Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Neoplasms

Rare Diseases

Thrombocytopenia

Syndrome

Thalassemia

beta-Thalassemia

Anemia

Anemia, Aplastic

Preleukemia

Myelodysplastic Syndromes

Primary Myelofibrosis

Leukopenia

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Blood Platelet Disorders

Cytopenia

Hemolysis

Anemia, Hemolytic

Anemia, Hemolytic, Congenital

Hemoglobinopathies

Genetic Diseases, Inborn

Bone Marrow Failure Disorders

Pancytopenia

Leukocyte Disorders

Beta-thalassemia

Chronic Graft Versus Host Disease

Aplastic Anemia

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

1. Yin deficiency of spleen and kidney
2. Yang deficiency of spleen and kidney
3. Deficiency of both Yin and Yang
4. Stagnation of dampness and poison in the blood
5. Excessive heat and poison

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

Chinese herbal concoction twice a day for 6 months

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.

Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders

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

Quality of life (QOL) will be measured based on the EORTC QLQ C30. THis will be taken at enrolment and at 2 monthly intervals

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.

Shanghai Yueyang Integrated Medicine Hospital

Singapore Bao Zhong Tang TCM Center

Singapore General Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders	NCT01224496	Myelodysplastic... Aplastic Anaemi... Myelofibrosis (... Thalassemia Int...	Chinese herbal ...	13 Years - 85 Years	Singapore General Hospital
Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders	NCT01224496	Myelodysplastic... Aplastic Anaemi... Myelofibrosis (... Thalassemia Int...	Chinese herbal ...	13 Years - 85 Years	Singapore General Hospital

Spots Global Cancer Trial Database for thalassemia intermedia