Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-11 @ 2:29 PM
Study NCT ID:
NCT05915520
Status:
UNKNOWN
Last Update Posted:
2023-06-23
First Post:
2023-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Baduanjin Program Effect on Geriatric Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2023-06-13', 'studyFirstSubmitQcDate': '2023-06-13', 'lastUpdatePostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cortisol', 'timeFrame': 'It will be measured after 8 weeks', 'description': 'it is a serum stress marker'}], 'secondaryOutcomes': [{'measure': 'depression sub component of Hospital anxiety and depression scale', 'timeFrame': 'It will be measured after 8 weeks', 'description': 'It will be measure depression'}, {'measure': 'anxiety sub component of Hospital anxiety and depression scale', 'timeFrame': 'It will be measured after 8 weeks', 'description': 'It will be measure anxiety'}, {'measure': 'Glasgow dyspepsia severity score', 'timeFrame': 'It will be measured after 8 weeks', 'description': 'It will be used to assess functional dyspepsia'}, {'measure': 'visual analogue scale', 'timeFrame': 'It will be measured after 8 weeks', 'description': 'It will be used to assess abdominal symptoms of geriatric patients regarding functional dyspepsia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Dyspepsia']}, 'descriptionModule': {'briefSummary': 'functional dyspepsia is very common between geriatric population', 'detailedDescription': 'Forty Egyptian geriatrics with functional dyspepsia, after randomization, will be divided to 2 groups; the first 20-geriatric group will receive 5-session per-week 40-minute baduinjuin for 8 weeks plus the daily dose of pantoprazole (40 mg orally administered tablet drug. in the other 20-geriatric group, the daily dose of drug will be administered only for 8 weeks .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'genderBased': True, 'genderDescription': 'self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* functional dyspepsia complaints\n* geriatric population\n\nExclusion Criteria:\n\n* cardiac complaints\n* respiratory complaints\n* articular complaints'}, 'identificationModule': {'nctId': 'NCT05915520', 'briefTitle': 'Baduanjin Program Effect on Geriatric Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Baduanjin Program Effect on Geriatric Functional Dyspepsia', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004557'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'the 20-geriatric group will receive 5-session per-week 40-minute baduinjuin for 8 weeks plus the daily dose of pantoprazole (40 mg orally administered tablet drug)', 'interventionNames': ['Behavioral: baduinjuin activities']}, {'type': 'OTHER', 'label': 'group B', 'description': 'this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks .', 'interventionNames': ['Other: pantoprazole']}], 'interventions': [{'name': 'baduinjuin activities', 'type': 'BEHAVIORAL', 'description': 'in this 20-geriatric group will receive 5-session per-week 40-minute baduinjuin for 8 weeks plus the daily dose of pantoprazole (40 mg orally administered tablet drug)', 'armGroupLabels': ['group A']}, {'name': 'pantoprazole', 'type': 'OTHER', 'description': 'in this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks .', 'armGroupLabels': ['group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ali Ismail, lecturer', 'role': 'CONTACT', 'email': 'allooka2012@gmail.com', 'phone': '01005154209'}], 'facility': 'Cairo Unoversity', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Ali MA Ismail', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '01005154209'}, {'name': 'Ali MA Ismail, lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg'}], 'overallOfficials': [{'name': 'Ali MA Ismail', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy for Internal Medicine and Geriatrics', 'investigatorFullName': 'Ali Mohamed Ali ismail', 'investigatorAffiliation': 'Cairo University'}}}}