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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05395169
Other study ID # P.TREC/012/003692
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date October 1, 2022

Study information

Verified date May 2022
Source Cairo University
Contact Azaa Barmoud, professor
Phone 01008410312
Email drazzakassab@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hypothesis: There will be no effect of the DASH diet and aerobic exercise on premenstrual syndrome. Statement of the problem: Do the DASH diet and aerobic exercise have an effect on premenstrual syndrome?


Description:

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. DASH 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. Diets 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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date October 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 25 Years
Eligibility Inclusion Criteria: - Fifty adolescent females were diagnosed with premenstrual syndrome. - Their age will be ranged from 15-to 25 years (3 years post-puberty). - Their body mass index (BMI) will range from 18-25.9 kg/m2. - All are of regular menstrual cycles. - All of them suffer from moderate and severe PMS. Exclusion Criteria: - Any pathologic findings in the pelvic cavity as a polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases. - Having irregular menstruation. - Any metabolic diseases. - Any history of gynecological intervention.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
dietary supplement ,electronic treadmill ,DASH diet.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue scale (VAS) Visual analogue scale (VAS):
Degrees 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"
assessment will be take 12 weeks
Primary Menstrual Distress Questionnaire (MDQ) Menstrual Distress Questionnaire (MDQ):
The 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.
assessment will be take 12 weeks
See also
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Completed NCT03529721 - Effect of Zumba Dance on Premenstrual Tension N/A
Recruiting NCT02504515 - Effect of Homeopathy, Acupuncture or Anthroposophic Medicine in Women's Quality of Life N/A