe: 1 year

Trial details

NCT IDNCT02878018

SponsorLiaoning University of Traditional Chinese Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-03

View on ClinicalTrials.gov More Henoch-Schonlein Purpura Nephritis trials

Plain-language summary

Who can participate

Age range5 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A diagnosis of HSPN as well as three major constitution types (Heat-Toxin, Wet-Heat, Qi-Deficiency with Blood-Stasis) according to WM and TCM.
✓. Age: 5 to 18 years old (including 5 and 18 year-olds).
✓. The clinical classification of HSPN includes isolated hematuria, insolated proteinuria, hematuria with proteinuria, and acute glomerulonephritis.
✓. The ability to provide detailed connection and complete a followup.
✓. The ability to understand and sign a written informed consent.

Exclusion criteria

✕. HSPN with renal insufficiency.
✕. A clinical classification of HSPN that includes nephritic syndrome, rapidly progressive glomerulonephritis and chronic glomerulonephritis.
✕. Suffering from serious complications, such as respiratory, digestive, hematological or liver diseases.
✕. Tumor, infectious diseases, or mental disorders.