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

September 7, 2010 updated by: Liaoning University of Traditional Chinese Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: zhang shaoqing, master
  • Phone Number: 86-024-86291599
  • Email: yanzi8164@163.com

Study Contact Backup

  • Name: yang guanqi, master
  • Phone Number: 86-024-86291599

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110032
        • Recruiting
        • Zhangjun
        • Contact:
        • Contact:
          • yang guanqi, master
          • Phone Number: 86-024-86291599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
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
EXPERIMENTAL: Drug:"ziying"
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaoning University of Traditional Chinese Medicine

Collaborators

Dongzhimen Hospital, Beijing
Dalian Children's Hospital
Shenyang Hospital of Integrated Traditional and westen Medicine

Investigators

  • Study Chair: zhang jun, master, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Principal Investigator: zhao lijun, master, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Principal Investigator: wang shaojie, master, Dalian Children's Hospital
  • Principal Investigator: ma liming, master, First 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (ESTIMATE)

April 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 8, 2010

Last Update Submitted That Met QC Criteria

September 7, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zhangjun555678

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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