Henoch-Schonlein Purpura Nephritis Clinical Trial
Official title:
Cohort Study on Traditional Chinese Medicine Diagnosis and Treatment of Children With Henoch-Schonlein Purpura Nephritis
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.
Background: Henoch-Schönlein purpura nephritis involves the renal impairment of
Henoch-Schönlein purpura and can easily relapse into life-threatening late nephropathy in
severe cases. Although there is a lack of validated evidence for its effectiveness,
traditional Chinese medicine is the most commonly used method in China to treat
Henoch-Schönlein purpura nephritis. We report the protocol of a prospective cohort trial
using traditional Chinese medicine to investigate the effectiveness, safety and advantages
for children with Henoch-Schönlein purpura nephritis.
Methods/Design: 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. Seven visits will be
scheduled for each participant with visits in week 0, week 2, week 4, week 6, week 8, week 10
and week 12. The primary outcomes include the remission rate and the recurrence rate. The
secondary outcomes include the urine erythrocyte effectiveness, the urine protein
effectiveness, the hormone usage rate, the immunosuppressant usage rate, and the incidence
rate of renal failure. Safety outcomes and any adverse reactions will be recorded during the
study.
Discussion: This study will determine whether the Chinese herbal formula is helpful for
treating Henoch-Schönlein purpura nephritis in children. The findings will provide a basis
for further confirmatory studies.
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