NCT07737210

Brief Summary

The aim of this study was to determine the effect of electroacupuncture on premenstrual syndrome in young women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 27, 2026

Last Update Submit

July 27, 2026

Conditions

Premenstrual Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (2)

  • Serum progesterone concentration (ng/mL).

    3 months

  • Serum estradiol (E2)

    3 months

Study Arms (2)

nutritional supplement group

ACTIVE COMPARATOR

The participants received daily nutritional supplementation for three consecutive menstrual cycles

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.

Dietary Supplement: Nutritional SupplementDevice: electroacupuncture

Interventions

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.

nutritional supplement groupnutritional supplements and electroacupuncture group
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).

nutritional supplements and electroacupuncture group

Eligibility Criteria

Age20 Years - 29 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Dietary SupplementsElectroacupuncture

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCombined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Hossam Kamel, professor

    Al-Azhar University

    STUDY DIRECTOR

  • Abeer El-Deeb, professor

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start

August 31, 2025

Primary Completion

December 26, 2025

Study Completion

January 30, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations

EG(1)