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

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.

Conditions

• Henoch-Schonlein Purpura Nephritis

Interventions

DRUG

Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formula

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.

DRUG

angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressant

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.

Sponsors & Collaborators

• First Hospital of China Medical University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Liaoning University of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• jun zhang, master · Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

• jing lv, master · Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

• shaoqing zhang, doctor · Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

• guanqi yang, doctor · Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

• shuang pang, doctor · Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

• binyu wu, master · Shengjing Hospital

• yaoguo zhang, master · First Hospital of China Medical University

Eligibility

Min Age

5 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2019-03-31

Completion

2020-05-31

Countries

• China

Study Locations