Primary DysmenorrheaNCT06705413
Effect of Lifestyle Modification on Obese Females With Primary Dysmenorrhea
A study testing Aerobic exercise and Microbiome diet in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
The study will be designed to determine the effect of lifestyle modification on primary dysmenorrhea in obese females. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Aerobic exercise and Microbiome diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Dec 2025
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young females with moderate to severe primary dysmenorrhea (Visual analogue scale > 4).
- Virgin, nonsmokers.
- Young female aged from 18-25 years with BMI more than 30 kg/m².
- They have regular menstrual cycles (a menstrual flow of 38 days, with 21-35 days between menstrual flows)
- They have not practiced sports for at least one year before entering the study.
- They have not engaged in diet for at least one year before entering the study.
Who cannot join
- Any participant having Secondary dysmenorrhea (associated with identifiable pelvic pathology).
- Any participant with a history of pelvic inflammatory disease, myoma and tumors, pelvic infection, ovarian cyst, any gynecological disease.
- Any participant with a history of previous spinal surgeries.
- Any participant with a history of Anemia, diabetes, hypertension, cardiovascular disease, thyroid disease, neurological disorder, rheumatoid arthritis, bariatric surgery, or taking weight loss medication.
Trial locations and contacts
1 site in 1 country.
About this study
The study will be designed to determine the effect of lifestyle modification on primary dysmenorrhea in obese females.
Read the detailed description
Menstruation in women after puberty is often confused with dysmenorrhea. Primary dysmenorrhea, where there is no apparent pelvic pathology, is characterized as painful menstrual cramps. This symptom typically occurs within one to two years of menarche and menstrual cycle stabilisation1. Pain occurs a couple of hours before or after menstruation and lasts for 12 to 72 hours. Dysmenorrhea can also be accompanied by nausea, discomfort, low back pain, or flank pain.
Obesity in women adolescents is one of the factors associated with dysmenorrhea also; Endometrium production of physiological prostaglandin increased in primary dysmenorrhea. Increased prostaglandin directly contributes to uterine contractions that eventually lead to primary dysmenorrhea. Overweight and obesity thought to be correlated with dysmenorrhea by increasing the development of prostaglandin.
The Microbiome Diet is a new, trendy weight loss diet. It created by Dr. Raphael Kellman and based on eating and avoiding certain foods in the hopes of restoring gut health. It's also claimed to offer other benefits, such as a faster metabolism and weight loss. Therefore, this study aims to investigate the effect of lifestyle modification on obese females suffering from primary dysmenorrhea
- Conditions
- Primary Dysmenorrhea
- Being tested
- Aerobic exercise, Microbiome diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
a program consists of 10 minutes warming up, 30 minutes of aerobic exercises in the form of core strengthening exercises and stretching exercises and finally 10 minutes of cooling down. The participant will receive the aerobic program 4 sessions /week for three consecutive menstrual cycles.
Microbiome dietOther
The participants will receive Microbiome diet for three consecutive menstrual cycles. A three-phase diet (21-day phase, 28-day phase and maintenance phase) will be followed by the experimental group which contains some food restrictions and addition for certain food types which may improve gut health.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise group | Active comparator | The participants will receive a program of aerobic exercise for 3 consecutive menstrual cycles. Receives: Other: Aerobic exercise |
| Aerobic exercise and microbiome diet group | Experimental | The participants will receive aerobic exercise in addition to microbiome diet for 3 consecutive menstrual cycles. Receives: Other: Aerobic exercise; Other: Microbiome diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level assessment
The visual analogue scale will be used to measure menstrual pain intensity for both groups before and after treatment.it is a valid and reliable 10 cm line ranging from 0 to 10. 0 indicates no pain,10 indicates worst pain.
Measured: 3 months
Assessment of severity of dysmenorrhea
WaLIDD scale will be used to determine the severity of dysmenorrhea for each female in both groups by combining subjective (intensity/wong-baker, work ability) and objective (days of pain, location) manifestations for both groups. its score ranges between 0 and 3, and the final score ranges from 0 to 12 points. the higher the score, the greater the severity of dysmenorrhea.
Measured: 3 months
Assessment of pain pressure threshold
the pressure algometer will be used to assess pain pressure threshold for all females in both groups before and after treatment on the following points: A-Two measurements 4cm from the umbilicus, bilaterally (points I and II) B-Two other measurements 4cm below the previous ones (points III and IV) C. A single measurement 4cm from the lower margin of the umbilicus (point V). D. Another single measurement into the medial side of the lumbar region below the fifth lumbar vertebra, corresponding to S2-S4 (point VI).
Measured: 3 months
Body mass index
Weight and height measurement will be measured for each participant in both groups before and after the treatment to calculate her BMI according to the following equation:
BMI (kg/m2) = Weight (kg) / Height² (m2).
Measured: 3 months
Waist and hip ratio measurement:
Waist hip circumference were taken for each woman in both groups before and after the treatment course for calculating waist and hip ratio (WHR) by dividing the waist circumference (WC) on hip circumference (HC). By the tape measurement, (WC) was measured at the narrowest circumference between xipho-sternum and the iliac crest at the end of gentle expiration. HC was measured at the maximum circumference at the level of femoral trochanter.
Measured: 3 months
Secondary outcomes (3)
Measurement of lumbar mobility
By using the modified Schober test, the participant will be asked to stand; the therapist will mark both posterior superior iliac spines (PSIS) and then will draw a horizontal line connecting the center of both marks. A second line will be marked 5 cm below the first line and a third line will be marked 10 cm above the first line. The participant will be instructed to flex forward as if attempting to touch her toes, then therapist will re-measure the distance between the top and bottom line. The increased distance along the tap due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal)
Measured: 3 months
Measurement of lumbar lordotic curve
The subjects will be asked to stand with lower back and upper buttocks exposed on the markings done by adhesive tape on the floor with a distance of 15 cm between feet.
The flexible ruler will be placed over the lumbar spinous process and the readings on the flexible ruler that intersected with the markings done on spinous processes will be noted.
The vertical line (L) will be drawn to connect the spinous processes T12 and S2 landmarks and will be labelled as A and B respectively. The deepest point of the curve will be identified by recording the steep of the curve and a perpendicular line (H) from the point to the line L will be drawn. The L and H lengths will be measured in cm The measurements will be recorded after removing the flexible ruler without changing the curve. Then, the outline of the curve will be traced from the readings for T12 to S2 spinous processes using a pencil along the flexible ruler onto the graph sheet its normal value is ranged between 20° and 45°.
Measured: 3 months
Assessment of Health-Related Quality of Life
It will be assessed before and after treatment program using Free online SF-36 score calculator. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). Responses will be scored on a five point scale (from "very poor" to "very good"), where higher scores indicate better enjoyment and satisfaction with life. Scores will be added and presented as a percentage of the total maximum score. A percentage of total score of > 70 represents normal quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jan 2025
- Primary completion15 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies 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
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Taha Abd EL-Hamed, Cairo University
- Investigators
- Doaa Osman, professor, Study director, Cairo UniversityAmel Yousef, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705413
- Sponsor's protocol ID
- P.T.REC/012/005311
- Status last verified
- May 2026
- First submitted
- 22 Nov 2024
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lifestyle Modification on Obese Females With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06705413
- Acronym / sponsor ID
- P.T.REC/012/005311
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 26 Nov 2024 (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.
The study will be designed to determine the effect of lifestyle modification on primary dysmenorrhea in obese females.
Detailed description
Menstruation in women after puberty is often confused with dysmenorrhea. Primary dysmenorrhea, where there is no apparent pelvic pathology, is characterized as painful menstrual cramps. This symptom typically occurs within one to two years of menarche and menstrual cycle stabilisation1. Pain occurs a couple of hours before or after menstruation and lasts for 12 to 72 hours. Dysmenorrhea can also be accompanied by nausea, discomfort, low back pain, or flank pain.
Obesity in women adolescents is one of the factors associated with dysmenorrhea also; Endometrium production of physiological prostaglandin increased in primary dysmenorrhea. Increased prostaglandin directly contributes to uterine contractions that eventually lead to primary dysmenorrhea. Overweight and obesity thought to be correlated with dysmenorrhea by increasing the development of prostaglandin.
The Microbiome Diet is a new, trendy weight loss diet. It created by Dr. Raphael Kellman and based on eating and avoiding certain foods in the hopes of restoring gut health. It's also claimed to offer other benefits, such as a faster metabolism and weight loss. Therefore, this study aims to investigate the effect of lifestyle modification on obese females suffering from primary dysmenorrhea
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise group | Active comparator | Other: Aerobic exerciseThe participants will receive a program of aerobic exercise for 3 consecutive menstrual cycles. |
| Aerobic exercise and microbiome diet group | Experimental | Other: Aerobic exercise, Other: Microbiome dietThe participants will receive aerobic exercise in addition to microbiome diet for 3 consecutive menstrual cycles. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Young females with moderate to severe primary dysmenorrhea (Visual analogue scale > 4).
- Virgin, nonsmokers.
- Young female aged from 18-25 years with BMI more than 30 kg/m².
- They have regular menstrual cycles (a menstrual flow of 38 days, with 21-35 days between menstrual flows)
- They have not practiced sports for at least one year before entering the study.
Key exclusion criteria (4 listed)
- Any participant having Secondary dysmenorrhea (associated with identifiable pelvic pathology).
- Any participant with a history of pelvic inflammatory disease, myoma and tumors, pelvic infection, ovarian cyst, any gynecological disease.
- Any participant with a history of previous spinal surgeries.
- Any participant with a history of Anemia, diabetes, hypertension, cardiovascular disease, thyroid disease, neurological disorder, rheumatoid arthritis, bariatric surgery, or taking weight loss medication.
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 |
|---|---|---|
| Aerobic exercisea program consists of 10 minutes warming up, 30 minutes of aerobic exercises in the form of core strengthening exercises and stretching exercises and finally 10 minutes of cooling down. The participant will receive the aerobic program 4 sessions /week for three consecutive menstrual cycles. | Other | Aerobic exercise and microbiome diet group, Aerobic exercise group |
| Microbiome dietThe participants will receive Microbiome diet for three consecutive menstrual cycles. A three-phase diet (21-day phase, 28-day phase and maintenance phase) will be followed by the experimental group which contains some food restrictions and addition for certain food types which may improve gut health. | Other | Aerobic exercise and microbiome diet group |
Primary outcome
Pain level assessment
Time frame: 3 months
The visual analogue scale will be used to measure menstrual pain intensity for both groups before and after treatment.it is a valid and reliable 10 cm line ranging from 0 to 10. 0 indicates no pain,10 indicates worst pain.
Assessment of severity of dysmenorrhea
Time frame: 3 months
WaLIDD scale will be used to determine the severity of dysmenorrhea for each female in both groups by combining subjective (intensity/wong-baker, work ability) and objective (days of pain, location) manifestations for both groups. its score ranges between 0 and 3, and the final score ranges from 0 to 12 points. the higher the score, the greater the severity of dysmenorrhea.
Assessment of pain pressure threshold
Time frame: 3 months
the pressure algometer will be used to assess pain pressure threshold for all females in both groups before and after treatment on the following points: A-Two measurements 4cm from the umbilicus, bilaterally (points I and II) B-Two other measurements 4cm below the previous ones (points III and IV) C. A single measurement 4cm from the lower margin of the umbilicus (point V). D. Another single measurement into the medial side of the lumbar region below the fifth lumbar vertebra, corresponding to S2-S4 (point VI).
Body mass index
Time frame: 3 months
Weight and height measurement will be measured for each participant in both groups before and after the treatment to calculate her BMI according to the following equation: BMI (kg/m2) = Weight (kg) / Height² (m2).
Waist and hip ratio measurement:
Time frame: 3 months
Waist hip circumference were taken for each woman in both groups before and after the treatment course for calculating waist and hip ratio (WHR) by dividing the waist circumference (WC) on hip circumference (HC). By the tape measurement, (WC) was measured at the narrowest circumference between xipho-sternum and the iliac crest at the end of gentle expiration. HC was measured at the maximum circumference at the level of femoral trochanter.
3 secondary outcomes
Measurement of lumbar mobility
Time frame: 3 months
Measurement of lumbar lordotic curve
Time frame: 3 months
Assessment of Health-Related Quality of Life
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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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.
Doaa Osman, professor study director
Cairo University
Amel Yousef, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Microbiome diet in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level assessment (time frame: 3 months). The study lists 5 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 6 May 2026.