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

Tracking Information
First Submitted Date ICMJE	January 25, 2010
First Posted Date ICMJE	April 15, 2010
Last Update Posted Date	September 8, 2010
Study Start Date ICMJE	November 2009
Estimated Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 13, 2010)	whether endpoint such as renal damage or disease recurrence appears in the participants. [ Time Frame: 6 months ]; Endpoint is a mark of termination or completion. In this clinical research, the renal damage and disease recurrence that constitutes the target outcomes of the trial.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01104428 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 13, 2010)	whether the TCM syndrome of participants disappears after treatment. [ Time Frame: 1 month ]; 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 In the process of disease of a series of function, metabolism and morphological structure changes caused by the subjective feeling of abnormal patient as symptoms.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura
Official Title ICMJE	Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura
Brief 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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Condition ICMJE	Purpura, Schoenlein-Henoch
Intervention ICMJE	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
Study Arms	Placebo Comparator: placebo Intervention: Drug: Placebo; Experimental: Drug:"ziying" Intervention: Drug: "ziying" granules
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: April 13, 2010)	256
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Estimated Primary Completion Date	December 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: To comply with the diagnostic standard of purpura in TCM and Hench-schonlein purpura in western medicine;; To comply with the diagnostic standard of TCM syndrome differentiation;; Age between 5 and 18;; without similar herbal treatment a week before being included;; Informed Consent Form is required to be singed. Exclusion Criteria: Fall short of the diagnostic standard of purpura in TCM and Hench-schonlein purpura in western medicine;; Fall short of the diagnostic standard of TCM syndrome differentiation;; Older then 18 years or younger then 5years;; Take similar herbal treatment within a week before being included;; Can not take the drug according to the regulation or follow-up on time; Patients combine serious primary disease in respiratory、gastrointestinal、hemopoietic、renal，or psychosis,or pestilence;; Allergic to drugs of this research or others;; human subject of other clinical research in the nearly tow weeks.
Sex/Gender	Sexes Eligible for Study: All
Ages	5 Years to 18 Years (Child, Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	China
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01104428
Other Study ID Numbers ICMJE	zhangjun555678
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	President Guanlin Yang, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Study Sponsor ICMJE	Liaoning University of Traditional Chinese Medicine
Collaborators ICMJE	Dongzhimen Hospital, Beijing; Shenyang Hospital of Integrated Traditional and westen Medicine; Dalian Children's Hospital
Investigators ICMJE	Study Chair: zhang jun, master Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Principal Investigator: zhao lijun, master Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Principal Investigator: wang shaojie, master Dalian Children's Hospital Principal Investigator: ma liming, master Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Principal Investigator: li tienan, master Shenyang Hospital of Integrated Traditional and westen Medicine Principal Investigator: xu rongqian, master Dongzhimen Hospital, Beijing
PRS Account	Liaoning University of Traditional Chinese Medicine
Verification Date	September 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP