Study on Children Henoch-Schönlein Purpura Nephritis With TCM Multistep Treatment

Summary

The purpose of this study is to determine the optimum dosage and application method of Glycosides Of Tripterygium Wilfordii Hook(GTW) for Henoch-Schönlein Purpura Nephritis(HSPN) in children, and develop into the normal treatment protocols for Henoch-Schönlein Purpura Nephritis in children.

Conditions

• Henoch-Schönlein Purpura Nephritis

Interventions

DRUG

Glycosides Of Tripterygium Wilfordii Hook(GTW)

For severe HSPN GTW is 2mg/kg/d for the first 2 weeks , continued with 1.5mg/kg/d (maximum to 90mg/d) for another 2 weeks; For light HSPN GTW is 1.5mg/kg/d(maximum to 90mg/d) for 4 weeks. Both the 2 types are continued with 1mg/kg/d of GTW for another 4 weeks . Besides,Sulfotanshinone Sodium Injection,Qingrezhixue graunles,Chinese herbs by syndrome differentiation are plused at the same time

DRUG

Sulfotanshinone Sodium Injection

Intravenous drip of Sulfotanshinone Sodium Injection with the dosage of 1mg/kg/d(maximum to 50mg), combined with 100-250ml 5% Glucose Solution (G.S) for 2 weeks in both the light and serious type of TCM group.

DRUG

Chinese herbs based on syndrome differentiation

For both the light and serious type of HSPN in TCM group,five traditional Chinese medicine patterns of syndrome are classified on the main pathogenesis "Blood Stasis": based on Qingre Zhixue granule,for wind-heat complicated with blood stasis, add Forsythia, Honeysuckle,;for blood-heat complicated with blood stasis,add Buffalo horn,Comfrey; for yin deficiency complicated with blood stasis, add Rhizoma anemarrhenae,Cortex phellodendri;for both qi and yin deficiency complicated with blood stasis,add Astragalus, Heterophylla;for damp-heat complicated with blood stasis,add Scutellaria baicalensis,Lalang Grass Rhizome.

DRUG

Prednisone Acetate Tablets

Prednisone Acetate Tablets are necessary for serious HSPN in controlled group,the initial dosage is 2mg/kg/d(maximum to 30mg,4 weeks),continue to reduce the dosage until discontinued（Reduce the dosage at the rate of 5mg every other day in 4-8 weeks，then reduce the dosage at the rate of 5-10mg per week in 8-12weeks）

DRUG

Benazepril Hydrochloride Tablets

In controlled group, Benazepril Hydrochloride Tablets are used for both the light and serious type with the dosage of 5-10mg/d(10mg/d for children with weight above 30kg) ,12 weeks in total.

DRUG

Low Molecular Weight Heparin Calcium Injection

In controlled group,Low Molecular Weight Heparin Calcium Injection are used for both the light and serious type with the dosage of 100u/kg/d by hypodermic injection for 2 weeks

DRUG

Dipyridamole Tab 25 MG

In controlled group,Dipyridamole Tab 25 MG are used for both the light and serious type of HSPN with the dosage of 3mg/kg/d ,3 times a day,12 weeks in total.

DRUG

Chinese medicine placebo

In controlled group,take a potential necessary for patients who come to the hospital of TCM to take traditional Chinese medicine in consideration, we add the traditional Chinese medicine placebo in controlled group.

Sponsors & Collaborators

• Peking University First Hospital

  collaborator OTHER

• Children's Hospital of Fudan University

  collaborator OTHER

• Shanghai Children's Hospital

  collaborator OTHER

• Chengdu University of Traditional Chinese Medicine

  collaborator OTHER

• Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

  collaborator UNKNOWN

• Henan University of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Ying Ding, professor · Henan University of Traditonal Chinese Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• China

Study Locations