Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder
- Conditions
- Premenstrual Dysphoric Disorder
- Interventions
- Other: AcupunctureOther: Tryptophan-Rich DietOther: Vitamin B6 Supplementation
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 39
- 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
- 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
- Arm && Interventions
Group Intervention Description Acupuncture + Tryptophan rich diet + vitamin B6 supplementation Tryptophan-Rich Diet 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 Acupuncture + Tryptophan rich diet + vitamin B6 supplementation Vitamin B6 Supplementation 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 Acupuncture + Vitamin B6 supplementation Vitamin B6 Supplementation 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 Acupuncture + Vitamin B6 supplementation Acupuncture 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 Tryptophan rich diet + vitamin B6 supplementation Tryptophan-Rich Diet 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 Tryptophan rich diet + vitamin B6 supplementation Vitamin B6 Supplementation 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 Acupuncture + Tryptophan rich diet + vitamin B6 supplementation Acupuncture 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
- 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)