The Role of Traditional Chinese Medicine in the Treatment of Chronic Childhood Immune Thrombocytopenia (ITP)

Last updated: August 17, 2015
Sponsor: Hadassah Medical Organization
Overall Status: Terminated

Phase

2/3

Condition

Thrombosis

Dysfunctional Uterine Bleeding

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT01226524
ITP-HMO-CTIL
  • Ages 1-18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Children (< 18 years) diagnosed with chronic ITP; >1 year after a first diagnosis andbaseline platelet count < 30,000. The diagnosis of ITP will be the responsibility of thePediatric Hematology specialist in each participating center.

Exclusion

Exclusion Criteria:

  1. Children with thrombocytopenia due to other causes. 2. Refusal of child or guardian toparticipate.

Study Design

Total Participants: 7
Study Start date:
February 01, 2011
Estimated Completion Date:
August 31, 2014

Connect with a study center

  • Hadassah Medical Organization

    Jerusalem, 91120
    Israel

    Site Not Available

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