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NCT Number: NCT06760351

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taichung Tzu Chi Hospital

Taichung, Taiwan, 403

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TCM Herbal Therapy

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.

Standard Western Medicine Treatment

Drug

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

Primary outcomes

  1. Monthly Change in Hemoglobin Levels (g/dL) to Assess Treatment Efficacy

    Time frame: 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 outcomes

  1. Correlation Between Pulse Diagnosis Parameters and Monthly Hemoglobin Levels (g/dL)

    Time frame: 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.

  2. Incidence of Treatment-Related Adverse Events (Safety)

    Time frame: Baseline to 5 months

    Documentation of any adverse events or side effects related to TCM herbal formulations or Western medical treatments, monitored monthly.

Sponsors and collaborators

Lead sponsor

Chia-Ying Chuang

Other

Registry information

Official study title

Bridging Traditional Chinese and Western Medicine: Efficacy, Safety, and Diagnostic Advances in a Pilot Cohort-Based Observational Study for Moderate to Severe Anemia

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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