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

Primary Purpose

Childhood Chronic Immune Thrombocytopenia

Status

Terminated

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan

About this trial

This is an interventional treatment trial for Childhood Chronic Immune Thrombocytopenia

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hadassah Medical Organization

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Traditional Chinese Medicine

Arm Description

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

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

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?

Full Information

NCT ID

NCT01226524

First Posted

October 21, 2010

Last Updated

August 17, 2015

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01226524

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Terminated

Why Stopped

Slow recruitment

Study Start Date

February 2011 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Childhood Chronic Immune Thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Traditional Chinese Medicine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shoshana Revel-Vilk, MD, MSc

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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