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

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

Sponsors

Lead Sponsor: Henan University of Traditional Chinese Medicine

Collaborator: 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

Source 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.

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.

Overall Status Unknown status
Start Date September 2014
Completion Date December 2018
Primary Completion Date December 2018
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
24-hour urinary protein quantity 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 Outcome
Measure Time Frame
Urine red blood cells 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
Enrollment 500
Condition
Intervention

Intervention Type: Drug

Intervention Name: Glycosides Of Tripterygium Wilfordii Hook(GTW)

Description: 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

Arm Group Label: TCM multistep therapy

Intervention Type: Drug

Intervention Name: Sulfotanshinone Sodium Injection

Description: 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.

Arm Group Label: TCM multistep therapy

Intervention Type: Drug

Intervention Name: Chinese herbs based on syndrome differentiation

Description: 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.

Arm Group Label: TCM multistep therapy

Intervention Type: Drug

Intervention Name: Prednisone Acetate Tablets

Description: 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)

Arm Group Label: Routine medicine

Intervention Type: Drug

Intervention Name: Benazepril Hydrochloride Tablets

Description: 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.

Arm Group Label: Routine medicine

Other Name: Lotensin

Intervention Type: Drug

Intervention Name: Low Molecular Weight Heparin Calcium Injection

Description: 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

Arm Group Label: Routine medicine

Intervention Type: Drug

Intervention Name: Dipyridamole Tab 25 MG

Description: 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.

Arm Group Label: Routine medicine

Other Name: Persantine

Intervention Type: Drug

Intervention Name: Chinese medicine placebo

Description: 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.

Arm Group Label: Routine medicine

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

Gender: All

Minimum Age: 2 Years

Maximum Age: 18 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ying Ding, professor Principal Investigator Henan University of Traditonal Chinese Medicine
Overall Contact

Last Name: Ying Ding, professor

Phone: +86-371-66221361

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
Children's Hospital, The First Affiliated Hospital of HUTCM | Zhengzhou, Henan, 450000, China Recruiting Ying Ding, Director +86-13503840642 [email protected] Ying Ding, Director Principal Investigator
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | Zhengzhou, Henan, 450000, China Recruiting Ying Ding, MD +86-371-66221361 [email protected] Jiansheng Li, MD Principal Investigator
Location Countries

China

Verification Date

June 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: TCM multistep therapy

Type: Experimental

Description: 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.

Label: Routine medicine

Type: Active Comparator

Description: 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)

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov