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

Premenstrual Dysphoric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05813366
• Other study ID #: P.T.REC/012/003877
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: April 2023
• Source: Cairo University
• Contact: Nahla Mohamed Ashour
• Phone: 01050069089
• Email: nashour[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: July 25, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premenstrual Dysphoric Disorder

Intervention

Other:
• Acupuncture
Tony disposable, single-use 0.20×40 mm Chinese needles will be used. The needle penetrates the skin sufficiently to reach the required depth and elicit de qi. The needles remains for 30 min, with gentle rotational movements applied three times during the session.
• Tryptophan-Rich Diet
All participants in both groups (A and C) will be treated by high protein foods rich with tryptophan including: chicken , turkey, red meat, salmon, fish, tuna, beans, milk, cheese, seeds, nuts, egg, banana, kiwi, leafy greens, mushroom, broccoli and peas, etc. Total daily calorie intake will be calculated for each participant in both groups (A and C) before diet description. All females will serve the meals that met their required kilocalorie levels and physical activity levels so that the participants will not lose weight, feel hungry or be over-fed.
• Vitamin B6 Supplementation
All participants in all groups (A, B and C) will receive a tablet of vitamin B6 60mg once/day for 8 weeks, starting from the first day of their menstrual cycle, throughout two menstrual cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Premenstrual Symptoms Screening Tool (PSST)	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.	Up to 2 months
Primary	Hamilton Depression Rating Scale (HDRS)	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	Up to 2 months
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire - short form	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)	Up to months 2