Pulse Diagnosis and Anemia: Exploring Integrated Traditional Chinese and Western Medicine Approaches

Completed

• Conditions: Moderate to Severe Anemia; Traditional Chinese Medicine (TCM); Pulse Diagnosis
• Interventions: Drug: TCM Herbal Therapy; Drug: Standard Western Medicine Treatment

• Registration Number: NCT06760351
• Lead Sponsor: Chia-Ying Chuang

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.

Study Timeline

• Study Start: 2021-02-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2024-12-29
• Status Verified: 2025-01
• Study First Posted: 2025-01-06
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Traditional Chinese Medicine (TCM) Group	TCM Herbal Therapy	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.
Western Medicine Group	Standard Western Medicine Treatment	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.

Primary Outcome Measures

Name	Time	Method
Monthly Change in Hemoglobin Levels (g/dL) to Assess Treatment Efficacy	Baseline to 5 months	Monthly measurement of hemoglobin levels (g/dL) to evaluate improvements in anemia severity from baseline over a 5-month study period.

Secondary Outcome Measures

Name	Time	Method
Correlation Between Pulse Diagnosis Parameters and Monthly Hemoglobin Levels (g/dL)	Baseline to 5 months	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.
Incidence of Treatment-Related Adverse Events (Safety)	Baseline to 5 months	Documentation of any adverse events or side effects related to TCM herbal formulations or Western medical treatments, monitored monthly.

Trial Locations

Locations (1)

Taichung Tzu Chi Hospital; 🇨🇳 Taichung, Taiwan