Ignite Creation Date:
2025-12-24 @ 2:21 PM
Ignite Modification Date:
2026-01-01 @ 8:05 AM
Study NCT ID:
NCT07190495
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713927', 'term': 'ginger extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-09-14', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative nausea and vomiting (PONV) within 2 hours post-surgery', 'timeFrame': '2 hours after surgery.', 'description': 'Occurrence of at least one episode of nausea or vomiting within the first 2 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Recurrence of PONV beyond 2 hours postoperatively', 'timeFrame': 'From 2 hours to 24 hours after surgery.', 'description': 'Proportion of participants who experienced at least one additional episode of nausea or vomiting occurring after the 2-hour postoperative time point.'}, {'measure': 'Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery', 'timeFrame': '24 hours after surgery.', 'description': 'Occurrence of at least one episode of nausea or vomiting within the first 24 hours after surgery.'}, {'measure': 'Total number of vomiting episodes', 'timeFrame': 'Within 24 hours post-surgery.', 'description': 'Cumulative number of vomiting episodes recorded per participant during the first 24 hours after surgery.'}, {'measure': 'Use of rescue antiemetics', 'timeFrame': '24 hours postoperatively', 'description': 'The need for rescue antiemetics within 24 hours postoperatively.'}, {'measure': 'Incidence of ginger-related adverse events', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Number of participants experiencing adverse events known to be associated with ginger, including gastrointestinal discomfort (heartburn, abdominal pain, bloating, diarrhea), bleeding, or allergic reactions in the 24 hours after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ginger', 'Postoperative Nausea and Vomiting', 'Laparoscopic Cholecystectomy'], 'conditions': ['Postoperative Nausea and Vomiting', 'Laparoscopic Cholecystectomy']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate whether preoperative oral administration of ginger (800 mg, given 2 hours before surgery) reduces the incidence and severity of postoperative nausea and vomiting (PONV) within the first 24 hours after laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Scheduled for elective laparoscopic cholecystectomy under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to ginger\n* Documented history of bleeding disorders or current treatment with anticoagulant agents\n* History of severe postoperative nausea and vomiting or an Apfel score of 4\n* Administration of antiemetic drugs or corticosteroids during the preoperative period\n* Pregnancy or breastfeeding\n* Active gastrointestinal or liver disease'}, 'identificationModule': {'nctId': 'NCT07190495', 'acronym': 'GINGER-PONV', 'briefTitle': 'Ginger to Prevent Nausea and Vomiting After Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Preoperative Ginger for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Double-Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GINGER PONV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ginger group', 'description': 'Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy', 'interventionNames': ['Drug: Ginger']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ginger', 'type': 'DRUG', 'description': 'Patients will receive 800 mg of oral ginger 2 hours before laparoscopic cholecystectomy', 'armGroupLabels': ['Ginger group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will receive an oral placebo capsule identical in appearance to ginger, administered 2 hours before laparoscopic cholecystectomy', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Nabeul', 'state': 'Nabeul Governorate', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Ibtissem BEN TALEB, M.D.', 'role': 'CONTACT', 'email': 'ibtissem.bentaleb@fmt.utm.tn', 'phone': '+216 23 133 748'}, {'name': 'Mechaal BEN ALI, M.D.', 'role': 'CONTACT', 'email': 'mechaal_benali@yahoo.fr', 'phone': '+216 98 657 034'}], 'facility': 'Mohamed Taher Maamouri University Hospital', 'geoPoint': {'lat': 36.45606, 'lon': 10.73763}}], 'centralContacts': [{'name': 'Ibtissem BEN TALEB, M.D.', 'role': 'CONTACT', 'email': 'ibtissem.bentaleb@fmt.utm.tn', 'phone': '+216 23 133 748'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Anesthesiology and Intensive Care', 'investigatorFullName': 'Ben Taleb Ibtissem', 'investigatorAffiliation': 'University Tunis El Manar'}}}}