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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Liaoning University of Traditional Chinese Medicine.
Recruitment status was  Recruiting
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01104428
First received: January 25, 2010
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Purpura, Schoenlein-Henoch
Drug: Placebo
Drug: "ziying" granules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura

Resource links provided by NLM:


Further study details as provided by Liaoning University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • whether endpoint such as renal damage or disease recurrence appears in the participants. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • whether the TCM syndrome of participants disappears after treatment. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 256
Study Start Date: November 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104428

Contacts
Contact: zhang shaoqing, Master 86-024-86291599 yanzi8164@163.com
Contact: yang guanqi, Master 86-024-86291599

Locations
China, Liaoning
Zhangjun Recruiting
Shenyang, Liaoning, China, 110032
Contact: zhang shaoqing, master    86-024-86291599    yanzi8164@163.com   
Contact: yang guanqi, master    86-024-86291599      
Sponsors and Collaborators
Liaoning University of Traditional Chinese Medicine
Dongzhimen Hospital, Beijing
Shenyang Hospital of Integrated Traditional and westen Medicine
Dalian Children's Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: President Guanlin Yang, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01104428     History of Changes
Other Study ID Numbers: zhangjun555678
Study First Received: January 25, 2010
Last Updated: September 7, 2010
Health Authority: China:State Administration of Trditional Chinese Medicine of the People's Republic of China

Keywords provided by Liaoning University of Traditional Chinese Medicine:
Hench-schonlein purpura
Renal damage
Relapse
End event
TCM syndrome

Additional relevant MeSH terms:
Purpura
Purpura, Schoenlein-Henoch
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Immune Complex Diseases
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014