An interventional study of Medical treatment. and weight reduction in Premenstrual Syndrome, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
The purpose of this study will be investigation of the effect of weight reduction and aerobic exercises on premenstrual syndrome symptoms in obese females.
both groups (A\&B) will take their medical treatment in the form of (NSAIDs) and the study group B will under go a siet plan which will fits the participants. Diet plan extends for 12 weeks in the form of caloric restriction program and each woman in group B will perform aerobic exercise program, in the form of treadmill 3 times/week for 8 weeks for 12 weeks. Each session will take about 30 minutes as the following: 5 minutes warming up exercises by walking on the treadmill by low speed, 20 minutes walking at moderate intensity (70% of the maximal heart rate) and 5 minutes are cooling down by walking on the treadmill by low speed as in warming up.
182 studies on the registry are indexed under Premenstrual Syndrome; 30 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 157 interventional studies indexed under Premenstrual Syndrome.
Browse Premenstrual Syndrome studies →Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Group A: (control group): 20 participants Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs)
Drug: Medical treatment.
Group B: (Study group): 20 participants * Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs). * Physical therapy program weight reduction by diet program in the form of caloric restriction, in combination to aerobic exercise in the form of using treadmill 30 minutes /3 times a week for 12 weeks.
Drug: Medical treatment. · Behavioral: weight reduction · Other: exercise
Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).
Also known as: NSAID
weight reduction in the form low caloric diet program for 12 weeks.
Also known as: diet program
aerobic exercise in the form of walking on treadmill for 30 minutes 3 times a week for 12 weeks.
Also known as: aerobic exercise
Progesterone levels in blood
progesterone level will be checked six to eight days after ovulation start (about day 21st of a 28-day cycle)
Time frame: 12 weeks
body weight
Weight and height measurement will be measured while the woman is wearing a thin layer of clothes to calculate the BMI according to the following equation for both groups (A\&B): BMI = weight/height2 (kg/m2).
Time frame: 12 weeks
cortisol levels in blood
All women in both groups (A\&B) will be evaluated before and after the treatment (12 weeks) to show serum cortisol level. A blood sample was taken from each female in both groups (A \& B) before and after the treatment to measure the serum cortisol levels, which could reflect anxiety and pain intensity with decreased cortisol levels indicating decreased pain intensity. The cortisol level was assessed 5 days before the first day of the menstrual cycle preceding the treatment program and 5 days before the first day of the menstrual cycle at the end of treatment program,Blood sample of about 5 cm was drawn from the anticubital vein from all participants by disposable sterile syringe by vein puncture to determine plasma cortisol level. All blood samples were taken at 8-9 am and the norm cortisol level at 9 A.M ranges from 4.3-22.4 ug/dl.
Time frame: 12 weeks
Premenstrual syndrome score
The premenstrual syndrome scale comprised 40 questions with three sub-scales (Physiological, Psychological and Behavioural symptoms). This 5-point Likert- type scale consisting of 40 items. The measurements on the scale are set according to the following scoring system: the response Never was scored as "1", rarely as "2", sometimes as "3", very often as "4" and always as "5" points, the total score obtained from the sub-scales established the "PMSS total score." The scale's lowest score is 40 and highest score is 200. If the scale's total score reached 80 points or above, this indicates the occurrence of PMS. Increases in the scores indicate an increase in PMS severity.
Time frame: 12 weeks
Waist and hip circumference measurements
Waist circumference was measured at the narrowest point between xipho-sternum and the iliac crest at the end of a gentle expiration; hip circumference was measured at the maximum circumference at the level of femoral trochanter. Then, waist/hip ratio was calculated by dividing waist circumference on hip circumference. All measurements were taken for all patients in both groups (A\&B), while the patient was in the standing position, before starting and after the end of the treatment course.
Time frame: 12 weeks
Ran from May 2023 to primary completion in Aug 2023, 3 months.
Of 77 non-industry interventional studies with no phase under Premenstrual Syndrome, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's 3 months is below that.
Counting every sponsor, half of 90 studies reached it within 5 months; a quarter within 3 and three quarters within 10.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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