Study on Children Henoch-Schönlein Purpura Nephritis With TCM Multistep Treatment
- Conditions
- Henoch-Schönlein Purpura Nephritis
- Interventions
- Drug: Chinese herbs based on syndrome differentiationDrug: Low Molecular Weight Heparin Calcium InjectionDrug: Chinese medicine placebo
- Registration Number
- NCT03591471
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- Clinical diagnosis of Henoch-Schönlein Purpura Nephritis Disease
- Age form 2-18 years old
- Disease onset within 2 months
- Nephritis not causing by HSPN
- Being alergic to the medicine in the treatment
- No compliance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TCM multistep therapy Sulfotanshinone Sodium Injection 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. TCM multistep therapy Chinese herbs based on syndrome differentiation 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. Routine medicine Prednisone Acetate Tablets 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） Routine medicine Benazepril Hydrochloride Tablets 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） Routine medicine Low Molecular Weight Heparin Calcium Injection 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） Routine medicine Dipyridamole Tab 25 MG 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） Routine medicine Chinese medicine placebo 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） TCM multistep therapy Glycosides Of Tripterygium Wilfordii Hook(GTW) 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.
- Primary Outcome Measures
Name Time Method 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 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
Name Time Method 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 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.
Trial Locations
- Locations (2)
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, China