Premenstrual SyndromeNCT07737210
Effect of Electroacupuncture on Premenstrual Syndrome in Young Women
A study testing Nutritional Supplement and electroacupuncture in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study was to determine the effect of electroacupuncture on premenstrual syndrome in young women. Read more about this study
- Who is it for?
- Ages 20 to 29 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Nutritional Supplement and electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Aug 2025to 30 Jan 2026
- 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 20 to 29 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with or suffering from premenstrual syndrome.
- Regular menstrual cycles.
- Age from 20 to 29 years.
- Body mass index (BMI) from 25 to 29.9 kg/m².
- Single, virginal, and non-smoking participants.
Who cannot join
- Cardiorespiratory, renal, neurological, pelvic inflammatory, thyroid, or mental disorders.
- Anemia, diabetes mellitus, hypertension, asthma, rheumatoid arthritis, headache, or migraine.
- Acupuncture treatment during the preceding six months.
- Pregnancy or intention to become pregnant.
- Participation in another exercise or training program during the study.
- Use of medications or hormonal treatment that could influence the study outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to determine the effect of electroacupuncture on premenstrual syndrome in young women.
Read the detailed description
Premenstrual syndrome (PMS) begins during fertility years and ceases at menopausal period. This syndrome manifests itself during every monthly luteal stage in the form of a complex of somatic, psychological and behavioral disorders. It usually starts 6 to 12 days before menstruation and it lasts 2 to 4 days after menstrual bleeding.
Surgical treatment, drug treatment (such as hormonal use, antidepressant and analgesic drugs) and non-drug therapies (such as lifestyle changes and exercise). Considering the side effects of drug and surgical treatments, non-drug therapies, especially physical activity, have attracted the attention of specialists and women with the disease.
Previous studies reported that a combination of Mg and vitamin B6 induced a reduction of mild premenstrual anxiety-related symptoms and the mean score of (PMS).
So, This study provided evidences of the effect of electroacupuncture on premenstrual syndrome in young women for all health care providers who are interested in the field of women's health.
- Conditions
- Premenstrual Syndrome
- Being tested
- Nutritional Supplement, electroacupuncture
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementDietary supplement
The participants received daily nutritional supplementation for three consecutive menstrual cycles, consisting of calcium 800-1000 mg/day, magnesium 250 mg/day, vitamin B6, and zinc 10 mg/day.
electroacupunctureDevice
- Total number of electroacupuncture sessions: 21 sessions.
- Schedule: 7 consecutive daily sessions during each menstrual cycle for 3 consecutive cycles.
- Timing in each cycle: treatment started 3 days before the expected onset of menstruation and continued through the fourth day of menstruation.
- Session duration: approximately 20-30 minutes.
- Needle specification used in the actual procedure: sterile filiform needles, 0.30 mm × 40 mm.
- Needle sensation: insertion was performed to elicit Deqi.
- Electrical stimulation device: TensCare; dense-wave mode.
- Acupuncture points: LI4 (Hegu), LI11 (Quchi), P6 (Neiguan), LIV3/LR3 (Taichong), SP6 (Sanyinjiao), ST36 (Zusanli), DU20 (Baihui), REN2 (Qugu), REN6 (Qihai), and REN12 (Zhongwan).
| Study group | Role | What they receive |
|---|---|---|
| nutritional supplement group | Active comparator | The participants received daily nutritional supplementation for three consecutive menstrual cycles Receives: Dietary Supplement: Nutritional Supplement |
| nutritional supplements and electroacupuncture group | Experimental | The participants received daily nutritional supplement in addition to electroacupuncture for three consecutive menstrual cycles. Receives: Dietary Supplement: Nutritional Supplement; Device: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual syndrome severity
Premenstrual syndrome severity was measured using the Premenstrual Syndrome Questionnaire (PMSQ). It was assessed during the late luteal phase at baseline before the first treatment session and again during the late luteal phase after completion of the three-cycle intervention period. Premenstrual Syndrome Questionnaire (PMSQ) scoring evaluates symptom severity on a 3-point scale (1 = mild, 2 = moderate, 3 = severe) across categories like anxiety, fluid retention, and mood changes to determine the impact of premenstrual changes. Lower scores indicate improvement in premenstrual syndrome symptoms.
Measured: 3 months
Secondary outcomes (2)
Serum progesterone concentration (ng/mL).
A 5-mL venous blood sample was collected from each participant in both groups before treatment and again after completion of three consecutive menstrual cycles during the individualized mid-luteal phase, approximately 6-8 days before the expected onset of menstruation according to each participant's usual cycle length. Normal value of progesterone in luteal phase:0.95-21 ng/ml.
Measured: 3 months
Serum estradiol (E2)
A 5-mL venous blood sample was collected from each participant in both groups before treatment and again after completion of three consecutive menstrual cycles during the individualized mid-luteal phase, approximately 6-8 days before the expected onset of menstruation according to each participant's usual cycle length. Normal value of estrogen E2 in luteal phase:27-246 pg/ml.
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 posted30 Jul 2026
- Study start31 Aug 2025
- Primary completion26 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholud Khaled Sayed, Cairo University
- Investigators
- Hossam Kamel, professor, Study director, Al-Azhar UniversityAbeer El-Deeb, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737210
- Sponsor's protocol ID
- P.T.REC/012/004350
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture on Premenstrual Syndrome in Young Women
- ClinicalTrials.gov ID
- NCT07737210
- Acronym / sponsor ID
- P.T.REC/012/004350
- Conditions
- Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 30 Jul 2026 (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 aim of this study was to determine the effect of electroacupuncture on premenstrual syndrome in young women.
Detailed description
Premenstrual syndrome (PMS) begins during fertility years and ceases at menopausal period. This syndrome manifests itself during every monthly luteal stage in the form of a complex of somatic, psychological and behavioral disorders. It usually starts 6 to 12 days before menstruation and it lasts 2 to 4 days after menstrual bleeding.
Surgical treatment, drug treatment (such as hormonal use, antidepressant and analgesic drugs) and non-drug therapies (such as lifestyle changes and exercise). Considering the side effects of drug and surgical treatments, non-drug therapies, especially physical activity, have attracted the attention of specialists and women with the disease.
Previous studies reported that a combination of Mg and vitamin B6 induced a reduction of mild premenstrual anxiety-related symptoms and the mean score of (PMS).
So, This study provided evidences of the effect of electroacupuncture on premenstrual syndrome in young women for all health care providers who are interested in the field of women's health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutritional supplement group | Active comparator | Dietary Supplement: Nutritional SupplementThe participants received daily nutritional supplementation for three consecutive menstrual cycles |
| nutritional supplements and electroacupuncture group | Experimental | Dietary Supplement: Nutritional Supplement, Device: electroacupunctureThe participants received daily nutritional supplement in addition to electroacupuncture for three consecutive menstrual cycles. |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women diagnosed with or suffering from premenstrual syndrome.
- Regular menstrual cycles.
- Age from 20 to 29 years.
- Body mass index (BMI) from 25 to 29.9 kg/m².
- Single, virginal, and non-smoking participants.
Key exclusion criteria (6 listed)
- Cardiorespiratory, renal, neurological, pelvic inflammatory, thyroid, or mental disorders.
- Anemia, diabetes mellitus, hypertension, asthma, rheumatoid arthritis, headache, or migraine.
- Acupuncture treatment during the preceding six months.
- Pregnancy or intention to become pregnant.
- Participation in another exercise or training program during the study.
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 |
|---|---|---|
| Nutritional SupplementThe participants received daily nutritional supplementation for three consecutive menstrual cycles, consisting of calcium 800-1000 mg/day, magnesium 250 mg/day, vitamin B6, and zinc 10 mg/day. | Dietary supplement | nutritional supplement group, nutritional supplements and electroacupuncture group |
| electroacupuncture* Total number of electroacupuncture sessions: 21 sessions. * Schedule: 7 consecutive daily sessions during each menstrual cycle for 3 consecutive cycles. * Timing in each cycle: treatment started 3 days before the expected onset of menstruation and continued through the fourth day of menstruation. * Session duration: approximately 20-30 minutes. * Needle specification used in the actual procedure: sterile filiform needles, 0.30 mm × 40 mm. * Needle sensation: insertion was performed to elicit Deqi. * Electrical stimulation device: TensCare; dense-wave mode. * Acupuncture points: LI4 (Hegu), LI11 (Quchi), P6 (Neiguan), LIV3/LR3 (Taichong), SP6 (Sanyinjiao), ST36 (Zusanli), DU20 (Baihui), REN2 (Qugu), REN6 (Qihai), and REN12 (Zhongwan). | Device | nutritional supplements and electroacupuncture group |
Primary outcome
Premenstrual syndrome severity
Time frame: 3 months
Premenstrual syndrome severity was measured using the Premenstrual Syndrome Questionnaire (PMSQ). It was assessed during the late luteal phase at baseline before the first treatment session and again during the late luteal phase after completion of the three-cycle intervention period. Premenstrual Syndrome Questionnaire (PMSQ) scoring evaluates symptom severity on a 3-point scale (1 = mild, 2 = moderate, 3 = severe) across categories like anxiety, fluid retention, and mood changes to determine the impact of premenstrual changes. Lower scores indicate improvement in premenstrual syndrome symptoms.
2 secondary outcomes
Serum progesterone concentration (ng/mL).
Time frame: 3 months
Serum estradiol (E2)
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 30 Jul 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.
Hossam Kamel, professor study director
Al-Azhar University
Abeer El-Deeb, 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 Nutritional Supplement and electroacupuncture in people with Premenstrual Syndrome, 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 5 inclusion and 6 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 30 Jul 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?
Premenstrual syndrome severity (time frame: 3 months). 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 30 Jul 2026.