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临床试验/NCT01226524
NCT01226524终止2 期

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

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
7
试验地点
1
主要终点
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?

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Traditional Chinese Medicine

Experimental

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

干预措施: Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan (Drug)

结局指标

主要结局

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?

时间窗: three month

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shoshana Vilk

Prof. Shoshana Revel-Villk

Hadassah Medical Organization

研究点 (1)

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