Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-27 @ 12:51 PM
Study NCT ID:
NCT05029492
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2021-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Visceral Manipulation on PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D031204', 'term': 'Caloric Restriction'}, {'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D044382', 'term': 'Population Groups'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "an independent researcher assigned the participants to one of the two study groups, by opening sealed envelopes containing serially ordered numbers. An independent assessor analyzed the patients' blood samples for hormonal profile and another assessor blinded to patients' allocation interviewed the patients for the questionnaire and assessed the weight."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Polycystic ovarian women were assigned to either group (A), receiving a low-calorie diet for three months, or group (B), receiving the same diet as group (A) together with visceral manipulation of the pelvic organs and their related structures for the same study period (three months).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2021-08-15', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change of menstrual complaints' severity", 'timeFrame': 'At baseline and after three months of the intervention.', 'description': 'The total score of menstruation- specific domain of polycystic ovarian syndrome questionnaire (PCOSQ) questions, calculated using the following equation: Number of patient/ group x number of questions/ domain. That total score was then used to determine the percentage of change from severity towards the optimal function.'}], 'secondaryOutcomes': [{'measure': 'Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio)', 'timeFrame': 'At baseline in the second day of menstruation and after three months of the intervention.', 'description': 'Human LH and FSH enzyme linked immunosorbent assay (ELISA) kits were used to assess the level of LH and FSH in the blood sample taken from each patient.'}, {'measure': 'Change in weight', 'timeFrame': 'At baseline and after three months of the intervention.', 'description': 'A weight- height scale is used to assess body weight in kilograms.'}, {'measure': 'Change in Body mass index (BMI)', 'timeFrame': 'At baseline and after three months of the intervention.', 'description': 'BMI is measured by the equation weight (Kg)/ height (m\\^2)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Polycystic Ovary Syndrome', 'Menstruation Disturbances', 'Caloric Restriction', 'Manipulation Therapy'], 'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'The study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome. Thirty women were randomly and equally assigned into the group (A) (Control group), who received a low caloric diet (1200 Kcal/day) only for 3 months, and the group (B) (Study group), who received visceral manipulation to the pelvic organs and the related structures in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study were done for body weight, BMI, female reproductive hormones, and menstruation-related problems.', 'detailedDescription': 'The current study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome (PCOS). Thirty women having PCOS were chosen from the outpatient clinic of the faculty of physical therapy, Cairo University. Patients were randomly assigned into two groups equal in number. Group (A) (Control group), 15 PCOS women received a low caloric diet (1200 Kcal/day) for 3 months, while group (B) (Study group), 15 PCOS women received visceral manipulation to the pelvic organs and the related structures (8 sessions, once per week in the first month then once every other week for two months) in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study for body weight, body mass index, female reproductive hormones \\[luteinizinghormone (LH), follicle-stimulating hormone (FSH) and LH/FSH ratio\\] and menstruation-related problems were done by weight- height scale, blood analysis, and menstruation-specific domain of polycystic ovary syndrome health-related quality of life questionnaire (PCOSQ), respectively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women having PCOS.\n* 25 ≤ BMI ≤ 30 Kg/m2.\n* Waist/hip ratio ≤ 0.80.\n* Women experiencing irregular menstrual cycles.\n\nExclusion Criteria:\n\n* Having cardiovascular diseases, diabetes mellitus, and/ or hypertension\n* Having malignancy.\n* Presence of reproductive disorders unrelated to PCOS.\n* Presence of adrenal gland abnormalities.'}, 'identificationModule': {'nctId': 'NCT05029492', 'briefTitle': 'Effect of Visceral Manipulation on PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Visceral Manipulation on Polycystic Ovarian Syndrome', 'orgStudyIdInfo': {'id': 'P.T.REC/012/001044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diet group', 'description': 'Giving a low caloric diet', 'interventionNames': ['Other: Low-calorie diet']}, {'type': 'EXPERIMENTAL', 'label': 'Visceral manipulation with diet group', 'description': 'Giving visceral manipulation added to a low-calorie diet', 'interventionNames': ['Other: Visceral manipulation with diet']}], 'interventions': [{'name': 'Low-calorie diet', 'type': 'OTHER', 'otherNames': ['Control group', 'Group (A)'], 'description': 'Low-calorie diet of 1200 kcal for 3 months, modified every two weeks.', 'armGroupLabels': ['Diet group']}, {'name': 'Visceral manipulation with diet', 'type': 'OTHER', 'otherNames': ['Study group', 'Group (B)'], 'description': 'Visceral manipulation to the pelvic organs and their related structures (8 sessions, once per week in the first month then once every other week for two months) added to the same low-calorie diet as the group (A).', 'armGroupLabels': ['Visceral manipulation with diet group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': "Mahitab Yosri, Lecturer of women's health", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahitab Mohammed Yosri Ibrahim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Lecturer of physical therapy for women's health", 'investigatorFullName': 'Mahitab Mohammed Yosri Ibrahim', 'investigatorAffiliation': 'Cairo University'}}}}