A Phase 2 interventional study of Placebo and "ziying" granules in Purpura, Schoenlein-Henoch, sponsored by Liaoning University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2010-09-08.
Sponsored by Liaoning University of Traditional Chinese Medicine · Phase 2, Interventional, and Prevention
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.
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.
36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.
This study's planned enrollment of 256 is above the median of 60 across 19 interventional studies indexed under IgA Vasculitis.
Browse IgA Vasculitis studies →Liaoning University of Traditional Chinese Medicine is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Placebo
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
granules, \<10years,10g,Three times a day,take orally \>10years,20g,Three times a day,take orally fore weeks a period,Observe 2 periods
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.
Time frame: 6 months
whether the TCM syndrome of participants disappears after treatment.
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.
Time frame: 1 month
The record gives a start of Nov 2009 and a primary completion of Dec 2011. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Liaoning University of Traditional Chinese Medicine