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.

Inclusion criteria

1. 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.
2. Age: 5 to 18 years old (including 5 and 18 year-olds).
3. The clinical classification of HSPN includes isolated hematuria, insolated proteinuria, hematuria with proteinuria, and acute glomerulonephritis.
4. The ability to provide detailed connection and complete a followup.
5. The ability to understand and sign a written informed consent.

Exclusion criteria

1. HSPN with renal insufficiency.
2. A clinical classification of HSPN that includes nephritic syndrome, rapidly progressive glomerulonephritis and chronic glomerulonephritis.
3. Suffering from serious complications, such as respiratory, digestive, hematological or liver diseases.
4. Tumor, infectious diseases, or mental disorders.
5. Allergic to TCM use.
6. No prescribed medication, poor compliance, or incomplete data affecting the efficacy and safety of these judgments.
7. A history of another clinical trial in the previous 2 weeks.
8. No consent form signed.

Children with purpura nephritis who are treated in Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shengjing Hospital of China Medical University and The First Hospital of China Medical University will be regarded as the objects of study.

The Central Database of Clinical Evaluation of China Academy of Chinese Medicine Science