Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-04-02 @ 8:05 AM
Study NCT ID:
NCT02032251
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Sperm DNA Fragmentation by Oral Ginger
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-08', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sperm DNA fragmentation', 'timeFrame': '3 months', 'description': 'Evaluation the percent of the reduction of sperm DNA fragmentation 3 months after ginger administration.'}], 'secondaryOutcomes': [{'measure': 'male hormones', 'timeFrame': '3months', 'description': 'Evaluation the effect of ginger on male hormones 3 months after oral administration.'}, {'measure': 'sperm count', 'timeFrame': '3 months', 'description': 'Evaluation the ginger on sperm count 3 months after oral administration.'}, {'measure': 'sperm motility', 'timeFrame': '3 months', 'description': 'Evaluation the effect of ginger on sperm motility 3 months after oral administration.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sperm DNA damage ejaculated spermatozoa Ginger Herbal Drug Herbal medicine'], 'conditions': ['Infertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://Royaninstitute.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double blind, controlled clinical trials assess the efficacy of the ginger oral treatment on sperm DNA fragmentation, sperm parameters and male hormones.', 'detailedDescription': 'Sperm DNA fragmentation is known to affect male fertility. Previous findings have suggested the implication of oxidative stress in the etiology of this pathological condition. The present study was designed to find out DNA fragmentation in ejaculated spermatozoa can be reduced by oral treatment with Ginger extract. 71 men with unexplained or Idiopathic infertility were randomized between a Ginger treatment (500 milligram daily for 3months) group and a placebo group.\n\nSperm DNA fragmentation was evaluated by Terminal deoxyribonucleotidyltransferase-mediated dUTP nick-end labeling assay (TUNEL) before and after treatment. No differences in basic sperm parameters were found between the Ginger treatment and the placebo group before or after treatment. However, the percentage of DNA-fragmented spermatozoa was markedly reduced (P\\< .005) in the Ginger treatment group after the treatment as compared with the pretreatment values). No difference in the pretreatment and post treatment incidence of sperm DNA fragmentation was observed in the placebo group. These data show that sperm DNA damage can be efficiently treated with oral Ginger extract administered during a relatively short time period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men with idiopathic infertility or unexplained\n\nExclusion Criteria:\n\n* history of varicocele, genitourinary inflammation or infection\n* history of cigarette smoking.'}, 'identificationModule': {'nctId': 'NCT02032251', 'briefTitle': 'Reduction of Sperm DNA Fragmentation by Oral Ginger', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Reduction of Sperm DNA Fragmentation by Oral Ginger (Zingiberofficinale) Extract Treatment', 'orgStudyIdInfo': {'id': 'royan-Emb-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ginger', 'description': 'The patients with infertility that underwent oral administration of ginger.', 'interventionNames': ['Drug: oral administration of ginger']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The patients with infertility that receive placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'oral administration of ginger', 'type': 'DRUG', 'otherNames': ['Administration of herbal drug'], 'description': 'Oral administration of ginger in patients with infertility.', 'armGroupLabels': ['ginger']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Hamid Gourabi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Royan Institute'}, {'name': 'Ali DaliriHampa, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine'}, {'name': 'Eyed Jalil Hosseini, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine'}, {'name': 'Hani Department of Andrology, Reproductive Biomedicine Center, Roya, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Andrology, Reproductive Biomedicine Center, Royan Institute for Reproductive Biomedicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}