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| Name | Class |
|---|---|
| Shanghai Yueyang Integrated Medicine Hospital | OTHER |
| Singapore Bao Zhong Tang TCM Center | UNKNOWN |
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The purpose of this study is to study the efficacy of Traditional Chinese Medicine (TCM) on anaemic and cytopenic haematological disorders including myelodysplastic syndrome (MDS), aplastic anaemia (AA), myelofibrosis (MF) and thalassemia intermedia who do not have or did not respond to available treatment options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Chinese herbal concoction | Experimental | Patients must have a marrow study to confirm diagnosis of MDS, AA or MF. MDS is classified according to the WHO criteria and scored according to IPSS. The AA group is further classified into AA, SAA or VSAA . MF is defined by the Italian criteria and risk stratified by the Lilles Scoring system. Diagnosis of thal intermedia and major is based on previously done Hb electrophoresis and severity of disease is assessed by degree of anaemia.and frequency of blood transfusions TCM diagnosis: Syndrome differentiation according to TCM theory will be assessed as a baseline by experienced TCM collaborators and classified into one of the few defined syndromes as follows
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese herbal concoction twice a day for 6 months | Drug | Definition of each TCM syndrome is based on TCM theory. Formulation composition is based on each defined TCM syndrome with addition or removal of herbs as indicated by the patient's manifestation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | The following parameters will be monitored serially
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life (QOL) will be measured based on the EORTC QLQ C30. THis will be taken at enrolment and at 2 monthly intervals | 6 months |
| Haematological improvement | The haematological response crietria is based on those published as follows For MDS : Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood 2000 Dec 1;96(12):3671-4. For MF : Response criteria for myelofibrosis with myeloid metaplasia: results of an initiative of the European Myelofibrosis Network (EUMNET). Blood 2005 Oct 15;106(8):2849-53. For AA : Aplastic Anemia, Pathophysiology and Treatment. Cambridge: Cambridge University Press; 2000. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Singapore | Singapore | 169608 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21742281 | Derived | Linn YC, Lu J, Lim LC, Sun H, Sun J, Zhou Y. Traditional Chinese herbal medicine in the supportive management of patients with chronic cytopaenic marrow diseases -- a phase I/II clinical study. Complement Ther Clin Pract. 2011 Aug;17(3):152-6. doi: 10.1016/j.ctcp.2011.01.004. Epub 2011 Feb 17. |
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| 6 months |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D000741 | Anemia, Aplastic |
| D055728 | Primary Myelofibrosis |
| D017086 | beta-Thalassemia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000740 | Anemia |
| D000080983 | Bone Marrow Failure Disorders |
| D009196 | Myeloproliferative Disorders |
| D013789 | Thalassemia |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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