Study Stopped
Slow recruitment
Sponsor study identifier
interventional
7
1 country
1
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2010
Actual (reported)October 22, 2010
Actual (reported)February 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 2014
Actual (reported)August 2014
Actual (reported)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
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
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hadassah Medical Organization
Jerusalem, 91120, Israel
Shoshana Revel-Vilk, MD, MSc
Hadassah Medical Organization
7 participants (actual enrollment reported by the registry).
First Submitted
October 21, 2010
First Posted
October 22, 2010
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
August 18, 2015
Record last verified: 2011-03
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Source: ClinicalTrials.gov.
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