UnknownNot Applicable

Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder

39 participantsStarted 2023-04-25

Plain-language summary

Premenstrual Dysphoric Disorder (PMDD) is a severe form of premenstrual syndrome (PMS) affecting up to 8% of reproductive age women. It is characterized by physical and psychological symptoms that occur in the luteal phase of the menstrual cycle, prior to the onset of menses, and leads to negative impact on the psychosocial functioning of affected individuals. Selective serotonin reuptake inhibitors are usually used to treat PMDD but they have several side effects so it is important to use complementary treatment such as tryptophan-rich diet and acupuncture for women with PMDD . The purpose of the current study is to determine the combined effect of tryptophan-rich diet and acupuncture on depression related to premenstrual dysphoric disorder

Who can participate

Age range

20 Years – 30 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All females will be clinically diagnosed with premenstrual dysphoric disorder (PMDD) as confirmed and referred from the gynaecologist. * All females will be firstly assessed by Hamilton Depression rating scale (HDRS) for two months to confirm depression related to PMDD before participating in the study. * Their ages will be ranged from 20 to 30 years. * Their BMI will be ranged from 20 to 25 kg/m. * Being virgin. * Having regular menstruation for the last 6 months (every 28- 35 days with no intermittent bleeding). * All females have a sedentary lifestyle. * Voluntary acceptance of participation in the study Exclusion Criteria: * Using hormonal contraception (such as oral contraceptives and injections). * Menstrual irregularity. * Using diuretics or psychiatric medications. * Using chronic non-steroidal anti-inflammatory drugs. * Pre-diagnosed with any other psychological problems not related to PMDD. * Follow any exercise programs.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Premenstrual Symptoms Screening Tool (PSST)

Timeframe: Up to 2 months

Hamilton Depression Rating Scale (HDRS)

Timeframe: Up to 2 months

Trial details

NCT IDNCT05813366

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-25

Contact for this trial

Nahla Mohamed Ashour

01050069089 nashour@horus.edu.eg

View on ClinicalTrials.gov More Premenstrual Dysphoric Disorder trials