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

NCT ID: NCT01104428

Last Updated: 2010-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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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

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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

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Purpura, Schoenlein-Henoch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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"

Group Type EXPERIMENTAL

"ziying" granules

Intervention Type DRUG

granules, \<10years,10g,Three times a day,take orally \>10years,20g,Three times a day,take orally fore weeks a period,Observe 2 periods

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongzhimen Hospital, Beijing

OTHER

Sponsor Role collaborator

Shenyang Hospital of Integrated Traditional and westen Medicine

UNKNOWN

Sponsor Role collaborator

Dalian Children's Hospital

OTHER

Sponsor Role collaborator

Liaoning University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Principal Investigators

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zhang jun, master

Role: STUDY_CHAIR

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

zhao lijun, master

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

wang shaojie, master

Role: PRINCIPAL_INVESTIGATOR

Dalian Children's Hospital

ma liming, master

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

li tienan, master

Role: PRINCIPAL_INVESTIGATOR

Shenyang Hospital of Integrated Traditional and westen Medicine

xu rongqian, master

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Locations

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Zhangjun

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zhang shaoqing, Master

Role: CONTACT

[email protected]
86-024-86291599

yang guanqi, Master

Role: CONTACT

86-024-86291599

Facility Contacts

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zhang shaoqing, master

Role: primary

[email protected]
86-024-86291599

yang guanqi, master

Role: backup

86-024-86291599

Other Identifiers

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zhangjun555678

Identifier Type: -

Identifier Source: org_study_id