Cohort Study on Traditional Chinese Medicine Diagnosis and Treatment of Children With Henoch-Schonlein Purpura Nephritis
- Conditions
- Henoch-Schonlein Purpura Nephritis
- Interventions
- Drug: Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formula
- Registration Number
- NCT02878018
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TCM intervention Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formula Participants with HSPN of the Heat-Toxin type will take the Qi-Ji Shen-Kang formula. HSPN patients of the Wet-Heat type will take the Zhu-Bai formula. Those of Qi-Deficiency with Blood-Stasis type will take the Yu-Shen formula. WM conventional intervention angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressant The WM conventional intervention, recommended by the Chinese Medical Association's (CMA) Scientific Statement, includes angiotensin-converting enzyme (ACE) inhibitor, adrenergic receptor binder (ARB), adrenal cortical hormone, Tripterygium wilfordii polyglycosidium and an immunosuppressant.
- Primary Outcome Measures
Name Time Method Urine erythrocyte 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.Urine protein 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.Creatinine clearance rate and Serum creatinine 1 year Diagnostic criteria of chronic renal failure:
1. Creatinine clearance rate\<80ml/min;
2. Serum creatinine\>133μmol/L;
3. The patient who have a history of chronic kidney diseases or systemic diseases involving kidney.24-hour urinary protein excretion 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.
- Secondary Outcome Measures
Name Time Method Number of patients with hormone therapy 3 months Hormone utilized rate=Number of patients with hormone therapy/The total number of patients
Number of patients with immunosuppressant therapy 3 months Immunosuppressant utilized rate=Number of patients with immunosuppressant therapy/The total number of patients
Trial Locations
- Locations (1)
Zhang Jun
🇨🇳Shenyang, Liaoning, China