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

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Liaoning University of Traditional Chinese Medicine
• Collaborators: First Hospital of China Medical University; Shengjing Hospital
• Treatments: Adrenergic Agents; Adrenocorticotropic Hormone; Angiotensin-Converting Enzyme Inhibitors; beta-Endorphin; Cardiac Glycosides; Enzyme Inhibitors; Hormones; Immunosuppressive Agents; Melanocyte-Stimulating Hormones

Criteria

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.