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

NCT06760351 | Completed

• 1 other identifier: REC109-61
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 5 months

Secondary Outcomes (2)

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

  Baseline to 5 months

• Incidence of Treatment-Related Adverse Events (Safety)

  Baseline to 5 months

Study Arms (2)

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.

Drug: TCM Herbal Therapy

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.

Drug: Standard Western Medicine Treatment

Interventions

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.

Traditional Chinese Medicine (TCM) Group

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.

Western Medicine Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia-Ying Chuang: lead

Study Sites (1)

Taichung Tzu Chi Hospital

Taichung, Taiwan, 403, Taiwan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Chinese medicine department, Principal Investigator, Resident physician

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: February 26, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available starting 6 months after publication of the study results and will remain accessible for 5 years thereafter.
• Access Criteria: Researchers with a scientifically valid proposal will be granted access to the IPD and supporting documents. Requests should be submitted to the corresponding author and must include a research plan outlining the intended use of the data. Data will be shared through secure, password-protected platforms.

Locations

TW (1)