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

Henoch-Schönlein Purpura Nephritis Clinical Trial

Official title:

Demonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03591471
• Other study ID #: TCM for Children HSPN
• Secondary ID: 2013BAI02B07
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2014
• Est. completion date: December 2018

Study information

• Verified date: June 2018
• Source: Henan University of Traditional Chinese Medicine
• Contact: Ying Ding, professor
• Phone: +86-371-66221361
• Email: dingying3236[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Henoch-Schönlein Purpura Nephritis
• Nephritis
• Purpura
• Purpura, Schoenlein-Henoch

Intervention

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
• 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.
• 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.
• 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)
• 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.
• 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
• 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.
• 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.

Locations

Country	Name	City	State
China	Children's Hospital, The First Affiliated Hospital of HUTCM	Zhengzhou	Henan
China	The First Affiliated Hospital of Henan University of Traditional Chinese Medicine	Zhengzhou	Henan

Sponsors (6)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine	Affiliated Hospital of Yunnan University of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, Children's Hospital of Fudan University, Peking University First Hospital, Shanghai Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The white blood cell count(WBC) in the blood	There is a potential risk of abnormality in the blood system in terms of leukocyte counts after taking immunosuppressor or prednison. Leukocyte count should be recorded in total of 17 times during and after treatment through routine blood tests.	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
Other	The platelet count(PLT) in the blood	There is a potential risk of abnormality in the blood system in terms of platelet counts after taking immunosuppressor or prednison. Platelet count should be recorded in total of 17 times during and after treatment through routine blood tests.	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
Other	Glutamate alanine transferase(ALT) in the blood	There is a potential risk of dysfunction in liver after using any drug. As one of the indicators of liver damage,the test of ALT should be taken in total of 11 times during and after treatment through a liver function test by taking blood from vein.	Week0(before treatment),week1?week2?week4?week8?week12 of the treatment phase and week20?week28?week36?week44?week48 of the follow-up phase
Other	Glutamate aspartate transferase(AST) in the blood	There is a potential risk of dysfunction in liver after using any drug. As one of the indicators of liver damage,the test of AST should be taken in total of 11 times during and after treatment through a liver function test by taking blood from vein.	Week0(before treatment),week1?week2?week4?week8?week12 of the treatment phase and week20?week28?week36?week44?week48 of the follow-up phase
Other	Serum Creatinine(Scr)	There is a potential risk of dysfunction in kidney after using any drug. As an indicator of kidney damage,the test of Cr should be taken in total of 11 times during and after treatment through a kidney function test by taking blood from vein.	Week0(before treatment),week1?week2?week4?week8?week12 of the treatment phase and week20?week28?week36?week44?week48 of the follow-up phase
Other	Blood Urea Nitrogen(BUN)	There is a potential risk of dysfunction in kidney after using any drug. As an indicator of kidney damage,the test of BUN should be taken in total of 11 times during and after treatment through a kidney function test by taking blood from vein.	Week0(before treatment),week1?week2?week4?week8?week12 of the treatment phase and week20?week28?week36?week44?week48 of the follow-up phase
Primary	24-hour urinary protein quantity	24-hour urinary protein is the most important and direct indicators of therapeutic effect,so this clinical lab index should be reccord at every point during treatment and follow-up,17 times in total.	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	Urine red blood cells	Compared to 24-hour urinary protein,urine red blood cells count is a secondary indicator to reflect therapeutic effect because urine red blood cells recede more slowly than protein,this clinical lab index should also be reccorded at every point during treatment and follow-up,17 times in total.	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