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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
38
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
Singapore General Hospital
Singapore, Singapore, Singapore
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The following parameters will be monitored serially 1. symptoms : ie reflection of any subjective symptoms that may be due to the treatment 2. Serial biochemistry ( urea, electrolyte, creatinine, liver function test ) will be done at baseline, one week into the study and then every 7-8 weekly till end of the 6 months. This will monitor for any organ toxicity
Time frame: 6 months
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
Time frame: 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.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.