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

NCT ID: NCT01226524

Last Updated: 2015-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-08-31

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.

Conditions

Childhood Chronic Immune Thrombocytopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional Chinese Medicine

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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 formulation

Intervention Type: DRUG

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.

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Exclusion Criteria

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

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• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Shoshana Vilk

Prof. Shoshana Revel-Villk

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shoshana Revel-Vilk, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Other Identifiers

ITP-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id