Purpura, Schoenlein-HenochPhase 2NCT01104428
Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura
A Phase 2 study testing "ziying" granules in people with Purpura, Schoenlein-Henoch, run by Liaoning University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Purpura, Schoenlein-Henoch
- What is being tested?
- "ziying" granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
yang guanqi, Master contact
China1 site, 1 recruiting
- Recruiting
Zhangjun
Shenyang, Liaoning, 110032
zhang shaoqing, master, 86-024-86291599, yanzi8164@163.com
yang guanqi, master, 86-024-86291599
About this study
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.
Read the 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.
- Conditions
- Purpura, Schoenlein-Henoch
- Being tested
- Placebo, "ziying" granules
- Keywords
- Hench-schonlein purpura, Renal damage, Relapse, End event, TCM syndrome
- Medical subject headings
- IgA Vasculitis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
granules, <10years,10g,Three times a day,take orally >10years,20g,Three times a day,take orally fore weeks a period,Observe 2 periods
"ziying" granulesDrug
granules, <10years,10g,Three times a day,take orally >10years,20g,Three times a day,take orally fore weeks a period,Observe 2 periods
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Drug:"ziying" | Experimental | Not described Receives: Drug: "ziying" granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Purpura, Schoenlein-HenochStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Dongzhimen Hospital, Beijing, Shenyang Hospital of Integrated Traditional and westen Medicine, Dalian Children's Hospital
- Investigators
- zhang jun, master, Study chair, Affiliated Hospital of Liaoning University of Traditional Chinese Medicinezhao lijun, master, Principal investigator, Affiliated Hospital of Liaoning University of Traditional Chinese Medicinewang shaojie, master, Principal investigator, Dalian Children's Hospitalma liming, master, Principal investigator, Affiliated Hospital of Liaoning University of Traditional Chinese Medicineli tienan, master, Principal investigator, Shenyang Hospital of Integrated Traditional and westen Medicinexu rongqian, master, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104428
- Sponsor's protocol ID
- zhangjun555678
- Status last verified
- Sep 2010
- First submitted
- 25 Jan 2010
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura
- ClinicalTrials.gov ID
- NCT01104428
- Acronym / sponsor ID
- zhangjun555678
- Conditions
- Purpura, Schoenlein-Henoch
- Keywords
- Hench-schonlein purpura, Renal damage, Relapse, End event, TCM syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Liaoning University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Dongzhimen Hospital, Beijing, Shenyang Hospital of Integrated Traditional and westen Medicine, Dalian Children's Hospital
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (estimated)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo |
| Drug:"ziying" | Experimental | Drug: "ziying" granules |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebogranules, <10years,10g,Three times a day,take orally >10years,20g,Three times a day,take orally fore weeks a period,Observe 2 periods | Drug | placebo |
| "ziying" granulesgranules, <10years,10g,Three times a day,take orally >10years,20g,Three times a day,take orally fore weeks a period,Observe 2 periods | Drug | Drug:"ziying" |
Primary outcome
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.
1 secondary outcome
whether the TCM syndrome of participants disappears after treatment.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yang guanqi, Master contact
zhang jun, master study chair
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
zhao lijun, master principal investigator
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
wang shaojie, master principal investigator
Dalian Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "ziying" granules in people with Purpura, Schoenlein-Henoch, run by Liaoning University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhang shaoqing, Master (86-024-86291599, yanzi8164@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
whether endpoint such as renal damage or disease recurrence appears in the participants. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2010.