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

NCT ID: NCT05813366

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-25
• Study Completion Date: 2023-07-25

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.

Conditions

Premenstrual Dysphoric Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tryptophan rich diet + 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

Group Type: EXPERIMENTAL

Tryptophan-Rich Diet

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Acupuncture + 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

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

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.

Vitamin B6 Supplementation

Intervention Type: OTHER

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.

Acupuncture + Tryptophan rich diet + 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

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nahla Mohamed Ashour Gebril

Demonstrator at Physical Therapy department of Women's Health , Faculty of Physical Therapy, Horus University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nahla Mohamed Ashour

Role: CONTACT

nashour@horus.edu.eg

01050069089

Manal Ahmed El-shafei

Role: CONTACT

manalpt1989@gmail.com

01220664518

Other Identifiers

P.T.REC/012/003877

Identifier Type: -

Identifier Source: org_study_id