NCT01104428

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

September 8, 2010

Status Verified

September 1, 2010

Enrollment Period

2.1 years

First QC Date

January 25, 2010

Last Update Submit

September 7, 2010

Conditions

Purpura, Schoenlein-Henoch

Keywords

Hench-schonlein purpuraRenal damageRelapseEnd eventTCM syndrome

Outcome Measures

Primary Outcomes (1)

  • whether endpoint such as renal damage or disease recurrence appears in the participants.

    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.

    6 months

Secondary Outcomes (1)

  • whether the TCM syndrome of participants disappears after treatment.

    1 month

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: Placebo

Drug:"ziying"

EXPERIMENTAL
Drug: "ziying" granules

Interventions

PlaceboDRUG

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

placebo
"ziying" granulesDRUG

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"

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhangjun

Shenyang, Liaoning, 110032, China

RECRUITING

MeSH Terms

Conditions

IgA VasculitisRecurrence

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemostatic DisordersHemorrhagic DisordersSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesImmune Complex DiseasesHypersensitivityImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsDisease Attributes

Study Officials

  • zhang jun, master

    Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

zhang shaoqing, Master

CONTACT

86-024-86291599yanzi8164@163.com

yang guanqi, Master

CONTACT

86-024-86291599

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2010

First Posted

April 15, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2011

Last Updated

September 8, 2010

Record last verified: 2010-09

Locations

CN(1)