Premenstrual TensionNCT05395169
EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
A study testing dietary supplement ,electronic treadmill ,DASH diet. in people with Premenstrual Tension, run by Cairo University.
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? Read more about this study
- Who is it for?
- Ages 15 to 25 years, women only
- Conditions the study is for
- Premenstrual Tension
- What is being tested?
- dietary supplement ,electronic treadmill ,DASH diet.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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?
Read the detailed 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 .
- Conditions
- Premenstrual Tension
- Being tested
- dietary supplement ,electronic treadmill ,DASH diet.
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplement ,electronic treadmill ,DASH diet.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| medical treatment | Experimental | 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. Receives: Other: dietary supplement ,electronic treadmill ,DASH diet. |
| the same medication, in addition to DASH diet and aerobic exercise | Experimental | 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. Receives: Other: dietary supplement ,electronic treadmill ,DASH diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: assessment will be take 12 weeks
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.
Measured: assessment will be take 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual TensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mabrouk El-Said Anwer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395169
- Sponsor's protocol ID
- P.TREC/012/003692
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
- ClinicalTrials.gov ID
- NCT05395169
- Acronym / sponsor ID
- P.TREC/012/003692
- Conditions
- Premenstrual Tension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed 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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medical treatment | Experimental | Other: dietary supplement ,electronic treadmill ,DASH diet.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. |
| the same medication, in addition to DASH diet and aerobic exercise | Experimental | Other: dietary supplement ,electronic treadmill ,DASH diet.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. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | medical treatment, the same medication, in addition to DASH diet and aerobic exercise |
Primary outcome
Visual analogue scale (VAS)
Time frame: assessment will be take 12 weeks
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"
Menstrual Distress Questionnaire (MDQ)
Time frame: assessment will be take 12 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: Yes
Related trials for Premenstrual Tension
RecruitingObservational study
Personalize My Treatment (PMT) Registry
Cancer
RecruitingPhase 1/2
Safety and Efficacy of PMT Therapy of hPAP
Hereditary Pulmonary Alveolar Proteinosis
Active, not recruitingPhase 1
Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma
Glioma, Malignant
Enrolling by invitation
Preservation of Venous Valvular Function After PMT for Acute DVT
Acute Deep Venous Thrombosis of Femoral Vein (Disorder)
Active, not recruiting
PMT-Based Radiation Safety Training for Nurses: Randomized Controlled Trial.
Occupational Radiation Exposure in Operating Room Nurses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplement ,electronic treadmill ,DASH diet. in people with Premenstrual Tension, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azaa Barmoud, professor (01008410312, drazzakassab@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: assessment will be take 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.