Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura
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ClinicalTrials.gov Identifier: NCT01104428 |
Recruitment Status
: Unknown
Verified September 2010 by Liaoning University of Traditional Chinese Medicine.
Recruitment status was: Recruiting
First Posted
: April 15, 2010
Last Update Posted
: September 8, 2010
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Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | January 25, 2010 | ||||||||||||||||||
First Posted Date ICMJE | April 15, 2010 | ||||||||||||||||||
Last Update Posted Date | September 8, 2010 | ||||||||||||||||||
Study Start Date ICMJE | November 2009 | ||||||||||||||||||
Estimated Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | Complete list of historical versions of study NCT01104428 on ClinicalTrials.gov Archive Site | ||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura | ||||||||||||||||||
Official Title ICMJE | Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura | ||||||||||||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase | Phase 2 | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Purpura, Schoenlein-Henoch | ||||||||||||||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Unknown status | ||||||||||||||||||
Estimated Enrollment ICMJE |
256 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Study Completion Date | Not Provided | ||||||||||||||||||
Estimated Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 5 Years to 18 Years (Child, Adult) | ||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | China | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT01104428 | ||||||||||||||||||
Other Study ID Numbers ICMJE | zhangjun555678 | ||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||||||||
Responsible Party | President Guanlin Yang, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | ||||||||||||||||||
Study Sponsor ICMJE | Liaoning University of Traditional Chinese Medicine | ||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Liaoning University of Traditional Chinese Medicine | ||||||||||||||||||
Verification Date | September 2010 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |