Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-22 @ 1:29 AM
Study NCT ID:
NCT02998593
Status:
UNKNOWN
Last Update Posted:
2017-04-28
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Combination of Red and White Bahman Retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semen analysis', 'timeFrame': '3 months', 'description': 'Performing the semen analysis to evaluate the sperm count ,sperm motility and sperm morphology.'}], 'secondaryOutcomes': [{'measure': 'Testosterone', 'timeFrame': '3 months', 'description': 'Evaluation the testosterone by ELISA level 3 months after intervention.'}, {'measure': 'FSH', 'timeFrame': '3 months', 'description': 'Evaluation the FSH level by ELISA 3 months after intervention.'}, {'measure': 'LH', 'timeFrame': '3 months', 'description': 'Evaluation the LH level by ELISA 3 months after intervention.'}, {'measure': 'DNA defragmentation', 'timeFrame': '3 months', 'description': 'Evaluation the DNA defragmentation by SCSA Method 3 months after intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Semen parameters Male infertility oligospermia Traditional Medicine'], 'conditions': ['Infertility, Male']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://royaninstitute.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective double blind randomized controlled trial to investigate the effect of red and white bahman on semen parameters, sexual hormones and DNA defragmentation in idiopathic oligospermic men .Include patients will take the medicine and placebo in different two case and control groups for 3 month and semen parameters and other variants at the start and end of study.', 'detailedDescription': 'This is a randomized, double blind; placebo-controlled clinical trial has been started from july 2016 and will continue to july 2016 in Royan institute. The eligible patients who fulfilled the study criteria will be included in the trial.\n\nStudy protocol and assays All the patients will have a complete history evaluation and physical examination by the attending urologist who is blinded to the study and enter the study according to inclusion criteria.. semen analysis and hormonal laboratory tests \\[Testosterone, Luteinizing hormone (LH) Follicle stimulating hormone(FSH)\\] will done in same lab at start of study and 3 month after. Intervention time is 3 month for each patient. semen analysis wil be done according to who laboratory manual for the examination and processing of human semen 5th edition and hormonal tests (LH,FSH,Testosterone) with Elisa method (with score of International Unit). DNA Defragmentation will evaluate with Sperm Chromatin Structure Assay(SCSA) method. semen parameters which will evaluate is the number of normal and abnormal shape sperms, velocity of sperms, volume and viscosity of semen at start and end of the study. medicine and placebo prescribe in 500mg capsules for 3month. red and white Bahman is an effective medicine in male infertility treatment In Iranian Traditional Medicine. at the end of study main aim of the study is evaluation effect of combination of Red and White Bahman retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic . Red Bahman and White bahman ,nutrition ,placebo, smoking and Testosterone,LH,FSH,Concentration,number,sha-pe,of sperm before and after the study is variables of study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. all idiopathic oligospermic patient in range of 20 to 45 years old\n2. sperm count under 15 million /ml 3;No history of taking chemical or herbal medicine effective on sperm genesis in last 3 month( like Hormonal drug ,antidepressant ,anti hypertension,cimetidine, cyproteron, sulphasalazine, flutamide, spironolactone, estrogen,opium 4:No history of Varicocele and Obstructive disease 5:;No leukocytospermia\n\nExclusion Criteria:\n\nTaking chemical or herbal medicine effective on spermatogenesis (hormonal and sperm reducing and increasing agent); 2. ; Increasing BMI \\> 30 3. Leukocytospermia 4. varicocele'}, 'identificationModule': {'nctId': 'NCT02998593', 'briefTitle': 'The Effect of Combination of Red and White Bahman Retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic Men', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Effect of Red and White Bahman on Semen Parameters,Testosteron ,LH, FSH and Defragmentation of DNA . A Double Blind Randomised Clinical Trial (Phase 3)', 'orgStudyIdInfo': {'id': 'Royan-Emb-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'extracted red Bahman and white bahman', 'description': '500 mg of extracted red Bahman and white bahman that is used once a day.', 'interventionNames': ['Drug: Bahman capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '500 mg of placebo once time a day', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bahman capsules', 'type': 'DRUG', 'description': 'Oral Use of Bahman capsules for 3 months by patients.', 'armGroupLabels': ['extracted red Bahman and white bahman']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral use of placebo capsules by patients for 3 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Nasser Aghdami, MD,PhD', 'role': 'CONTACT', 'email': 'nasser.aghdami@royaninstitute.org', 'phone': '(+98)2123562000', 'phoneExt': '516'}, {'name': 'Leila Arab, MD', 'role': 'CONTACT', 'email': 'Leara91@gmail.com', 'phone': '(+98)2123562000', 'phoneExt': '414'}], 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Nasser Aghdami, MD,PhD', 'role': 'CONTACT', 'email': 'nasser.aghdami@royaninstitute.org', 'phone': '(+98)23562000', 'phoneExt': '516'}, {'name': 'Leila Arab, MD', 'role': 'CONTACT', 'email': 'leara91@gmail.com', 'phone': '(+98)23562000', 'phoneExt': '414'}], 'overallOfficials': [{'name': 'Hamid Gourabi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Royan Institute'}, {'name': 'Seyed Jalil Hosseini, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Andrology, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'name': 'Mahmoudreza Faghihi, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran'}, {'name': 'Mina Movahed, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahid Beheshti University of Medical Science _School of Traditional Medicine,Tehran ,Iran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}