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

NCT ID: NCT06760351

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2023-12-31

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.

Conditions

Moderate to Severe Anemia; Traditional Chinese Medicine (TCM); Pulse Diagnosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Traditional Chinese Medicine (TCM) Group

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.

TCM Herbal Therapy

Intervention Type: DRUG

Administration of customized herbal formulations for the TCM group, targeting qi and blood regulation. Pulse diagnosis parameters were evaluated monthly to guide treatment adjustments.

Western Medicine Group

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.

Standard Western Medicine Treatment

Intervention Type: DRUG

Administration of standard Western medical care, including blood transfusions and erythropoiesis-stimulating agents, focusing on hemoglobin restoration and anemia management.

Interventions

TCM Herbal Therapy

Administration of customized herbal formulations for the TCM group, targeting qi and blood regulation. Pulse diagnosis parameters were evaluated monthly to guide treatment adjustments.

Intervention Type: DRUG

Standard Western Medicine Treatment

Administration of standard Western medical care, including blood transfusions and erythropoiesis-stimulating agents, focusing on hemoglobin restoration and anemia management.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia-Ying Chuang

OTHER

Sponsor Role: lead

Responsible Party

Chia-Ying Chuang

Doctor of Chinese medicine department, Principal Investigator, Resident physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Taichung Tzu Chi Hospital

Taichung, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

REC109-61

Identifier Type: -

Identifier Source: org_study_id