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

Not Applicable

Not yet recruiting

• Conditions: Premenstrual Dysphoric Disorder

• Registration Number: NCT05813366
• Lead Sponsor: Cairo University

Brief 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

Detailed Description

This study will be conducted on 39 participants suffering from premenstrual dysphoric disorder (PMDD). They will be recruited from Horus University, New Damietta, Egypt.

Study Timeline

• Study First Submitted: 2023-03-30
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-12
• Last Update Submitted: 2023-04-12
• Study First Posted: 2023-04-14
• Last Update Posted: 2023-04-14
• Study Start: 2023-04-25
• Primary Completion: 2023-06-25
• Study Completion: 2023-07-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Premenstrual Symptoms Screening Tool (PSST)	Up to 2 months	It is a validated, simple, user-friendly screening tool to identify women who suffer from severe Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD). It reflects and 'translates' categorical Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria into a rating scale with degrees of severity (Not at all, mild, moderate, severe). The scoring will be as follows: the following criteria must be present for a diagnosis of PMDD: * At least one of #1, #2, #3, and #4 is severe.; * In addition at least four of #1 - #14 are moderate to severe.; * At least one of A, B, C, D and E is severe.
Hamilton Depression Rating Scale (HDRS)	Up to 2 months	The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale. HRSD provides a reliable and valid assessment of depression.; Method for scoring varies by version. For the HDRS17, a score of 0 - 9 is generally accepted to be within the normal range, 10 - 13 mild, 14-17 mild to moderate and \>17 moderate to severe

Secondary Outcome Measures

Name	Time	Method
Quality of Life Enjoyment and Satisfaction Questionnaire - short form	Up to months 2	It evaluates overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being and medications.; Responses are scored on a 5-point scale ("very poor" to "very good"), where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70). Previous study had shown that it is reliable, valid and sensitive assessments of the individuals' quality of life (QOL)