Clinical trial NCT06760351: Pulse Diagnosis and Anemia: Exploring Integrated Traditional Chinese and Western Medicine Approaches
Official title: Bridging Traditional Chinese and Western Medicine: Efficacy, Safety, and Diagnostic Advances in a Pilot Cohort-Based Observational Study for Moderate to Severe Anemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate to Severe Anemia
Traditional Chinese Medicine (TCM)
Pulse Diagnosis
Lead sponsor: Taichung Tzu Chi Hospital
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of moderate to severe anemia (Hb \< 10 g/dL).
* Age between 18 and 90 years.
* Willingness to provide informed consent and comply with study procedures.
* Ability to attend monthly follow-up visits and provide clinical data for analysis.

Exclusion Criteria:

* Presence of psychiatric disorders affecting compliance.
* Significant organ diseases, such as chronic obstructive pulmonary disease, advanced liver disease, or heart failure.
* Pregnancy or lactation.
* Concurrent participation in other clinical trials or use of investigational drugs within the past 30 days.
* Non-compliance with follow-up schedules or study protocols.

Primary outcomes:
measure: Monthly Change in Hemoglobin Levels (g/dL) to Assess Treatment Efficacy
timeFrame: Baseline to 5 months
Secondary outcomes:
measure: Correlation Between Pulse Diagnosis Parameters and Monthly Hemoglobin Levels (g/dL)
timeFrame: Baseline to 5 months
measure: Incidence of Treatment-Related Adverse Events (Safety)
timeFrame: Baseline to 5 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Tzu Chi Hospital
Study officials:
References: