Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-24 @ 11:07 PM
Study NCT ID:
NCT06857734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-04
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic and Anti-inflamatory Effect of Vit. B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014803', 'term': 'Vitamin B Complex'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D014815', 'term': 'Vitamins'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total dose of analgesics required postoperatively', 'timeFrame': 'within the first 24 hours and the time to first request'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain, Acute']}, 'descriptionModule': {'briefSummary': 'Vitamin C, also known as ascorbic acid, is a potent reducing agent and antioxidant that plays a crucial role in various metabolic processes.Vitamin B complex, a group of eight essential B vitamins, plays a crucial role in cellular metabolism, energy production, and maintaining nervous system health. There are few available studies on the effects of vitamin B injection on plasma inflammatory markers and its adjuvant analgesic effect along with the routine multimodal analgesia. Considering limited research and existing controversies in this field, the aim of present study is to evaluate the effects of preoperative and intraoperative vitamin B12 administration compared to vitamin C when used as a component of the multimodal analgesic technique in patients undergoing laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age 18-60 years)\n* American Society of Anesthesiologists (ASA) classification I-II\n* Patients undergoing laparoscopic cholecystectomy under general anaesthesia\n\nExclusion Criteria:\n\n* Hypersensitivity to vitamin B complex or vitamin C\n* History of chronic pain or use of opioids within the last month\n* Patient with inflammatory conditions\n* Severe renal or hepatic impairment\n* Patient with intellectual disabilities.'}, 'identificationModule': {'nctId': 'NCT06857734', 'acronym': 'vit B/vit C', 'briefTitle': 'Analgesic and Anti-inflamatory Effect of Vit. B', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'The Analgesic and Anti-inflamatory Effect of Vitamin B Versus Vitamin C Infusion in Patients Undergoing Laparoscopic Cholecystectomy ; a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Ms 33-12-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Drug: Vitamin B Complex']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'interventionNames': ['Drug: vitamin C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group N', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin B Complex', 'type': 'DRUG', 'description': 'group of vit. B will recieve as an oral capsules for 4 days preoperative , and infusion of vitamin B complex 1ml diluted in 100 ml normal saline administered intravenously after anathesia induction .', 'armGroupLabels': ['Group B']}, {'name': 'vitamin C', 'type': 'DRUG', 'description': 'group of vitamin C will recieve 1000 mg as an oral capsule for 4 days and infusion at dose of 50 mg/kg diluted in 100 ml normal saline administered iv after induction of anathesia .', 'armGroupLabels': ['Group C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'patients will recieve placebo tablets with identical regimen preoperative and a placebo infusion of 100 ml normal saline after induction of anathesia ,prepared with identical appearance and taste by the pharmacist according to the randomization group.', 'armGroupLabels': ['Group N']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banhā', 'country': 'Egypt', 'contacts': [{'name': 'Benha university', 'role': 'CONTACT', 'email': 'info@bu.edu.eg', 'phone': '+20133231011'}], 'facility': 'Benha university', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Islam M Hosainy, Master', 'role': 'CONTACT', 'email': 'islammoawad229@gmail.com', 'phone': '+201287466883'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Islam Moawad', 'investigatorAffiliation': 'Benha University'}}}}