Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-31 @ 12:02 PM
Study NCT ID:
NCT06886035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-03-14', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the visual analogue scale (VAS)', 'timeFrame': '24 hours after surgery', 'description': 'The primary goal was to assess the variation in postoperative pain levels recorded on the VAS (scored from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable) 24 hours after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Care', 'Pain Management']}, 'referencesModule': {'references': [{'pmid': '34986477', 'type': 'BACKGROUND', 'citation': 'Ariyasriwatana C, Phoolcharoen N, Oranratanaphan S, Worasethsin P. Efficacy of Curcuminoids in Managing Postoperative Pain after Total Laparoscopic Hysterectomy: A Randomized Controlled, Open-Label Trial. Complement Med Res. 2022;29(3):223-227. doi: 10.1159/000521669. Epub 2022 Jan 5.'}, {'pmid': '25520223', 'type': 'BACKGROUND', 'citation': 'Nurullahoglu KE, Okudan N, Belviranli M, Oz M. The comparison of preemptive analgesic effects of curcumin and diclofenac. Bratisl Lek Listy. 2014;115(12):757-60. doi: 10.4149/bll_2014_146.'}]}, 'descriptionModule': {'briefSummary': 'Total hysterectomy is one of the most common surgical procedures in gynecology. Total laparoscopic hysterectomy (TLH) has several advantages over open surgery, such as better cosmetic outcomes, faster recovery, and an earlier return to normal activities and work, and has thus become the preferred approach Nonetheless, postoperative pain (PP) remains an issue of concern.\n\nThe reported incidence of PP after TLH ranges from 35 % to 63 %. The origin of PP after laparoscopy is multifactorial, arising from several perioperative factors, including pneumoperitoneum, stretching of the intraabdominal cavity, blood left in the abdomen, and dissection of the pelvic region. A prospective trial found more intense pain and greater analgesia requirement in the immediate postoperative period associated with laparoscopic surgery than with laparotomy. Methods to decrease the severity of PP are required before TLH can be confidently recommended.\n\nCurcumin has several benefits, which are endorsed by the World Health Organization (WHO).\n\nThat is, it can be used to treat dyspepsia and peptic ulcer. Moreover, it has anti-inflammatory and analgesic properties. Most benefits are attributed to its anti-oxidant and anti-inflammatory effects. Curcuminoid is the active ingredient of turmeric. Curcuminoids are used in laparoscopic surgery because of their aforementioned benefits. Further, the use of traditional medicine, which is low-cost and effective in improving postoperative pain due to abdominal diştention, is assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Laparoscopic total hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, trans obturator tape insertion, or sentinel lymphadenectomy candidates\n\n* They should be able to understand and sign an informed consent\n* They should be literate enough to understand the maintenance of a diary recording pain scores, QoL-15 scores, and any adverse event\n\nExclusion Criteria:\n\n* Patients with any peripheral or central neuropathic pain\n\n * Patients used to taking over-the-counter painkiller pills\n * Patients with a history of alcohol intake/drug dependence\n * Patients with a history of psychosis\n\n \\*Patients with chronic inflammatory diseases who cannot be taken off nonsteroidal anti-inflammatory drugs (NSAIDs)/painkillers\n * Patients on immunosuppressive/cytotoxic/steroid therapy. \\*Patients with a known allergy to duloxetine'}, 'identificationModule': {'nctId': 'NCT06886035', 'briefTitle': 'Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Erzincan Military Hospital'}, 'officialTitle': 'Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy', 'orgStudyIdInfo': {'id': 'M07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Our clinical ERAS (Enhanced Recovery After Surgery) protocols were implemented to control patients without any additional intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Our clinical ERAS (Enhanced Recovery After Surgery) protocols were implemented to study patients. The study group also began a regimen of 100 mg oral liposomal curcumin (administered as 50 mg twice daily) one day before the procedure. Following surgery, oral liposomal curcumin (50 mg twice daily) was restarted 8 hours postoperatively and maintained for an additional two days.', 'interventionNames': ['Drug: liposomal curcumin']}], 'interventions': [{'name': 'liposomal curcumin', 'type': 'DRUG', 'description': 'The study group began a regimen of 100 mg oral liposomal curcumin (administered as 50 mg twice daily) one day prior to the procedure. Following surgery, oral liposomal curcumin (50 mg twice daily) was restarted 8 hours postoperatively and maintained for an additional two days. ( A total dose 300 mg)', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kemal Güngördük, MD, PROF.', 'role': 'CONTACT', 'email': 'drkemalgungorduk@gmail.com', 'phone': '+905054921766'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzincan Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof dr', 'investigatorFullName': 'Kemal GUNGORDUK', 'investigatorAffiliation': 'Erzincan Military Hospital'}}}}