Premenstrual Dysphoric DisorderNCT05813366
Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder
A study testing Acupuncture, Tryptophan-Rich Diet and Vitamin B6 Supplementation in people with Premenstrual Dysphoric Disorder, run by Cairo University.
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… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Dysphoric Disorder
- What is being tested?
- Acupuncture, Tryptophan-Rich Diet and Vitamin B6 Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2023to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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
Read the 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.
- Conditions
- Premenstrual Dysphoric Disorder
- Being tested
- Acupuncture, Tryptophan-Rich Diet, Vitamin B6 Supplementation
- Medical subject headings
- Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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 DietOther
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 SupplementationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tryptophan rich diet + vitamin B6 supplementation | Experimental | 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 Receives: Other: Tryptophan-Rich Diet; Other: Vitamin B6 Supplementation |
| Acupuncture + Vitamin B6 supplementation | Experimental | 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 Receives: Other: Acupuncture; Other: Vitamin B6 Supplementation |
| Acupuncture + Tryptophan rich diet + vitamin B6 supplementation | Experimental | 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 Receives: Other: Acupuncture; Other: Tryptophan-Rich Diet; Other: Vitamin B6 Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 months
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
Measured: Up to 2 months
Secondary outcomes (1)
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)
Measured: Up to months 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start25 Apr 2023 (estimated)
- Primary completion25 Jun 2023 (estimated)
- Study completion25 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual Dysphoric DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Mohamed Ashour Gebril, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813366
- Sponsor's protocol ID
- P.T.REC/012/003877
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Tryptophan Rich Diet and Acupuncture on Depression Related to Premenstrual Dysphoric Disorder
- ClinicalTrials.gov ID
- NCT05813366
- Acronym / sponsor ID
- P.T.REC/012/003877
- Conditions
- Premenstrual Dysphoric Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Apr 2023 (estimated)
- Primary completion
- 25 Jun 2023 (estimated)
- Study completion
- 25 Jul 2023 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tryptophan rich diet + vitamin B6 supplementation | Experimental | Other: Tryptophan-Rich Diet, Other: Vitamin B6 SupplementationIt 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 + Vitamin B6 supplementation | Experimental | Other: Acupuncture, Other: Vitamin B6 SupplementationIt 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 + Tryptophan rich diet + vitamin B6 supplementation | Experimental | Other: Acupuncture, Other: Tryptophan-Rich Diet, Other: Vitamin B6 SupplementationIt 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 |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureTony 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. | Other | Acupuncture + Tryptophan rich diet + vitamin B6 supplementation, Acupuncture + Vitamin B6 supplementation |
| Tryptophan-Rich DietAll 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. | Other | Acupuncture + Tryptophan rich diet + vitamin B6 supplementation, Tryptophan rich diet + vitamin B6 supplementation |
| Vitamin B6 SupplementationAll 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. | Other | Acupuncture + Tryptophan rich diet + vitamin B6 supplementation, Acupuncture + Vitamin B6 supplementation, Tryptophan rich diet + vitamin B6 supplementation |
Primary outcome
The Premenstrual Symptoms Screening Tool (PSST)
Time frame: 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)
Time frame: 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
1 secondary outcome
Quality of Life Enjoyment and Satisfaction Questionnaire - short form
Time frame: Up to months 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture, Tryptophan-Rich Diet and Vitamin B6 Supplementation in people with Premenstrual Dysphoric Disorder, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nahla Mohamed Ashour (01050069089, nashour@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Premenstrual Symptoms Screening Tool (PSST) (time frame: Up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.