Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-02 @ 10:33 AM
Study NCT ID:
NCT06628804
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-09
First Post:
2024-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artemisia and Green Tea Extracts for Gastric Mucosal Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-04', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Korean version of the Gastrointestinal Symptom Rating Scale: Total score', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks. This is a 4-point Likert scale for each of the 15 items, with scores ranging from 0 to 3. A score of 0 indicates no symptoms, and 3 represents very severe symptoms. The higher the overall score, the more severe the gastrointestinal symptoms. The minimum value was 0, and the maximum value was 45, and higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'The Korean version of the Gastrointestinal Symptom Rating Scale: Subtotal scores of upper abdomen', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks. This is a 4-point Likert scale for each of the 8 items, with scores ranging from 0 to 3. A score of 0 indicates no symptoms, and 3 represents very severe symptoms. The higher the overall score, the more severe the gastrointestinal symptoms. The minimum value was 0, and the maximum value was 21, and higher scores mean a worse outcome.'}, {'measure': 'Visual Analogue Scale for evaluating gastric mucosal improvement', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 100, and higher scores mean a worse outcome.'}, {'measure': 'Gastrointestinal symptom score', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 40, and higher scores mean a worse outcome. For each gastrointestinal symptom, the minimum value was 0, and the maximum value was 4, and higher scores mean a worse outcome.'}, {'measure': "Patient's global assessment score", 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks. The 5-point Likert scale for the Patient\'s Global Assessment Score is a self-reported tool where patients rate their disease activity. It uses an order scale, with 5 indicating "Very Good" and 1 indicating "Poor." The patient evaluates their condition based on this scale: Very Good-Good-Fair-Unchanged-Poor.'}, {'measure': 'Pepsinogen I level (ng/mL)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks'}, {'measure': 'Pepsinogen II level (ng/mL)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks'}, {'measure': 'Pepsinogen I/Pepsinogen II ratio', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks'}, {'measure': 'Gastrin-17 level (ng/L)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks'}, {'measure': 'Helicobacter pylori IgG titer (units)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks'}, {'measure': 'High-sensitive C-reactive protein (mg/dL)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Measured at baseline and 8 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Dysphonia']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to determine whether Artemisia and green tea extracts promote gastric mucosal health in adults with functional dyspepsia and to assess its safety.\n\nThe main questions are:\n\n* Does Artemisia and green tea extracts promote gastric mucosal health in participants?\n* What side effects occur when participants take Artemisia and green tea extracts?', 'detailedDescription': 'Researchers will compare Artemisia and green tea extracts to placebo to evaluate their effectiveness in promoting gastric mucosal health.\n\nParticipants will:\n\n* Take Artemisia and green tea extracts or a placebo daily for 8 weeks.\n* Visit the clinic every 4 weeks for checkups and tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rome IV-based functional dyspepsia-\n\nExclusion Criteria:\n\n* Patients with gastrointestinal symptoms requiring immediate drug treatment.\n* Individuals with a history of hypersecretory gastric disorders like Zollinger-Ellison syndrome.\n* Individuals who received Helicobacter pylori eradication therapy within 4 weeks prior to the trial.\n* Individuals who have taken nonsteroidal anti-inflammatory drugs, steroids, antibiotics, aspirin, antithrombotic agents, or acid suppressants within the last month.\n* Individuals with a history of upper gastrointestinal surgery, stricture, bleeding, or procedures like esophageal dilation or mucosal resection within the last year.\n* Individuals with gastric ulcers (active or healing), duodenal ulcers (active or healing), reflux esophagitis (LA grade A or higher), or malignant tumors identified within the last 6 months through endoscopy.\n* Patients with uncontrolled hypertension (resting BP ≥160/100 mmHg).\n* Patients with uncontrolled diabetes (fasting glucose ≥160 mg/dL).\n* Individuals with creatinine levels ≥ 2 times the upper limit of normal at the research institution.\n* Individuals with aspartate aminotransferase or alanine aminotransferase levels ≥ 2 times the upper limit of normal at the research institution.\n* Alcohol abusers.\n* Individuals taking medications for psychiatric disorders (except those taking intermittent medication for sleep disorders).\n* Pregnant or breastfeeding women or those planning to become pregnant during the clinical trial period.\n* Individuals with allergies to any components of the study foods.\n* Individuals who participated in or plan to participate in another drug clinical trial within the last month.\n* Individuals deemed unsuitable for the study by the investigator for other reasons.'}, 'identificationModule': {'nctId': 'NCT06628804', 'briefTitle': 'Artemisia and Green Tea Extracts for Gastric Mucosal Health', 'organization': {'class': 'OTHER', 'fullName': 'Pusan National University Yangsan Hospital'}, 'officialTitle': 'Effects of Artemisia and Green Tea Extracts on Promoting Gastric Mucosal Health in Adults with Functional Dyspepsia: a Randomized, Double-blind, Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': '12-2024-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Artemisia and green tea extracts group', 'description': 'This group takes Artemisia and green tea extracts for 8 weeks.', 'interventionNames': ['Dietary Supplement: Artemisia and green tea extracts']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'This group takes a placebo for 8 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Artemisia and green tea extracts', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Artemisia and green tea extracts 700 mg/day for 8 weeks', 'armGroupLabels': ['Artemisia and green tea extracts group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo 700 mg/day for 8 weeks', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50612', 'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'overallOfficials': [{'name': 'Sang Yeoup Lee, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sang Yeoup Lee', 'investigatorAffiliation': 'Pusan National University Yangsan Hospital'}}}}