Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT01429935
Status:
UNKNOWN
Last Update Posted:
2011-09-07
First Post:
2011-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti Inflammatory and Analgesic Effect of Ginger Powder in Dental Pain Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-12-21', 'releaseDate': '2011-11-20'}, {'resetDate': '2014-08-25', 'releaseDate': '2014-08-10'}], 'estimatedResultsFirstSubmitDate': '2011-11-20'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-06', 'studyFirstSubmitDate': '2011-09-04', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased amount of cheek swelling after surgery', 'timeFrame': '5 days', 'description': 'Using standard calipers, cheek thickness will be measured from the lingual aspect of the mid-portion of the crown of the mandibular 1st molar (on the same side) to the tangent of the skin of the cheek.'}], 'secondaryOutcomes': [{'measure': 'Decreased amount of serum CRP levels', 'timeFrame': '3 days', 'description': 'A venous blood sample (approximately 4 ml, 2ml for CBC check up and 2 ml for CRP concentration) will be collected to quantitatively assess the CRP concentration after surgery and the second sample will be collected 72 hours postoperatively'}, {'measure': 'Amount of pain severity', 'timeFrame': '5 days', 'description': 'using 100mmVAS scale,at 1 hour intervals in the first 12 hours following the surgery and every 6 hours until day 5.'}, {'measure': 'Increased amount of Mouth opening ability', 'timeFrame': '5 days', 'description': 'assessed by measuring the distance between the upper and lower central incisal edges at maximal mouth opening on days 0 (baseline) and 1,3 and 5 post operatively.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dental pain model', 'Ginger powder', 'CRP'], 'conditions': ['Impacted Third Molar Tooth']}, 'descriptionModule': {'briefSummary': 'Ginger contains constituents with pharmacological properties similar to the novel class of dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer side effects than conventional NSAIDs and now are being investigated as a novel class of anti-inflammatory compounds. Although ginger has potentially strong anti-inflammatory components, its efficacy on acute inflammation was not assessed before. The common postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling, related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several clinical trials. However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an effective, oral analgesic with a more favorable safety profile. The primary aim of this study was to investigate the ability of Ginger powder (Zintoma, Goldaru) to reduce postoperative swelling, pain and trismus in an acute pain model.', 'detailedDescription': 'Ginger, the rhizome of Zingiber officinale, has a long history of medicinal use. In traditional Chinese and Indian medicine, ginger has been used to treat a wide range of ailments including stomachache, diarrhea, nausea, asthma, respiratory disorders, toothache, gingivitis, and arthritis. Subsequent studies revealed that ginger contains constituents with pharmacological properties similar to the novel class of dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer side effects than conventional NSAIDs and now are being investigated as a novel class of anti-inflammatory compounds. Different animal studies revealed that oral dried ginger or ginger extract reduced inflammation in paw and joint swelling induced by different chemical agents, lung inflammation induced by lipopolysaccharides (LPS) and arthritis induced by collagen . Several clinical studies support the value of ginger for the treatment of osteoarthritis . In addition to alleviating pain, ginger extract has been reported to decrease joint swelling. In some of these trials it was reported that ginger relieved pain and swelling to varying degrees in patients with osteoarthritis and rheumatoid arthritis as well as those with muscular pain without causing any adverse effects during a period ranging from 3 months to 2.5 years . In one recent trial ginger was tested in primary dysmenorrhea in comparison with Ibuprofen and mefenamic acid and no significant differences was found between the three study groups in relief, stability, or aggravation of symptoms . The common postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling, related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several clinical trials . However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an effective, oral analgesic with a more favorable safety profile. The primary aim of this study was to investigate the ability of Ginger powder (Zintoma, Goldaru,Iran) to reduce postoperative swelling, pain and trismus after third molar surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have at least one mesio-angular impacted mandibular third molar(5-7 difficulty degree)\n* adults without any kind of systemic disease\n* adults with at least Diploma educational degree\n\nExclusion Criteria:\n\n* history of cold,fever,infection or any other inflammatory conditions during one month before surgery\n* known allergy to NSAIDs ,ginger or acetaminophen\n* any kind of hematopoietic or bleeding disorders\n* pregnancy or lactating\n* history of peptic ulceration\n* history of corticosteroid use\n* duration of surgery more than 30 minutes\n* any infection, fever or any kind of disease cause on days 1,2 and 3 after surgery\n* failure to attend for follow up\n* using any kind of medication other than given drugs until day 5 post operatively\n* being on anticoagulants except for mini-aspirin (72-325 mg/day)\n* mentally incapable of understanding or complying with the study protocol or for failing to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT01429935', 'acronym': 'GPE', 'briefTitle': 'Anti Inflammatory and Analgesic Effect of Ginger Powder in Dental Pain Model', 'organization': {'class': 'OTHER', 'fullName': 'Qazvin University Of Medical Sciences'}, 'officialTitle': 'Comparison of The Anti Inflammatory and Analgesic Effect of Ginger and Ibuprofen in Post Surgical Pain Model; a Randomized,Placebo-controlled,Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': '504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ginger powder', 'interventionNames': ['Drug: Ginger powder']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen', 'description': 'capsules of Ibuprofen 400 mg', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'capsules contain starch', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Ginger powder', 'type': 'DRUG', 'otherNames': ['zintoma'], 'description': 'capsules contain 500mg Ginger powder,every 6hours,for 5 days', 'armGroupLabels': ['Ginger powder']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': 'capsules of Ibuprofen 400 mg, every 6 hours for 5 days', 'armGroupLabels': ['Ibuprofen']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'capsules contain starch', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3415759811', 'city': 'Qazvin', 'state': 'Qazvin State', 'country': 'Iran', 'facility': 'Qazvin University of Medical Sciences', 'geoPoint': {'lat': 36.26877, 'lon': 50.0041}}, {'city': 'Qazvin', 'country': 'Iran', 'facility': 'University of Medical Science', 'geoPoint': {'lat': 36.26877, 'lon': 50.0041}}], 'overallOfficials': [{'name': 'Farshid Rayati, DDS,OMFS', 'role': 'STUDY_CHAIR', 'affiliation': 'Assisstant professor of oral and maxillofacial dapartment'}, {'name': 'Fateme Hajmanuchehri', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assisstant professor of general pathology department'}, {'name': 'Mehran Purghasemi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'General pharmacologist'}, {'name': 'Elnaz Najafi, DDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'General dentist'}, {'name': 'Farshid Rayati, DDS,OMFS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assisstant professor of oral and maxillofacial department'}, {'name': 'Elanaz Najafi, dentist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General dentist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qazvin University Of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant proffessor of oral and maxillofacial department', 'investigatorFullName': 'farshid rayati', 'investigatorAffiliation': 'Qazvin University Of Medical Sciences'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-11-20', 'type': 'RELEASE'}, {'date': '2011-12-21', 'type': 'RESET'}, {'date': '2014-08-10', 'type': 'RELEASE'}, {'date': '2014-08-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'farshid rayati, assisstant proffessor of oral and maxillofacial department, Qazvin University Of Medical Sciences'}}}}