Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-03-02 @ 2:05 AM
Study NCT ID:
NCT06702358
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2024-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potential Therapeutic Implications of Laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Laser pointer instruments Product Details Infrared laser diode made in Italy, it must be perpendicular with direct contact to each point.\n\nEach point will stimulate bilaterally by a laser beam of the following parameters wave length 904 nm; strength, 24 mW; energy, 0.1 J; stimulation time, 30 s/point; and two sessions per week for 8 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women', 'timeFrame': 'for 8 weeks', 'description': 'measured in both group before and after treatment. To get in touch with the hunger and satiety cues,BMI ,WHR and serum insulin level.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'for 8 weeks', 'description': 'The weight in kg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-menopausal Women', 'Visceral Fat']}, 'descriptionModule': {'briefSummary': 'Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women', 'detailedDescription': 'All the patients fitted the inclusion criteria, will be given explanation of the treatment protocol in their understandable language.\n\nTreatment procedures. Group (A): will receive laser acupuncture in addition to traditional treatment (low calorie-diet and physical activity) Group (B): will receive traditional treatment only\n\nLaser acupuncture technique:\n\nApplication of laser acupuncture on 10 acupuncture procedure for each woman which will be detected by therapist according to Acupuncture points Will stimulate St 25 (Tianshu), St 36 (Zusanli), Liv 3 (Taichong); P 6 (Neiguan), H 7 (Shenmen) for the psychical aspect of the therapy and Auriculothera- py: 55 (Shenmen) and 87 (Stomach) Each point stimulating will be Stimulation time, 30 s/point two sessions per week for 8 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Post-menopausal Women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menopausal women\n* Woman with visceral obesity\n* with age ranges from 50-65years\n* Body mass index (BMI) more than 30 kg/m2\n* WHR more than 0.8\n\nExclusion Criteria:\n\n* Endometrial cancer\n\n * Insulin resistance\n * Or metabolic disorders\n* Diabetes\n* Hypertensive •NOT receiving any medication of obesity'}, 'identificationModule': {'nctId': 'NCT06702358', 'briefTitle': 'Potential Therapeutic Implications of Laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Potential Therapeutic Implications of Laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women', 'orgStudyIdInfo': {'id': 'KFSIRB200-92'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Infrared laser diode', 'description': 'Laser pointer instruments Product Details Infrared laser diode made in Italy, it must be perpendicular with direct contact to each point.\n\nEach point will stimulate bilaterally by a laser beam of the following parameters wave length 904 nm; strength, 24 mW; energy, 0.1 J; stimulation time, 30 s/point', 'interventionNames': ['Other: Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women']}], 'interventions': [{'name': 'Potential Therapeutic Implications of laser Acupoints on Visceral Fat and Hormonal Changes in Post-menopausal Women', 'type': 'OTHER', 'description': 'Application of laser acupuncture ( E M E ) on 10 acupuncture procedure for each woman which will be detected by therapist according to Acupuncture points Will stimulate St 25 (Tianshu), St 36 (Zusanli), Liv 3 (Taichong); P 6 (Neiguan), H 7 (Shenmen) for the psychical aspect of the therapy and Auriculothera- py: 55 (Shenmen) and 87 (Stomach) Each point stimulating will be Stimulation time, 30 s/point', 'armGroupLabels': ['Infrared laser diode']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'US', 'country': 'Egypt', 'facility': 'Nawal Reda Rashad Mohamed', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "DEPARTEMENT OF PHYSICAL THYRAPY FOR WOMAN'S HEALTH", 'investigatorFullName': 'Nawal Reda Rashad Mohamed', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}