Moderate to Severe AnemiaNCT06760351
Pulse Diagnosis and Anemia: Exploring Integrated Traditional Chinese and Western Medicine Approaches
An observational study of Moderate to Severe Anemia and Traditional Chinese Medicine (TCM), run by Chia-Ying Chuang at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Moderate to Severe Anemia, Traditional Chinese Medicine (TCM), Pulse Diagnosis
- What is being tested?
- TCM Herbal Therapy and Standard Western Medicine Treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- TCM Herbal Therapy, Standard Western Medicine Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM Herbal TherapyDrug
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 TreatmentDrug
Administration of standard Western medical care, including blood transfusions and erythropoiesis-stimulating agents, focusing on hemoglobin restoration and anemia management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard Western Medicine Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 5 months
Secondary outcomes (2)
Correlation Between Pulse Diagnosis Parameters and Monthly Hemoglobin Levels (g/dL)
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.
Measured: Baseline to 5 months
Incidence of Treatment-Related Adverse Events (Safety)
Documentation of any adverse events or side effects related to TCM herbal formulations or Western medical treatments, monitored monthly.
Measured: Baseline to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start26 Feb 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia-Ying Chuang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chia-Ying Chuang, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760351
- Sponsor's protocol ID
- REC109-61
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The following individual participant data (IPD) will be shared: anonymized datasets related to hemoglobin levels, pulse diagnosis parameters, and treatment outcomes. All shared data will be de-identified to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06760351
- Acronym / sponsor ID
- REC109-61
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chia-Ying ChuangUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine (TCM) Group | – | Drug: TCM Herbal TherapyParticipants 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 | – | Drug: Standard Western Medicine TreatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCM Herbal TherapyAdministration of customized herbal formulations for the TCM group, targeting qi and blood regulation. Pulse diagnosis parameters were evaluated monthly to guide treatment adjustments. | Drug | Traditional Chinese Medicine (TCM) Group |
| Standard Western Medicine TreatmentAdministration of standard Western medical care, including blood transfusions and erythropoiesis-stimulating agents, focusing on hemoglobin restoration and anemia management. | Drug | Western Medicine Group |
Primary outcome
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.
2 secondary outcomes
Correlation Between Pulse Diagnosis Parameters and Monthly Hemoglobin Levels (g/dL)
Time frame: Baseline to 5 months
Incidence of Treatment-Related Adverse Events (Safety)
Time frame: Baseline to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: Yes. The following individual participant data (IPD) will be shared: anonymized datasets related to hemoglobin levels, pulse diagnosis parameters, and treatment outcomes. All shared data will be de-identified to ensure participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate to Severe Anemia and Traditional Chinese Medicine (TCM), run by Chia-Ying Chuang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly Change in Hemoglobin Levels (g/dL) to Assess Treatment Efficacy (time frame: Baseline to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.