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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational [Patient Registry]

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

Brief Summary: Henoch-Schonlein purpura nephritis(HSPN) is one of the most common secondary glomerulonephritis in children.This is an important chronic disease endangering children's health.The main drugs in clinic are glucocorticoid,immunosuppressants and anticoagulation.Subject group concluded a series of prescriptions to treat children with purpura nephritis:Qijishenkang lotion,Zhubai lotion,More Kidney lotion.Prospective cohort study of clinical research methods are adopted.To develop clinical diagnosis and treatment scheme which can be widely used to treat children with purpura nephritis (Heat Toxin Injuring Collaterals Type,Damp Heat Injuring Collaterals Type,Qi Deficiency and Blood Stasis Syndrome).

Detailed Summary:
Sponsor: Liaoning University of Traditional Chinese Medicine

Current Primary Outcome:

  • Urine protein [ Time Frame: 2 weeks ]
    1. Recovery:Urine protein(-).
    2. Marked effect:Urine protein reduces by 2'+'.
    3. Effective：Urine protein reduces by 1'+'.
    4. Ineffective：Urine protein has no changes.
  • 24-hour urinary protein excretion [ Time Frame: 2 weeks ]
    1. Recovery:24-hour urinary protein excretion is normal.
    2. Marked effect:24-hour urinary protein excretion reduction is larger than 50%.
    3. Effective：24-hour urinary protein excretion reduction is smaller than 50%.
    4. Ineffective：24-hour urinary protein excretion has no changes.
  • Urine erythrocyte [ Time Frame: 2 weeks ]
    1. Recovery:Urine erythrocyte is normal.
    2. Marked effect:Urine erythrocyte reduction is larger than 50%.
    3. Effective:Urine erythrocyte reduction is smaller than 50%.
    4. Ineffective；Urine erythrocyte has no changes.
  • Creatinine clearance rate and Serum creatinine [ Time Frame: 1 year ]

    Diagnostic criteria of chronic

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Number of patients with hormone therapy [ Time Frame: 3 months ]
      Hormone utilized rate=Number of patients with hormone therapy/The total number of patients
    • Number of patients with immunosuppressant therapy [ Time Frame: 3 months ]
      Immunosuppressant utilized rate=Number of patients with immunosuppressant therapy/The total number of patients


    Original Secondary Outcome: Same as current

    Information By: Liaoning University of Traditional Chinese Medicine

    Dates:
    Date Received: August 17, 2016
    Date Started: September 2016
    Date Completion: May 2020
    Last Updated: November 23, 2016
    Last Verified: November 2016