Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-29 @ 2:31 AM
Study NCT ID:
NCT06760351
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2024-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Diagnosis and Anemia: Exploring Integrated Traditional Chinese and Western Medicine Approaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2024-12-29', 'studyFirstSubmitQcDate': '2024-12-29', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monthly Change in Hemoglobin Levels (g/dL) to Assess Treatment Efficacy', 'timeFrame': 'Baseline to 5 months', 'description': 'Monthly measurement of hemoglobin levels (g/dL) to evaluate improvements in anemia severity from baseline over a 5-month study period.'}], 'secondaryOutcomes': [{'measure': 'Correlation Between Pulse Diagnosis Parameters and Monthly Hemoglobin Levels (g/dL)', 'timeFrame': 'Baseline to 5 months', 'description': '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.'}, {'measure': 'Incidence of Treatment-Related Adverse Events (Safety)', 'timeFrame': 'Baseline to 5 months', 'description': 'Documentation of any adverse events or side effects related to TCM herbal formulations or Western medical treatments, monitored monthly.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Anemia', 'Traditional Chinese Medicine (TCM)', 'Pulse Diagnosis']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nPrimary 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of moderate to severe anemia (Hb \\< 10 g/dL).\n* Age between 18 and 90 years.\n* Willingness to provide informed consent and comply with study procedures.\n* Ability to attend monthly follow-up visits and provide clinical data for analysis.\n\nExclusion Criteria:\n\n* Presence of psychiatric disorders affecting compliance.\n* Significant organ diseases, such as chronic obstructive pulmonary disease, advanced liver disease, or heart failure.\n* Pregnancy or lactation.\n* Concurrent participation in other clinical trials or use of investigational drugs within the past 30 days.\n* Non-compliance with follow-up schedules or study protocols.'}, 'identificationModule': {'nctId': 'NCT06760351', 'briefTitle': 'Pulse Diagnosis and Anemia: Exploring Integrated Traditional Chinese and Western Medicine Approaches', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Tzu Chi Hospital'}, 'officialTitle': 'Bridging Traditional Chinese and Western Medicine: Efficacy, Safety, and Diagnostic Advances in a Pilot Cohort-Based Observational Study for Moderate to Severe Anemia', 'orgStudyIdInfo': {'id': 'REC109-61'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Traditional Chinese Medicine (TCM) Group', 'description': '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.', 'interventionNames': ['Drug: TCM Herbal Therapy']}, {'label': 'Western Medicine Group', 'description': '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.', 'interventionNames': ['Drug: Standard Western Medicine Treatment']}], 'interventions': [{'name': 'TCM Herbal Therapy', 'type': 'DRUG', 'description': 'Administration of customized herbal formulations for the TCM group, targeting qi and blood regulation. Pulse diagnosis parameters were evaluated monthly to guide treatment adjustments.', 'armGroupLabels': ['Traditional Chinese Medicine (TCM) Group']}, {'name': 'Standard Western Medicine Treatment', 'type': 'DRUG', 'description': 'Administration of standard Western medical care, including blood transfusions and erythropoiesis-stimulating agents, focusing on hemoglobin restoration and anemia management.', 'armGroupLabels': ['Western Medicine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '403', 'city': 'Taichung', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Taichung Tzu Chi Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'IPD and supporting information will be available starting 6 months after publication of the study results and will remain accessible for 5 years thereafter.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia-Ying Chuang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor of Chinese medicine department, Principal Investigator, Resident physician', 'investigatorFullName': 'Chia-Ying Chuang', 'investigatorAffiliation': 'Taichung Tzu Chi Hospital'}}}}