Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT06141902
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-19
First Post:
2023-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Jing Si Herbal Tea on Physical and Psychological Symptoms in Peripheral Blood Hematopoietic Stem Cell Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2023-11-05', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in pain assessed by questionnaires', 'timeFrame': '5 day', 'description': 'For each of the pain sites includes: headache、bone、joint \\& muscle, indicate the severity of present using the following scale (baseline vs. follow-up).\n\ngrade 0: fully active, able to carry on all pre-disease performance without restriction\n\ngrade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work\n\ngrade 2: ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours\n\ngrade 3: capable of only limited self-care, confined to bed or chair more than 50% of waking hours\n\ngrade 4: completely disabled, cannot carry on any self-care, totally confined to bed or chair\n\ngrade 5: dead'}], 'secondaryOutcomes': [{'measure': 'Changes in anxiety assessed by questionnaires', 'timeFrame': '21 days', 'description': 'Difference in donor Health State Trait Anxiety Index (STAI) scores (baseline vs. follow-up).\n\nThe STAI questionnaire consists of 20 items for assessing "state anxiety" and 20 items for assessing "trait anxiety," with a raw score of 20 to 60 points for each scale.\n\nThe state anxiety scale evaluates the current state of anxiety associated with a special situation, measuring subjective feelings of apprehension, tension, nervousness, worry, and activation of the autonomic nervous system, whereas the trait anxiety scale evaluates proneness to anxiety .\n\nThe level of anxiety was determined according to the percentile rank obtained using the raw score of each questionnaire and was classified as low anxiety (1st-23th percentile), moderate anxiety (25th75th percentile) and high anxiety (77th-99th percentile).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Syndrome', 'Emotional Stress']}, 'descriptionModule': {'briefSummary': 'This study aim to explore the impact of Jing Si Herbal Tea on pain and emotional stress in peripheral blood stem cell donors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* health Men or women aged 20 to 55 years old\n* willing to take Jing Si Herbal Drink\n\nExclusion Criteria:\n\n* no willing to take Jing Si Herbal Drink;\n* Previously already take Jing Si Herbal Drink daily'}, 'identificationModule': {'nctId': 'NCT06141902', 'briefTitle': 'The Effects of Jing Si Herbal Tea on Physical and Psychological Symptoms in Peripheral Blood Hematopoietic Stem Cell Donors', 'organization': {'class': 'OTHER', 'fullName': 'Buddhist Tzu Chi General Hospital'}, 'officialTitle': 'The Effects of Jing Si Herbal Tea on Physical and Psychological Symptoms in Peripheral Blood Hematopoietic Stem Cell Donors', 'orgStudyIdInfo': {'id': 'IRB111-125-A'}, 'secondaryIdInfos': [{'id': 'IMAR-111-01-17', 'type': 'OTHER_GRANT', 'domain': 'BuddhistTCGH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'NORMAL', 'description': 'daily diet', 'interventionNames': ['Other: Jing Si Herbal Drink']}, {'type': 'NO_INTERVENTION', 'label': 'Take Jing Si Herbal Drink', 'description': 'Take Jing Si Herbal Drink daily'}], 'interventions': [{'name': 'Jing Si Herbal Drink', 'type': 'OTHER', 'description': 'Jing Si Herbal Drink', 'armGroupLabels': ['NORMAL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '970', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Hualiien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buddhist Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}