An observational study in Moderate to Severe Anemia, Traditional Chinese Medicine (TCM) and Pulse Diagnosis, sponsored by Chia-Ying Chuang. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Chia-Ying Chuang · Observational
This observational study evaluates the efficacy and safety of integrated Traditional Chinese Medicine (TCM) and Western medicine in managing moderate to severe anemia. The study examines hemoglobin (Hb) level improvements and correlations with TCM pulse diagnosis parameters at six diagnostic positions (Right and Left Chung, Guan, and Chi). Conducted at Taichung Tzu Chi Hospital, it aims to explore TCM's role as a complementary approach to anemia care while maintaining a focus on patient safety and integrated diagnostic techniques.
The study included 28 patients with moderate to severe anemia (Hb \< 10 g/dL) treated between February 26, 2021, and December 31, 2022. Participants were divided into two groups: those receiving TCM-based interventions (herbal formulations tailored to address systemic imbalances) and those following standard Western medicine protocols. Data collection involved monthly monitoring of Hb levels and pulse diagnosis parameters using the Huang-T1 Sphygmograph, which provided detailed insights into frequency-domain and waveform-derived characteristics.
Primary outcomes included Hb level improvements and safety assessments, while secondary outcomes focused on the correlations between pulse parameters and hematological changes. Results indicated consistent Hb improvements in the TCM group, with notable trends observed in pulse diagnosis correlations. These findings highlight TCM's potential as a diagnostic and therapeutic adjunct in anemia care, emphasizing its role in bridging traditional and modern medical practices.
The study adheres to ethical guidelines, with approval from the Taichung Tzu Chi Hospital Research Ethics Committee (Approval Number: REC109-61). All participants provided written informed consent prior to study inclusion. Future directions include larger-scale studies and randomized controlled trials to further validate findings and expand their clinical applicability.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 28 is below the median of 200 across 326 observational studies indexed under Anemia.
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Participants with moderate to severe anemia receiving treatment at Taichung Tzu Chi Hospital. Study population includes patients managed under TCM and Western medicine frameworks to evaluate integrated care approaches.
Exclusion Criteria:
Participants in this group received individualized TCM herbal formulations tailored to address systemic imbalances observed in moderate to severe anemia. Commonly used formulations include Yougui Wan, Zuogui Wan, and Xiong Gui Jiao Ai Tang. Treatment was monitored monthly with adjustments made based on clinical symptoms and pulse diagnosis parameters.
Drug: TCM Herbal Therapy
Participants in this group were treated using standard Western medical protocols for moderate to severe anemia. Treatments included blood transfusions and erythropoiesis-stimulating agents when necessary, based on clinical evaluations.
Drug: Standard Western Medicine Treatment
Administration of customized herbal formulations for the TCM group, targeting qi and blood regulation. Pulse diagnosis parameters were evaluated monthly to guide treatment adjustments.
Administration of standard Western medical care, including blood transfusions and erythropoiesis-stimulating agents, focusing on hemoglobin restoration and anemia management.
Monthly Change in Hemoglobin Levels (g/dL) to Assess Treatment Efficacy
Monthly measurement of hemoglobin levels (g/dL) to evaluate improvements in anemia severity from baseline over a 5-month study period.
Time frame: Baseline to 5 months
Correlation Between Pulse Diagnosis Parameters and Monthly Hemoglobin Levels (g/dL)
Analysis of the relationship between pulse parameters (e.g., Right Chi Pulse AIr, Right Chung Pulse D Wave) and Hb levels, using data collected monthly from the Huang-T1 Sphygmograph.
Time frame: Baseline to 5 months
Incidence of Treatment-Related Adverse Events (Safety)
Documentation of any adverse events or side effects related to TCM herbal formulations or Western medical treatments, monitored monthly.
Time frame: Baseline to 5 months
Plan to share: Yes — The following individual participant data (IPD) will be shared: anonymized datasets related to hemoglobin levels, pulse diagnosis parameters, and treatment outcomes. All shared data will be de-identified to ensure participant confidentiality.
Supporting information: Study protocol, Sap, Icf, Analytic code
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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