Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-26 @ 1:20 PM
Study NCT ID:
NCT01356693
Status:
UNKNOWN
Last Update Posted:
2011-06-28
First Post:
2011-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-20', 'releaseDate': '2017-05-31'}], 'estimatedResultsFirstSubmitDate': '2017-05-31'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001963', 'term': 'Bromelains'}], 'ancestors': [{'id': 'D003546', 'term': 'Cysteine Endopeptidases'}, {'id': 'D057056', 'term': 'Cysteine Proteases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010450', 'term': 'Endopeptidases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-27', 'studyFirstSubmitDate': '2011-05-12', 'studyFirstSubmitQcDate': '2011-05-18', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in score in a cough evaluation questionnaire', 'timeFrame': 'before and 10 and 30 minutes after the dosing', 'description': 'A cough score based on number of coughing episodes and subjective 5 item cough score : no cough, mild, moderate, severe, very severe.'}], 'secondaryOutcomes': [{'measure': 'Change in Occurrence of gastric symptoms', 'timeFrame': '10 and 30 minutes', 'description': 'Question "YES" as answer to questions about gastric symptoms as nausea and/or vomiting after medication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cough', 'Common cold', 'Child', 'Adolescent'], 'conditions': ['Cough, Acute']}, 'referencesModule': {'references': [{'pmid': '18253996', 'type': 'BACKGROUND', 'citation': 'Smith SM, Schroeder K, Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001831. doi: 10.1002/14651858.CD001831.pub3.'}, {'pmid': '12008729', 'type': 'BACKGROUND', 'citation': 'Widdicombe J, Morice A. Over the counter cough medicines for acute cough. Good quality research is needed. BMJ. 2002 May 11;324(7346):1158. No abstract available.'}, {'pmid': '287010', 'type': 'BACKGROUND', 'citation': 'Gardner JF. Regulation of the threonine operon: tandem threonine and isoleucine codons in the control region and translational control of transcription termination. Proc Natl Acad Sci U S A. 1979 Apr;76(4):1706-10. doi: 10.1073/pnas.76.4.1706.'}, {'pmid': '27181342', 'type': 'DERIVED', 'citation': 'Peixoto DM, Rizzo JA, Schor D, Silva AR, Oliveira DC, Sole D, Sarinho E. Use of honey associated with Ananas comosus (Bromelin) in the treatment of acute irritative cough. Rev Paul Pediatr. 2016 Dec;34(4):412-417. doi: 10.1016/j.rpped.2016.03.006. Epub 2016 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'Cough is the most bothersome symptom for patients with the common cold.\n\nThe objective of the study is to compare the phytotherapic "Bromelin", a compound preparation of honey from the bee apis mellifera with the extract of the pineapple (Ananas comosus) with placebo in reducing cough episodes in patients with the common cold.', 'detailedDescription': 'Common cold is very frequent and cough is one of the most troublesome symptoms. Over-the-counter medications are used by patients without prescription, many times with important side effects.\n\nBromelin, a compound made with honey and pineapple extract could offer cough symptomatic relief as a soothing agent.\n\nThis study aims to compare this compound with placebo in reducing cough in patients with common cold in an clinical trial designed in conformity to CONSORT guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cough for less than 24 hours\n* common cold symptoms : nasal obstruction, headache, myalgias, runny nose.\n\nExclusion Criteria:\n\n* declared chronic pulmonary diseases declared Nervous diseases declared Diabetes declared cardiac diseases known primary or secondary immunodeficiencies'}, 'identificationModule': {'nctId': 'NCT01356693', 'acronym': 'BROMETOSS', 'briefTitle': 'Bromelin, a Compound Prepared With Ananas Comocus Extract and Honey, for Acute Cough', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'officialTitle': 'Randomized,Double-blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of the Phytotherapic Compound "Bromelin" on Acute Irritative Cough', 'orgStudyIdInfo': {'id': 'Brom1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active drug', 'description': 'Bromelin. Extract from Ananas comosus, 3,3g on vehicle (methylparaben, propylparaben, honey from apis mellifera, sodium benzoate, ethylic alcohol, water) 5ml.', 'interventionNames': ['Drug: Bromelin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparator with the same characteristics of experimental drug, 5ml, single dose.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bromelin', 'type': 'DRUG', 'otherNames': ['Bromelein', 'Ananas comosus extract'], 'description': 'Ananas comosus extract (3,3g) on vehicle: methylparaben, propylparaben, honey from Apis mellifera, sodium benzoate, ethilic alcohol, water) 5ml. Given in single dose.', 'armGroupLabels': ['Active drug']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo with mimicking characteristics of experimental drug', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50670-901', 'city': 'Recife', 'state': 'Pernambuco', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Emanuel S Sarinho, MD, PhD', 'role': 'CONTACT', 'email': 'emanuel.sarinho@gmail.com', 'phone': '55-81-88814801'}, {'name': 'Decio M Peixoto, MD, PhD', 'role': 'CONTACT', 'email': 'daph@elogica.com.br', 'phone': '55-81-86636709'}, {'name': 'Jose A Rizzo, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dinaldo C Oliveira, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Almerinda R silva, MD, MsC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital das Clínicas/UFPE', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'centralContacts': [{'name': 'Emanuel SC Sarinho, MD, PhD', 'role': 'CONTACT', 'email': 'emanuel.sarinho@gmail.com', 'phone': '55-81-88814801'}], 'overallOfficials': [{'name': 'Decio M Peixoto, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UFPE'}, {'name': 'Emanuel SC Sarinho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UFPE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Emanuel Sávio Cavalcanti Sarinho', 'oldOrganization': 'Universidade Federal de Pernambuco'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-05-31', 'type': 'RELEASE'}, {'date': '2017-10-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jose Angelo Rizzo, MD, PhD, Universidade Federal de Pernambuco'}}}}