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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients

NCT01359501

Leucopenia Breast Cancer

UNKNOWN PHASE2

Clinical Observation of Integrated Chinese Medicine With Western Medicine for the Reduction of Chemotherapy-induced Hematologic Toxicity

NCT05442177

Myelosuppression

COMPLETED

Compound Herbal Formula (TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy

NCT01142479

Breast Cancer Radiotherapy Chinese Herbal Medicine

COMPLETED PHASE2/PHASE3

Health-related Quality of Life-intervention in Survivors of Breast and Other Cancers Experiencing Cancer-related Fatigue Using Traditional Chinese Medicine: The HERBAL Trial

NCT04104113

Cancer Fatigue Cognitive Impairment

UNKNOWN PHASE2

An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo

NCT05483595

Placebo Evaluate

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myelodysplastic Syndrome (MDS) Aplastic Anaemia (AA) Myelofibrosis (MF) Thalassemia Intermedia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment with Chinese herbal concoction

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

Group Type EXPERIMENTAL

Chinese herbal concoction twice a day for 6 months

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chinese herbal concoction twice a day for 6 months

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. A diagnosis of MDS, AA, MF or thal based on currently recognized diagnostic criteria.
2. 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
3. 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
4. Understand the trial nature of this treatment, agree to be compliant to medication, do not self medicate and have signed informed consent
5. Agreeable to regular blood tests and follow up marrow study as listed in schedule

Exclusion Criteria

1. Life expectancy of shorter than one year
2. Significant organ failure including the following
3. Renal impairment with Cr above 200umol/L
4. Liver impairment with serum bilirubin \> 2x upper limits or transaminase \>3x upper limits
5. 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
6. Women during pregnancy or lactation.

Minimum Eligible Age

13 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No