Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-09 @ 7:07 AM
Study NCT ID:
NCT00985335
Status:
COMPLETED
Last Update Posted:
2011-11-18
First Post:
2009-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-16', 'studyFirstSubmitDate': '2009-08-28', 'studyFirstSubmitQcDate': '2009-09-25', 'lastUpdatePostDateStruct': {'date': '2011-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cold Sore Symptom Scale', 'timeFrame': 'Baseline and End of Treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Herpes Simplex']}, 'descriptionModule': {'briefSummary': 'This study intends to test the efficacy of the TheraNeem Lip Therapy balm for Herpes Simplex. The study will include a total of 5 people.', 'detailedDescription': 'Qualified candidates will be officially enrolled into the study within 24 hours of their subsequent outbreak of Herpes Simplex Labialis. They will be given all of the Neem Therapy products to use, and photographs and questionnaires will be taken to assess their progress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant has signs and symptoms of HSV-1 infection of less than 24 hours duration to the Southern California University of Health Sciences investigators\n2. Participants ages 18-70 years\n3. Confirmation of oral-circumoral herpes lesion will be made by a clinician in the presence of oral-circumoral lesion assumed to be HSV-1 for purposes of study\n4. Subjects expressed willingness to comply with protocol\n5. Subject will be willing to have the presenting lesion photographed twice\n6. Subject sign a written informed consent, HIPPA disclosure, Experimental bill of rights\n\nExclusion Criteria:\n\n1. History of past or present immunosuppressive condition, or currently taking immunosuppressive medication\n2. History of adverse effects or allergies to any Neem based product or containing any of the other ingredients TheraNeem Lip Therapy: Organic Coconut Oil, Organic Beeswax, Organic Jojoba Oil, Shea Butter, Sesame Oil, Organic Neem Oil, , Essential Oil of Peppermint, Vitamin E (Tocopherol)\n3. Signs of disseminated HSV illness\n4. History of use of oral or topical antiviral agents within 10 days of screening and/or at start of study visit\n5. Pregnancy or lactation\n6. Psychiatric disorder\n7. Inability to understand or follow the instructions'}, 'identificationModule': {'nctId': 'NCT00985335', 'acronym': 'Neem', 'briefTitle': 'Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis', 'organization': {'class': 'OTHER', 'fullName': 'Southern California University of Health Sciences'}, 'officialTitle': 'Effectiveness of TheraNeem Lip Therapy of Common Symptoms of Herpes Simplex Labialis A Prospective Experimental Case Series (n=5)', 'orgStudyIdInfo': {'id': 'SCU-09-VINJ004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'External Application of Neem-based Cream', 'description': 'Non Controlled, non-randomized, single group pilot study.', 'interventionNames': ['Other: Neem Based External Application Cream']}], 'interventions': [{'name': 'Neem Based External Application Cream', 'type': 'OTHER', 'description': 'Apply externally 3-4 times per day', 'armGroupLabels': ['External Application of Neem-based Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90604', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Southern California University of Health Science', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}], 'overallOfficials': [{'name': 'Melany Meier, DC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern California University of Health Sciences'}, {'name': 'Sivarama Vinjamury, L.Ac', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern California University of Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern California University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sivarama Vinjamury', 'investigatorAffiliation': 'Southern California University of Health Sciences'}}}}