An observational study in Henoch-Schonlein Purpura Nephritis, sponsored by Liaoning University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-03-04.
Sponsored by Liaoning University of Traditional Chinese Medicine · Observational
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.
36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.
This study's enrollment of 600 is above the median of 300 across 17 observational studies indexed under IgA Vasculitis.
Browse IgA Vasculitis studies →Liaoning University of Traditional Chinese Medicine is the lead sponsor of 8 studies on the registry; none are open to participants now.
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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.
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Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formula
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.
Drug: angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressant
Qi-Ji Shen-Kang formula:15g of field thistle,10g of common edelweiss herb,10g of spreading hedyotis herb,10g ofYunnan manyleaf Paris rhizome,10g of hairyvein agrimonia herb,10g of the root bark of the tree peony,15g of root of red rooted salvia, and 15g ofmembranous mikvetch root.Zhu-Bai formula:10g of glabrous greenbrier rhizome,5g of Chinese atractylodes rhizome,10g of amur corktree bark,10g of common edelweiss her),10g of field thistle,10g of lalang grass rhizome,10g of garden burnet root,5g of longbract cattail pollen,5g of rehmanniae radix, and 5g of Chinese angelica root.Yu-Shen formula:15g of membranous mikvetch root,10g of heterophylla falsestarwort root,10g of field thistle,10g of cogongrass rhizome,10g of spreading hedyotis herb,10g of root of red rooted salvia,10g of fresh root of rehmannia,10g of Asian puccoon,10g of wormwoodlike motherwort herb,10g of common cockscomb inflorescence,10g of gordon euyale,10g of root bark of the tree peony, and 5g of licorice root.
prednisone at a dose of 1-1.5 mg/(kg·d) and Tripterygium wilfordii polyglycosidium at a dose of 1 mg/(kg·d). For each patient, the specific Western medicines used and their doses may be adjusted at the discretion of his or her physician, but the classes cannot be changed.
Urine protein
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.
Time frame: 2 weeks
24-hour urinary protein excretion
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.
Time frame: 2 weeks
Urine erythrocyte
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.
Time frame: 2 weeks
Creatinine clearance rate and Serum creatinine
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.
Time frame: 1 year
Number of patients with hormone therapy
Hormone utilized rate=Number of patients with hormone therapy/The total number of patients
Time frame: 3 months
Number of patients with immunosuppressant therapy
Immunosuppressant utilized rate=Number of patients with immunosuppressant therapy/The total number of patients
Time frame: 3 months
Plan to share: Yes — The Central Database of Clinical Evaluation of China Academy of Chinese Medicine Science
The record gives a start of Sep 2016, a primary completion of Mar 2019 and a completion of May 2020. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Liaoning University of Traditional Chinese Medicine