Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-28 @ 4:29 AM
Study NCT ID:
NCT05885906
Status:
UNKNOWN
Last Update Posted:
2023-09-14
First Post:
2023-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in unstimulated Salivary flow rate', 'timeFrame': 'Baseline, 2weeks and 4weeks', 'description': 'Milliliters'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Xerostomia', 'Aloevera', 'Thyme honey', 'type 2 diabetes'], 'conditions': ['Xerostomia']}, 'descriptionModule': {'briefSummary': 'The objectives of the present study are to:\n\n1. Compare the clinical efficacy of (50%) aloe vera versus (20%) thyme honey mouthwash on management of xerostomia in diabetic patients by measuring the salivary flow rate as a primary objective.\n2. Asses the biochemical effect of aloe vera and thyme honey on the level of salivary nitric oxide, xerostomia grade as well as patient quality of life as a secondary objective.\n\nResearch question:\n\nWhich is better aloe vera or thyme honey in improving salivary flow rate in diabetic patients suffering from xerostomia?\n\nPatient Grouping and Randomization:\n\nPatients with xerostomia will be randomly distributed into three groups using a computer-generated randomization table. Allocation concealment will be achieved by a sealed opaque envelope with a ratio of 1:1:1\n\nGroup 1 (Aloe Vera group)\n\nInclude (15) patient suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash\n\nGroup 2 (Thyme honey group):\n\nInclude (15) patient suffering from diabetes induced xerostomia that will receive thyme honey mouthwash\n\nGroup 3 (Saline control group):\n\nInclude (15) patient suffering from diabetes induced xerostomia that will receive saline mouthwash', 'detailedDescription': 'Saliva is a complex mix from major as well as minor salivary glands and gingival crevicular fluids. It is a clear and slightly acidic diluted secretion with more than 99% water, electrolytes, immunoglobulins, enzymes, proteins, mucin and nitrogenous products. Subjective feeling of a dry mouth is known as xerostomia, which may result from diminished saliva production, but some people reported feeling a dry mouth even though there was no decrease in saliva quantity.Diabetes mellitus is considered one of the main causes of xerostomia There are different treatments modalities of xerostomia which include pharmacological and non-pharmacological treatments.Recently different herbs were used in the treatment of xerostomia and showed promising results and great patient acceptance among which aloe vera and thyme honey are used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Both gender, with type 2 diabetes mellitus only and suffering from xerostomia.\n2. Patients willing to follow all the instructions and attend all the study-associated visits.\n\nExclusion Criteria:\n\n1. Patients who had received radiation therapy to the head and neck region.\n2. Patients with other systemic diseases known to cause xerostomia (Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, hepatitis C virus, tuberculosis, or sarcoidosis).\n3. Patients using any other medication for their dry mouth condition (pilocarpine, cevimeline) 7 days before entering into the study.\n4. Patients requiring hospitalization for any medical problem during the study.\n5. Known hypersensitivity to the active ingredient of the product that will be used as assessed by the medical history questionnaire.\n6. Vulnerable groups such as mentally or physically handicapped individuals, pregnant females, prisoners."}, 'identificationModule': {'nctId': 'NCT05885906', 'briefTitle': 'Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Aloe Vera Versus Thyme Honey Mouthwash in Management of Xerostomia in Type 2 Diabetics (A Randomized Controlled Clinical Trial With Biochemical Analysis)', 'orgStudyIdInfo': {'id': 'FDASU-RecIM122208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aloevera group', 'description': '15 patients suffering from diabetes induced xerostomia that will receive aloe vera as mouthwash (20 ml of aloe vera 50%) 3 times per day for 4 weeks.', 'interventionNames': ['Drug: Aloevera']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thyme honey group', 'description': '15 patients suffering from diabetes induced xerostomia that will receive thyme honey mouthwash (20 ml of thyme honey diluted in 100 ml of distilled water) 3 times per day for 4 weeks.', 'interventionNames': ['Drug: Thyme honey']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline group', 'description': '15 patients suffering from diabetes induced xerostomia that will receive saline mouthwash as a control group (20 ml of saline) 3 times per day for 4 weeks.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Aloevera', 'type': 'DRUG', 'description': 'Mouthwash', 'armGroupLabels': ['Aloevera group']}, {'name': 'Thyme honey', 'type': 'DRUG', 'description': 'Mouthwash', 'armGroupLabels': ['Thyme honey group']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Mouthwash', 'armGroupLabels': ['Saline group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of dentistry Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Radwa Rageb, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Dina Borham Abdelhafez Abdellatif Elkhouly', 'investigatorAffiliation': 'Ain Shams University'}}}}