Back to resultsCombined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder
Primary Purpose
Premenstrual Dysphoric Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Tryptophan-Rich Diet
Vitamin B6 Supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Dysphoric Disorder
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Tryptophan rich diet + vitamin B6 supplementation
Acupuncture + Vitamin B6 supplementation
Acupuncture + Tryptophan rich diet + vitamin B6 supplementation
Arm 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
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
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
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05813366
Brief Title
Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder
Official Title
Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 25, 2023 (Anticipated)
Primary Completion Date
June 25, 2023 (Anticipated)
Study Completion Date
July 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Dysphoric Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tryptophan rich diet + vitamin B6 supplementation
Arm Type
Experimental
Arm 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
Arm Title
Acupuncture + Vitamin B6 supplementation
Arm Type
Experimental
Arm 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
Arm Title
Acupuncture + Tryptophan rich diet + vitamin B6 supplementation
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tryptophan-Rich Diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vitamin B6 Supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Premenstrual Symptoms Screening Tool (PSST)
Description
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.
Time Frame
Up to 2 months
Title
Hamilton Depression Rating Scale (HDRS)
Description
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
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Quality of Life Enjoyment and Satisfaction Questionnaire - short form
Description
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)
Time Frame
Up to months 2
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nahla Mohamed Ashour
Phone
01050069089
Email
nashour@horus.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Manal Ahmed El-shafei
Phone
01220664518
Email
manalpt1989@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder
We'll reach out to this number within 24 hrs