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

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ClinicalTrials.gov Identifier: NCT03591471
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborators:
Peking University First Hospital
Children's Hospital of Fudan University
Shanghai Children's Hospital
Chengdu University of Traditional Chinese Medicine
Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Henan University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Henoch-Schönlein Purpura Nephritis Drug: Glycosides Of Tripterygium Wilfordii Hook(GTW) Drug: Sulfotanshinone Sodium Injection Drug: Chinese herbs based on syndrome differentiation Drug: Prednisone Acetate Tablets Drug: Benazepril Hydrochloride Tablets Drug: Low Molecular Weight Heparin Calcium Injection Drug: Dipyridamole Tab 25 MG Drug: Chinese medicine placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Demonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation
Actual Study Start Date : September 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TCM multistep therapy

Light HSPN:1.Glycosides Of Tripterygium Wilfordii Hook(GTW): initial dosage is 1.5mg/kg/d(4 weeks),continued with 1mg/kg/d(8 weeks),12weeks in total. Severe HSPN:1.GTW:the initial dosage is 2mg/kg/d(2 weeks), continued with 1.5mg/kg/d(2 weeks) and 1mg/kg/d(8 weeks); 12weeks in total.

On the above base,Sulfotanshinone Sodium Injection(1mg/kg/d,2weeks) and Qingrezhixue granules(a nosocomial preparation) combined with Chinese herbs(12weeks) based on TCM syndrome differentiation are taken at the same time.

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.

Active Comparator: Routine medicine

Light HSPN:1.Lotensin: 5-10mg/d,12weeks; 2.Low Molecular Weight Heparin(LMWH):100u/kg,2weeks;3.Dipyridamole:3mg/kg/d,Tid,12weeks.4.Chinese medicine placebo,12weeks.

Severe HSPN:Add pednisone on the treatment of Light HSPN,and gradually reduce the dosage in 12 weeks,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: 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.
Other Name: Lotensin

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.
Other Name: Persantine

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.




Primary Outcome Measures :
  1. 24-hour urinary protein quantity [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. Urine red blood cells [ Time Frame: 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 ]
    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.


Other Outcome Measures:
  1. The white blood cell count(WBC) in the blood [ Time Frame: 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 ]
    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.

  2. The platelet count(PLT) in the blood [ Time Frame: 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 ]
    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.

  3. Glutamate alanine transferase(ALT) in the blood [ Time Frame: Week0(before treatment),week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase ]
    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.

  4. Glutamate aspartate transferase(AST) in the blood [ Time Frame: Week0(before treatment),week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase ]
    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.

  5. Serum Creatinine(Scr) [ Time Frame: Week0(before treatment),week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase ]
    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.

  6. Blood Urea Nitrogen(BUN) [ Time Frame: Week0(before treatment),week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase ]
    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.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591471


Contacts
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Contact: Ying Ding, professor +86-371-66221361 dingying3236@sina.com
Contact: Guizhen Zheng, Lecturer +86-371-65962457 zhengguizhen@126.com

Locations
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China, Henan
Children's Hospital, The First Affiliated Hospital of HUTCM Recruiting
Zhengzhou, Henan, China, 450000
Contact: Ying Ding, Director    +86-13503840642    dingying3236@sina.com   
Contact: Xia Zhang, secretary    +86-13838276039    zhangxia_125@163.com   
Principal Investigator: Ying Ding, Director         
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine Recruiting
Zhengzhou, Henan, China, 450000
Contact: Ying Ding, MD    +86-371-66221361    dingying3236@sina.com   
Contact: Xia zhang, MD    +86-371-13213210370    ardar123@sina.com   
Principal Investigator: Jiansheng Li, MD         
Sponsors and Collaborators
Henan University of Traditional Chinese Medicine
Peking University First Hospital
Children's Hospital of Fudan University
Shanghai Children's Hospital
Chengdu University of Traditional Chinese Medicine
Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Ying Ding, professor Henan University of Traditonal Chinese Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03591471     History of Changes
Other Study ID Numbers: TCM for Children HSPN
2013BAI02B07 ( Other Grant/Funding Number: National Science & Technology Support )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We allow all the data to be made public once the trial finished
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Our data will become availiable from January,2019 and for 10 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henan University of Traditional Chinese Medicine:
Children,
Henoch-Schönlein Purpura Nephritis
Integrated and Stepped Treatment in TCM
Additional relevant MeSH terms:
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Nephritis
Purpura, Schoenlein-Henoch
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Immune Complex Diseases
Hypersensitivity
Immune System Diseases
Prednisone
Cardiac Glycosides
Benazepril
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Dipyridamole
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs