Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT04118335
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2019-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mulberry Syrup on Oral Mucositis Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2019-10-04', 'lastUpdatePostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of oral mucositis healing', 'timeFrame': 'Change from oral mucositis healing levels at 15 days', 'description': 'Oral mucosa of patients were evaluated with The Oral Evaluation Guide by examining the patients mucous membrane with the help of light source and asking patients.\n\nOral Evaluation Guide: The guideline evaluates the changes of the oral mucosa in eight areas. In the evaluation of the guide, numerical expressions like 1, 2, 3 are used and the changes in voice, swallowing function, saliva, tongue, lips, mucous membranes, gums, teeth or prostheses are scored. When scoring, all scores from eight areas are collected and the Oral Mucosal Score (OMS) is calculated. The lowest possible score is 8 and the highest score is 24. As the score increases, intra-oral complaints and the severity of mucositis increase.'}], 'secondaryOutcomes': [{'measure': 'Severity of oral mucositis', 'timeFrame': 'Change from severity of oral mucositis at 15 days', 'description': 'Severity of oral mucositis were evaluated with World Health Organization Oral Mucositis Scoring Index by examining the patients mucous membrane with the help of light source and asking patients.\n\nWorld Health Organization Oral Mucositis Scoring Index: According to this index, the severity of oral mucositis is graded as grade 0; no mucositis, grade 1; mild, grade 2; moderate, grade 3-4; severe mucositis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral mucositis in COPD patients', 'complementary therapies', 'nursing interventions', 'oral care with black mulberry syrup'], 'conditions': ['Oral Mucositis']}, 'descriptionModule': {'briefSummary': 'Objective: This study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD.\n\nStudy Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.', 'detailedDescription': 'Objective: This mix study was carried out to investigate the effectiveness of oral care with black mulberry syrup on oral mucositis healing in individuals with COPD.\n\nStudy Design: The quantitative part of the study was conducted as a randomized controlled experimental study, the qualitative section was conducted by in-depth interview method. Approval from the Ethics Committee and written permission from the institution were obtained. After the participants were informed about the purpose of the study, their written consents were obtained. The study was performed with 40 patients who were hospitalized in the Chest Diseases Clinic. In addition to the standard practice of the clinic, the individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it. They did this application 3 times a day after meals. 10 individuals in the intervention group were interviewed by using a semi-structured interview form.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years of age,\n* no visual or hearing problem,\n* unimpaired time and place orientation,\n* no psychiatric disorders,\n* diagnosed with COPD,\n* oral mucositis developed,\n* used Nystatin and/or Benzidamine Hydrochloride therapy\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04118335', 'briefTitle': 'Mulberry Syrup on Oral Mucositis Healing', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'The Effect of Oral Care by Black Mulberry Syrup on Oral Mucositis in Individuals With COPD', 'orgStudyIdInfo': {'id': '2017/42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The individuals in the intervention group were asked to gargle with 5 ml black mulberry syrup three times a day after meals and wait average one minute in the mouth and then swallow, in addition to the standard practice of the clinic. According to the standard practice of the clinic, mucositis treatment was performed by nystatin and/or benzidamine hydrochloride to the patients with the request of the physician. The patients were followed for 15 days. The 15-day period is consistent with the duration of mucositis healing in the literature. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday.', 'interventionNames': ['Other: Black Mulberry Syrup']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Standard procedures of the clinic were applied to control group. According to the standard practice of the clinic, mucositis treatment was performed by nystatin and/or benzidamine hydrochloride to the patients with the request of the physician. Follow-up and evaluation of patients who were discharged early were performed by home visits and made a phone call everyday.'}], 'interventions': [{'name': 'Black Mulberry Syrup', 'type': 'OTHER', 'description': 'The individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Sevda Korkut, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TC Erciyes University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sevda Korkut', 'investigatorAffiliation': 'TC Erciyes University'}}}}