Clinical trial NCT02878018: Cohort Study on Traditional Chinese Medicine Diagnosis and Treatment of Children With Henoch-Schonlein Purpura Nephritis
Official title: Cohort Study on Traditional Chinese Medicine Diagnosis and Treatment of Children With Henoch-Schonlein Purpura Nephritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Henoch-Schonlein Purpura Nephritis
Keywords: Cohort Study
Children
Henoch-Schonlein Purpura Nephritis
Traditional Chinese Medicine
Lead sponsor: Liaoning University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: First Hospital of China Medical University
name: Shengjing Hospital
First posted: 2016-08-25
Enrollment: 600
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Urine protein
timeFrame: 2 weeks
measure: 24-hour urinary protein excretion
timeFrame: 2 weeks
measure: Urine erythrocyte
timeFrame: 2 weeks
measure: Creatinine clearance rate and Serum creatinine
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients with hormone therapy
timeFrame: 3 months
measure: Number of patients with immunosuppressant therapy
timeFrame: 3 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Zhang Jun
state: Liaoning
Study officials:
affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: jun zhang, master
role: STUDY_CHAIR
affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: jing lv, master
role: STUDY_DIRECTOR
affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: shaoqing zhang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: guanqi yang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: shuang pang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: binyu wu, master
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of China Medical University
name: yaoguo zhang, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang J, Lv J, Pang S, Bai X, Yuan F, Wu Y, Jiang H, Yang G, Zhang S. Chinese herbal medicine for the treatment of Henoch-Schonlein purpura nephritis in children: A prospective cohort study protocol. Medicine (Baltimore). 2018 Jun;97(24):e11064. doi: 10.1097/MD.0000000000011064.