Childhood Chronic Immune Thrombocytopenia Clinical Trial
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.
| Status | Terminated |
| Enrollment | 7 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 18 Years |
| Eligibility |
Inclusion Criteria: 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. Exclusion Criteria: 1. Children with thrombocytopenia due to other causes. 2. Refusal of child or guardian to participate. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Medical Organization | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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? | three month | No | |
| Secondary | 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? | three months | No |