NCT01104428

Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Liaoning University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Due to high incidence of renal damage by Hench-schonlein Purpura(HSP) is the key to affect prognosis, this project moves the research emphasis forward in line with the idea of "prevention of progress of disease", Which concerns on Traditional Chinese Medicine(TCM) clinical research scheme evaluation of HSP, evaluates the renal damage and disease recurrence as the end event, and comes to the evaluation through the comparative study that the vantage point of the scheme of syndrome differentiation and treatment in detoxification, cooling blood and removing blood stasis to the conventional treatments can reduce kidney damage and recurrence rate.

Detailed description

Target：Optimize the TCM scheme of syndrome differentiation and treatment of HSP in line with the idea of blood- Cooling - Toxin - Removing - Stasis - Dispersing under the path of combination between disease differentiation and syndrome differentiation, and regards reducing the rate of the recurrence of HSP and kidney damage as the end point of evaluation indexes, to evaluate the clinical efficacy of the scheme scientifically. Main research contents: Retrospective case investigation, analysis and research on literature, research on clinical assessment of the scheme of syndrome differentiation and treatment. Methods：With a series of compounds as the main interference factors, choosing the sample estimation of superiority design and adopting the test methods of randomized, double-blind, placebo-controlled to carry out the research of multicenter clinical efficacy evaluation. It summarizes the advantages and rules of syndrome differentiation and treatment in TCM by means of the comparative study, which provides technical guidelines for the industry and sets an example to summarize the key common technology of clinical research, and also improves the evaluation level of TCM clinical research and efficacy.

Conditions

• Purpura, Schoenlein-Henoch

Interventions

Type	Name	Description
DRUG	Placebo	granules, \<10years,10g,Three times a day,take orally \>10years,20g,Three times a day,take orally fore weeks a period,Observe 2 periods
DRUG	"ziying" granules	granules, \<10years,10g,Three times a day,take orally \>10years,20g,Three times a day,take orally fore weeks a period,Observe 2 periods

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-12-01
• First posted: 2010-04-15
• Last updated: 2010-09-08

Locations

1 site across 1 country: China