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

Phase 2

Terminated

• Conditions: Childhood Chronic Immune Thrombocytopenia
• Interventions: Drug: Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan

• Registration Number: NCT01226524
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Study Start: 2011-02
• Status Verified: 2011-03
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Traditional Chinese Medicine	Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel