Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT01414335
Status:
COMPLETED
Last Update Posted:
2011-08-11
First Post:
2011-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000088562', 'term': 'Persistent Infection'}, {'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-10', 'studyFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'outcome of efficacy', 'timeFrame': '3 month treatment', 'description': 'For each study day,participants recorded in a diary rectal temperature, symptoms of sneezing, blocked nose or streaming eyes, whether they had problems to swollow and whether they had headache or pain in arms or legs.'}], 'secondaryOutcomes': [{'measure': 'outcome of efficacy', 'timeFrame': '3 month treatment', 'description': 'Secondary outcome variables: feel the patient fit and able-bodied.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['amino acids', 'immune system', 'vitamins', 'chronic infection', 'common cold', 'ear', 'nose', 'throat'], 'conditions': ['to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effectiveness of a dietary supplement with high dosage of amino acids and vitamins in the treatment of acute and chronic infection of pharyngeal area known as common cold. T'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nmen and women with at least two episodes of common cold and infection of ear, nose and pharyngeal area.\n\nExclusion Criteria:\n\n* people with severe infection like pneumonia, patients expecting an in-patient treatment during the trial, pregnant or breast feeding and people not able to understand the procedure of the treatment'}, 'identificationModule': {'nctId': 'NCT01414335', 'briefTitle': 'Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyberg Vital GmbH'}, 'officialTitle': 'Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Randomized Completely Masked Trial', 'orgStudyIdInfo': {'id': 'Kyb10/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'amino acid composition', 'interventionNames': ['Dietary Supplement: amino acid composition']}], 'interventions': [{'name': 'amino acid composition', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Brand name: aminoplus immun'], 'description': 'one single pouch (13g) of amino acid mixture and vitamins diluted into 200 ml of still water. This solution was daily oral taken after a meal.', 'armGroupLabels': ['amino acid composition']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['remedy'], 'description': 'placebo contained no amino acids and vitamins and was identical in appearance and solution properties.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82041', 'city': 'Oberhaching', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Kyberg Vital - Doris Meister', 'geoPoint': {'lat': 48.02455, 'lon': 11.59744}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyberg Vital GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sponsor: Kyberg Vital GmbH', 'oldOrganization': 'Sponsor: Kyberg Vital GmbH'}}}}