Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT05395169
Status:
UNKNOWN
Last Update Posted:
2022-05-27
First Post:
2022-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011293', 'term': 'Premenstrual Syndrome'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale (VAS)', 'timeFrame': 'assessment will be take 12 weeks', 'description': 'Visual analogue scale (VAS):\n\nDegrees of menstrual pain will be assessed using a VAS for all participants in both groups (A\\&B) before and after treatment, which is a method of representing .participants pain on a 10 cm linear scale. A score of zero mean "a very low degree of pain" and 10 mean "a very high degree of pain"'}, {'measure': 'Menstrual Distress Questionnaire (MDQ)', 'timeFrame': 'assessment will be take 12 weeks', 'description': 'Menstrual Distress Questionnaire (MDQ):\n\nThe subjects decreased activity, lower back pain, tension or anxiety, breast tenderness, and headaches will assess for all participants in both group before and after treatment using Menstrual Distress Questionnaire (MDQ) .Each item will be score on a 5-point likert scale ,with 1 being "no pain at all" follow by "mild pain", "moderate pain", "slightly sever pain" ,and "extremely severe pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premenstrual Tension']}, 'descriptionModule': {'briefSummary': 'Hypothesis:\n\nThere will be no effect of the DASH diet and aerobic exercise on premenstrual syndrome.\n\nStatement of the problem:\n\nDo the DASH diet and aerobic exercise have an effect on premenstrual syndrome?', 'detailedDescription': 'For some women, symptoms of PMS may be so severe that they miss work or school. Physical activity is a suitable method for the treatment of PMS and is the best method for all women to reduce pressure and balance the brain\'s chemical secretion. It seems that physical activity by increasing endorphins and reducing adrenal cortisol leads to the improvement of symptoms of PMS.\n\nDASH diet has been suggested to play an important role in the development, and treatment of some psychological disorders. For instance, it has been reported that a diet rich in fish, folate, and B-vitamins can alleviate the manifestations of depression. An established association was also shown between the dietary glycemic index (GI) and psychological diseases, depressive disorder, and mental functioning.\n\nDiets containing of "junk foods" (high energy and low nutritional) have been shown to increase the risk of mental illness, but a healthy diet is associated with less depressive symptoms and can improve mood .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fifty adolescent females were diagnosed with premenstrual syndrome.\n* Their age will be ranged from 15-to 25 years (3 years post-puberty).\n* Their body mass index (BMI) will range from 18-25.9 kg/m2.\n* All are of regular menstrual cycles.\n* All of them suffer from moderate and severe PMS.\n\nExclusion Criteria:\n\n* Any pathologic findings in the pelvic cavity as a polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.\n* Having irregular menstruation.\n* Any metabolic diseases.\n* Any history of gynecological intervention.'}, 'identificationModule': {'nctId': 'NCT05395169', 'briefTitle': 'EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME', 'orgStudyIdInfo': {'id': 'P.TREC/012/003692'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'medical treatment', 'description': 'Control group:Will be consisted of 25 females suffering from PMS will receive medical treatment in form of vit, B6, ca supplements and minerals (vitatron), once daily(1capsule), for 12 weeks.', 'interventionNames': ['Other: dietary supplement ,electronic treadmill ,DASH diet.']}, {'type': 'EXPERIMENTAL', 'label': 'the same medication, in addition to DASH diet and aerobic exercise', 'description': 'Study group: Will be consisted of 25 females suffering from PMS will Receive the same medication as in group (A) in addition to the DASH diet and aerobic exercise for 30 minutes,3 times/week,for 12 weeks.', 'interventionNames': ['Other: dietary supplement ,electronic treadmill ,DASH diet.']}], 'interventions': [{'name': 'dietary supplement ,electronic treadmill ,DASH diet.', 'type': 'OTHER', 'description': 'Control group Will be receive medical treatment for 12 weeks. Study group Will be receive the same medication as in control group in addition to DASH diet and aerobic exercise for 12 weeks.', 'armGroupLabels': ['medical treatment', 'the same medication, in addition to DASH diet and aerobic exercise']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Azaa Barmoud, professor', 'role': 'CONTACT', 'email': 'drazzakassab@yahoo.com', 'phone': '01008410312'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist physical therapist at Al Delangat Hospital', 'investigatorFullName': 'Eman Mabrouk El-Said Anwer', 'investigatorAffiliation': 'Cairo University'}}}}