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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Premenstrual Dysphoric Disorder

Treatments: Other: Acupuncture; Other: Tryptophan-Rich Diet; Other: Vitamin B6 Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT05813366

P.T.REC/012/003877

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 estimated patients

Sex: Female

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 3 patient groups

Tryptophan rich diet + vitamin B6 supplementation

Experimental group

Description:

It will include 13 participants suffering from premenstrual dysphoric disorder (PMDD) who will be treated by diet rich wit tryptophan (high protein diet) for 8 weeks in addition to vitamin B6 tablets 60 mg once/day, throughout two menstrual cycles, starting from the first day of their menstrual cycle

Treatment:

Other: Tryptophan-Rich Diet

Other: Vitamin B6 Supplementation

Acupuncture + Vitamin B6 supplementation

Experimental group

Description:

It will include 13 participants suffering from premenstrual dysphoric disorder (PMDD) who will be treated by acupuncture twice a week for 8 weeks, resulting in a total of 16 visits. Each visit, including initial care, needle application and needle retention, will last about 45 min. In addition to vitamin B6 tablet 60mg once/day, throughout two menstrual cycles, starts from the first day of their menstrual cycle

Treatment:

Other: Acupuncture

Other: Vitamin B6 Supplementation

Acupuncture + Tryptophan rich diet + vitamin B6 supplementation

Experimental group

Description:

It will include 13 participants suffering from premenstrual dysphoric disorder (PMDD) who will be treated by diet rich with tryptophan (high protein diet) for 8 weeks and acupuncture twice a week for 8 weeks, resulting in a total of 16 visits. Each visit, including initial care, needle application and needle retention, will last about 45 min. In addition to vitamin B6 tablet 60mg once/day, throughout two menstrual cycles, starts from the first day of their menstrual cycle

Treatment:

Other: Acupuncture

Other: Tryptophan-Rich Diet

Other: Vitamin B6 Supplementation