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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2010 by Liaoning University of Traditional Chinese Medicine.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01104428

First Posted: April 15, 2010

Last Update Posted: September 8, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Dongzhimen Hospital, Beijing

Shenyang Hospital of Integrated Traditional and westen Medicine

Dalian Children's Hospital

Information provided by:

Liaoning University of Traditional Chinese Medicine

Tracking Information

First Submitted Date ^ICMJE

January 25, 2010

First Posted Date ^ICMJE

April 15, 2010

Last Update Posted Date

September 8, 2010

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

256

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

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

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