Status:
COMPLETED
Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders
Lead Sponsor:
Singapore General Hospital
Collaborating Sponsors:
Shanghai Yueyang Integrated Medicine Hospital
Singapore Bao Zhong Tang TCM Center
Conditions:
Myelodysplastic Syndrome (MDS)
Aplastic Anaemia (AA)
Eligibility:
All Genders
13-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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 (A...
Eligibility Criteria
Inclusion
- A diagnosis of MDS, AA, MF or thal based on currently recognized diagnostic criteria.
- Explored or undergone established therapies eg haemopoietic stem cell transplant, immunosuppressive therapy, chemotherapy, growth factors, thalidomide, hypomethylating agent or androgens, and (a) are deemed not suitable, or (b) refuse or (c) have failed therapy
- A preceding follow up period (without or with treatment) of 2-4 months as baseline (depending on the severity of cytopenia) before being enrolled into this study
- Understand the trial nature of this treatment, agree to be compliant to medication, do not self medicate and have signed informed consent
- Agreeable to regular blood tests and follow up marrow study as listed in schedule
Exclusion
- Life expectancy of shorter than one year
- Significant organ failure including the following
- Renal impairment with Cr above 200umol/L
- Liver impairment with serum bilirubin \> 2x upper limits or transaminase \>3x upper limits
- Escalation of treatment of introduction of new agents including growth factors, thalidomide, hypomethylating agents, immunosuppressive therapy or androgens once started on treatment with TCM is not allowed. Continuation of current therapy at same or lower doses is allowed
- Women during pregnancy or lactation.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01224496
Start Date
July 1 2009
End Date
August 1 2011
Last Update
February 10 2017
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, Singapore, 169608