Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura
Recruitment status was Recruiting
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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 |
- 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.
- 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 |
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| Contact: zhang shaoqing, Master | 86-024-86291599 | yanzi8164@163.com |
| Contact: yang guanqi, Master | 86-024-86291599 |
| 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 | |
| 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 Affiliated to Beijing University of Chinese Medicine |
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 May 22, 2013