Clinical trial NCT01104428: Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura
Official title: Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Purpura, Schoenlein-Henoch
Keywords: Hench-schonlein purpura
Renal damage
Relapse
End event
TCM syndrome
Lead sponsor: Liaoning University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Dongzhimen Hospital, Beijing
name: Shenyang Hospital of Integrated Traditional and westen Medicine
name: Dalian Children's Hospital
First posted: 2010-04-15
Enrollment: 256
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: whether endpoint such as renal damage or disease recurrence appears in the participants.
timeFrame: 6 months
Secondary outcomes:
measure: whether the TCM syndrome of participants disappears after treatment.
timeFrame: 1 month
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Zhangjun
state: Liaoning
Study officials:
affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: zhang jun, master
role: STUDY_CHAIR
affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: zhao lijun, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalian Children's Hospital
name: wang shaojie, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: ma liming, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenyang Hospital of Integrated Traditional and westen Medicine
name: li tienan, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongzhimen Hospital, Beijing
name: xu rongqian, master
role: PRINCIPAL_INVESTIGATOR
References: