Childhood Chronic Immune ThrombocytopeniaPhase 2/3NCT01226524
The Role of Traditional Chinese Medicine in the Treatment of Chronic Childhood Immune Thrombocytopenia (ITP)
A Phase 2/3 study testing Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan in people with Childhood Chronic Immune Thrombocytopenia, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Immune thrombocytopenia (ITP) is an autoimmune disorder manifested as isolated low platelet count which results in a tendency for bleeding. Around 10% of childhood ITP does not reach resolution within 1 year thus becoming chronic ITP. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Childhood Chronic Immune Thrombocytopenia
- What is being tested?
- Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Aug 2014
- Phase
- Phase 2/3
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Children (< 18 years) diagnosed with chronic ITP; >1 year after a first diagnosis and baseline platelet count < 30,000. The diagnosis of ITP will be the responsibility of the Pediatric Hematology specialist in each participating center.
- -
Who cannot join
- 1. Children with thrombocytopenia due to other causes. 2. Refusal of child or guardian to participate.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Immune thrombocytopenia (ITP) is an autoimmune disorder manifested as isolated low platelet count which results in a tendency for bleeding. Around 10% of childhood ITP does not reach resolution within 1 year thus becoming chronic ITP. Therapeutic modalities at present are aimed to achieve symptomatic relief, do not change the natural course of the disorder and are associated with potential side effects and increase cost. Thus, identifying a new therapy that would decrease the bleeding symptoms, without causing significant adverse effects, could be very beneficial. Preliminary reports demonstrate a beneficial role for Traditional Chinese medicine (TCM) in the treatment of ITP.
Working hypothesis and aims: The use of TCM will improve the status of children with chronic ITP and thus will reduce the need to use conventional medications. The investigators aim to study whether in children with chronic ITP, supplementation with TCM, improves the bleeding symptoms and ITP-related quality of life (QOL) compared to the period prior to the intervention? Methods: The study includes three periods: 1st observation period (1 month), TMC period (3 months) and 2nd observation period (2 months). During all study periods the following data will be collected: bleeding symptoms, bleeding score, platelet count, need for conventional therapy, side effects of therapy and ITP-related QOL.
- Being tested
- Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin DanDrug
A traditional Chinese Medicine (TCM) therapist will diagnose and prescribe the herbal remedies according to TCM principles from one of four formulations or any combination of the four formulation
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine | Experimental | A traditional Chinese Medicine (TCM) therapist will diagnose and prescribe the herbal remedies according to TCM principles from one of four formulations or any combination of the four formulations, i.e. Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan Receives: Drug: Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether in children with chronic ITP, does supplementation with Traditional Chinese Medicine remedies, reduces symptomatic bleeding episodes compared to the period prior to intervention?
Measured: three month
Secondary outcomes (1)
To determine whether in children with chronic ITP, does supplementation with TCM remedies, improves the disease related quality of life compared to the period prior to intervention?
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startFeb 2011
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Chronic Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoshana Vilk, Hadassah Medical Organization
- Investigators
- Shoshana Revel-Vilk, MD, MSc, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226524
- Sponsor's protocol ID
- ITP-HMO-CTIL
- Status last verified
- Mar 2011
- First submitted
- 21 Oct 2010
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Traditional Chinese Medicine in the Treatment of Chronic Childhood Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT01226524
- Acronym / sponsor ID
- ITP-HMO-CTIL
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Oct 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.
Immune thrombocytopenia (ITP) is an autoimmune disorder manifested as isolated low platelet count which results in a tendency for bleeding. Around 10% of childhood ITP does not reach resolution within 1 year thus becoming chronic ITP. Therapeutic modalities at present are aimed to achieve symptomatic relief, do not change the natural course of the disorder and are associated with potential side effects and increase cost. Thus, identifying a new therapy that would decrease the bleeding symptoms, without causing significant adverse effects, could be very beneficial. Preliminary reports demonstrate a beneficial role for Traditional Chinese medicine (TCM) in the treatment of ITP.
Working hypothesis and aims: The use of TCM will improve the status of children with chronic ITP and thus will reduce the need to use conventional medications. The investigators aim to study whether in children with chronic ITP, supplementation with TCM, improves the bleeding symptoms and ITP-related quality of life (QOL) compared to the period prior to the intervention? Methods: The study includes three periods: 1st observation period (1 month), TMC period (3 months) and 2nd observation period (2 months). During all study periods the following data will be collected: bleeding symptoms, bleeding score, platelet count, need for conventional therapy, side effects of therapy and ITP-related QOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine | Experimental | Drug: Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin DanA traditional Chinese Medicine (TCM) therapist will diagnose and prescribe the herbal remedies according to TCM principles from one of four formulations or any combination of the four formulations, i.e. Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 1. Children (< 18 years) diagnosed with chronic ITP; >1 year after a first diagnosis and baseline platelet count < 30,000. The diagnosis of ITP will be the responsibility of the Pediatric Hematology specialist in each participating center.
- -
Key exclusion criteria (2 listed)
- 1. Children with thrombocytopenia due to other causes. 2. Refusal of child or guardian to participate.
- -
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 |
|---|---|---|
| Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin DanA traditional Chinese Medicine (TCM) therapist will diagnose and prescribe the herbal remedies according to TCM principles from one of four formulations or any combination of the four formulation | Drug | Traditional Chinese Medicine |
Primary outcome
To determine whether in children with chronic ITP, does supplementation with Traditional Chinese Medicine remedies, reduces symptomatic bleeding episodes compared to the period prior to intervention?
Time frame: three month
1 secondary outcome
To determine whether in children with chronic ITP, does supplementation with TCM remedies, improves the disease related quality of life compared to the period prior to intervention?
Time frame: three months
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
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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.
Shoshana Revel-Vilk, MD, MSc principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan in people with Childhood Chronic Immune Thrombocytopenia, run by Hadassah Medical Organization at 1 site in Israel.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 18 Aug 2015. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether in children with chronic ITP, does supplementation with Traditional Chinese Medicine remedies, reduces symptomatic bleeding episodes compared to the period prior to intervention? (time frame: three month). 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 18 Aug 2015.