Clinical trial NCT03591471: Study on Children Henoch-Schönlein Purpura Nephritis With TCM Multistep Treatment
Official title: Demonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Henoch-Schönlein Purpura Nephritis
Keywords: Children，
Henoch-Schönlein Purpura Nephritis
Integrated and Stepped Treatment in TCM
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Children's Hospital of Fudan University
name: Shanghai Children's Hospital
name: Chengdu University of Traditional Chinese Medicine
name: Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
First posted: 2018-07-19
Enrollment: 500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Based on Chinese Eleventh Five-year Plan for Science and Technology Program, this study follows a large-sample multicenter centerrandom open-label controlled perspective method, enrolls HSPN children with hematuria associated with proteinuria and isolated proteinuria from 2 to 18 years of age, classifys five traditional Chinese medicine patterns of syndrome: wind-heat complicated with blood stasis, blood-heat complicated with blood stasis, yin deficiency complicated with blood stasis, both qi and yin deficiency complicated with blood stasis,damp-heat complicated with blood stasis. For TCM group,according to the severity of HSPN, stepped treatment should be taken. The initial dosage of GTW for severe HSPN is 2mg/kg/d, continued with 1.5mg/kg/d and 1mg/kg/d; The initial dosage of GTW for light HSPN is 1.5mg/kg/d, continued with 1mg/kg/d. On the above base, the comprehensive treatment are taken combined with TCM syndrome differentiation, medicated with Sulfotanshinone Sodium Injection.For controlled group,the treatment for severe HSPN is prednisone combined with heparin plus lotensin and dipyridamole tablets;for light HSPN is heparin plus lotensin and dipyridamole tablets.12 weeks after treatment, the third-party statistics evaluate the efficacy and effect,and a follow-up lasting 36 weeks will go on.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Henoch-Schönlein Purpura Nephritis Disease
* Age form 2-18 years old
* Disease onset within 2 months

Exclusion Criteria:

* Nephritis not causing by HSPN
* Being alergic to the medicine in the treatment
* No compliance

Primary outcomes:
measure: 24-hour urinary protein quantity
timeFrame: Changes in the quantity of urinary protein at week 1、week2、week 4、week6、week8、week10 and week12 of the treatment phase and at week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase compared with baseline
Secondary outcomes:
measure: Urine red blood cells
timeFrame: Changes in the quantity of urinary protein at week 1、week2、week 4、week6、week8、week10 and week12 of the treatment phase and at week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase compared with baseline
Other outcomes:
measure: The white blood cell count(WBC) in the blood
timeFrame: Week0(before treatment),week1、week2、week4、week6、week8、week10 and week12 of the treatment phase and week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase
measure: The platelet count(PLT) in the blood
timeFrame: Week0(before treatment),week1、week2、week4、week6、week8、week10 and week12 of the treatment phase and week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase
measure: Glutamate alanine transferase(ALT) in the blood
timeFrame: Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase
measure: Glutamate aspartate transferase(AST) in the blood
timeFrame: Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase
measure: Serum Creatinine(Scr)
timeFrame: Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase
measure: Blood Urea Nitrogen(BUN)
timeFrame: Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase
Locations:
city: Zhengzhou
country: China
facility: Children's Hospital, The First Affiliated Hospital of HUTCM
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
affiliation: Henan University of Traditonal Chinese Medicine
name: Ying Ding, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ding Y, Zhang X, Ren X, Zhai W, He L, Liu J, Yao C, Han S, Wang L. Traditional Chinese medicine versus regular therapy in Henoch-Schonlein purpura nephritis in children: study protocol for a randomized controlled trial. Trials. 2019 Aug 29;20(1):538. doi: 10.1186/s13063-019-3484-3.